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Title:
METHOD FOR TREATING INFECTIOUS CONDITIONS OF MUCOSAE AND MUCO−CUTANEOUS TISSUE
Document Type and Number:
WIPO Patent Application WO/2003/049750
Kind Code:
A1
Abstract:
This invention relates to a method of and solutions suitable for use in the treatment of infectious conditions of mucosae and muco−cutaneous tissue resulting from various microorganisms in humans and animals, especially various causative agents of sexually transmitted disease, including viruses, bacteria and fungi. It particularly relates to the treatment of herpes lesions in patients and to the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea. The method includes the steps of electrochemically activating a dilute aqueous saline solution such that it includes separable and both of an aqueous, mixed oxidant, predominantly anion−containing solution and an aqueous, mixed reductant, predominantly cation−containing solution&semi applying the aqueous, mixed oxidant, predominantly anion−containing solution to an affected lesion&semi and once the anolyte solution dries up, applying the aqueous, mixed reductant, predominantly cation−containing solution.

Inventors:
HINZE GILBERT THEO (ZA)
Application Number:
PCT/ZA2002/000196
Publication Date:
June 19, 2003
Filing Date:
December 09, 2002
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
RADICAL WATERS IP PTY LTD (ZA)
HINZE GILBERT THEO (ZA)
International Classes:
A61K33/00; A61K33/06; A61K33/08; A61K33/10; A61K33/14; A61K33/20; A61K33/40; A61K45/06; (IPC1-7): A61K33/04; A61K33/14; A61K33/20; A61K33/40
Domestic Patent References:
WO1999020286A11999-04-29
WO1999020287A11999-04-29
WO1999034652A11999-07-08
Foreign References:
CA2261278A12000-08-04
Other References:
INOUE Y ET AL: "TRIAL OF ELECTROLYZED STRONG ACID AQUEOUS SOLUTION LAVAGE IN THE TREATMENT O PERITONITIS AND INTRAPERITONEAL ABSCESS", ARTIFICIAL ORGANS, BLACKWELL SCIENTIFIC PUBLICATIONS, INC., BOSTON, US, vol. 21, no. 1, 1997, pages 28 - 31, XP001064985, ISSN: 0160-564X
Attorney, Agent or Firm:
Le Roux, Marius (D M Kisch Inc PO Box 8 2146 Sandton, ZA)
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Claims:
CLAIMS
1. A method of treating a human or animal body suffering from infectious conditions of mucosae and mucocutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi, the method including the steps of electrochemically activating a dilute aqueous solution such that the electrochemically activated, aqueous solution includes separable and both of an aqueous, mixed oxidant, predominantly anioncontaining solution and an aqueous, mixed reductant, predominantly cationcontaining solution; separating the aqueous, mixed oxidant, predominantly anioncontaining solution from the aqueous, mixed reductant, predominantly cationcontaining solution; applying the aqueous, mixed oxidant, predominantly anioncontaining solution to an affected area; and after use of the aqueous, mixed oxidant, predominantly anioncontaining solution applying the aqueous, mixed reductant, predominantly cation containing solution.
2. The method as claimed in claim 1 characterised therein that the aqueous, mixed reductant, predominantly cationcontaining solution is only applied once the aqueous, mixed oxidant, predominantly anioncontaining solution has substantially dried up.
3. The method as claimed in claim 1 characterised therein that both the aqueous, mixed oxidant, predominantly anioncontaining solution and the aqueous, mixed reductant, predominantly cationcontaining solution are each applied to an affected lesion at least once a day for at least 5 minutes at a time.
4. The method as claimed in claim 1 characterised therein that the aqueous, mixed oxidant, predominantly anioncontaining and the aqueous, mixed reductant, predominantly cationcontaining solutions are applied to an affected area at least four times a day.
5. The method as claimed in claim 1 characterised therein that method is particularly suitable for treatment of herpes lesions in a human or animal body and for the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases, such as syphilis and gonorrhoea.
6. The method as claimed in claim 1 characterised therein that the method extends to the treatment of genital and similar lesions, caused by microorganisms, especially herpes related virus found in domestic and other animals where reproductive failure and abortion are consequences of the infection.
7. The method as claimed in claim 1 characterised therein that the electrochemically activated, aqueous solution is selected from a group consisting of an anioncontaining solution; a cationcontaining solution ; a mixture of an anioncontaining solution and a cationcontaining solution ; an anioncontaining solution having been prepared from an anioncontaining solution, a cationcontaining solution or a mixture of an anioncontaining solution and a cationcontaining solution ; and a cationcontaining solution having been prepared from an anioncontaining solution, a cationcontaining solution or a mixture of an anioncontaining solution and a cationcontaining solution.
8. The method as claimed in claim 1 characterised therein that the electrochemically activated, aqueous solution is prepared by means of electrolysis of an aqueous solution of a salt.
9. The method as claimed in claim 8 characterised therein that the salt is selected from a group consisting of alkali and alkali earth metal chlorides;carbonates ; bicarbonates;phosphates ; sulphates, ornitrates; for example, sodium chloride; noniodated sodium chloride ; potassium chloride; calcium chloride; sodium carbonate;bicarbonate ; andphosphate; potassium carbonate; bicarbonate; andphosphate; calcium phosphate; sodium ;potassium ; and calcium nitrate; and a mixture of at least two of the aforementioned salts.
10. The method as claimed in claim 8 characterised therein that the electrochemically activated, aqueous solution is produced from an aqueous salt solution having a concentration of between 0. 0001% to 10%, and for some specific systems without predilution of the feed, preferably between about 0.3% and 0.5% aqueous salt solution.
11. The method as claimed in claim 1 characterised therein that the electrochemically activated, aqueous solution is produced by an electrochemical reactor or electrolysis device having a through flow electro chemical cell with two caxial cylindrical electrodes, with a tubular ceramic diaphragm located coaxially between the two electrodes so as to separate an annular interelectrode space into a coaxial, annular catholytic and an annular anolytic chamber arrangement, wherein the electrochemical cell has a relatively small, annular, crosssectional total open area for fluid flow, preferably of about 180mm2, for causing turbulent fluid flow there through.
12. The method as claimed in claim 1 characterised therein that the anolyte and catholyte are produced in the electrochemical cell under a relatively low current of about 5A to 8A, and a relatively high voltage of about 6V to 48V, and more preferably between 8V and 24V.
13. The method as claimed in claim 1 characterised therein that the mixed oxidant and mixed reductant species of the anolyte and catholyte are labile such that after about 96 hours, the concentration and activity of the various activated species reduce substantially with relatively little, alternatively no active residues remaining.
14. The method as claimed in claim 1 characterised therein that the anolyte solution has a redox potential of about between +300 mV and +1200 mV, and a pH of between 2 and 8, and preferably a pH of 7; and wherein the catholyte solution has a pH of between 7 and 13, and preferably a pH of about 11.5, and a redox potential of between200 mV and1100 mV, and preferably of about 800 mV.
15. The method as claimed in claim 1 characterised therein that the anolyte solution includes mixed oxidant species such as CIO ; CIO ; HCIO ; OH ; HO2; H202; Os ; S2082~ and C12062.
16. The method as claimed in claim 1 characterised therein that the catholyte solution includes mixed reductant species such as OH ; Hg' ; 02 ; H2 ; H02 ; H02 and 02.
17. The method as claimed in claim 1 characterised therein that the anolyte contains organic radicals and other components such as Cl2, HClO, ClO, ClO#, Cl#, HO2, HO2#, O2, HO#, O3, O2#, 3O2, O2, O#, H3O+, Cl#, H#, H2O2, Cl2O, ClO2#, HCI, Cl2O7, S2082, C2062, HCIO, H2SO4, and HSO3Cl.
18. The method as claimed in claim 1 characterised therein that the catholyte contains organic radicals and other components such as HO', H302', O2, HO2, H202, H2, HO, H2, NaOH, KOH, Ca (OH) 2 and Mg (OH) 2.
19. The method as claimed in claim 1 characterised therein that the physical and chemical characteristics, including specific conductivity, redox potential and pH, concentration of activated species and other characteristics of the anolyte and catholyte are adjusted for particular applications by varying levels of saline concentration and the mineral content of the feed water, as well as the operational variables of the electrochemical reactor, including flow rates, flow regimes, paths andrates of recycle, currents and potential differences.
20. Use of an electrochemically activated, aqueous saline solution in the treatment of infectious conditions of mucosae and mucocutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi.
21. The use as claimed in claim 20 characterised therein that the electrochemically activated, aqueous saline solution is particularly used in the treatment of herpes lesions in a human or animal body and for the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea.
22. Use of an electrochemically activated, aqueous saline solution in the preparation of a medicament for use in the treatment of infectious conditions of mucosae and mucocutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi herpes lesions in a human or animal body, and for use in the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea.
23. Use of an electrochemically activated, aqueous solution in the treatment of a birth canal in infected mothers, wherein the birth canal is douched with the electrochemically activated, aqueous solution before natural delivery for decontaminating the birth canal so as to prevent a baby from coming into contact with infectious microorganisms present in the birth canal.
24. A method of treating a human or animal body suffering from genital ulcerations caused by herpes simplex virus type 1 (HSV1) and particularly herpes simplex virus type 2 (HSV2) infections, the method including the steps of electrochemically activating a dilute aqueous solution such that the electrochemically activated, aqueous solution includes separable and both of an aqueous, mixed oxidant, predominantly anioncontaining solution and an aqueous, mixed reductant, predominantly cationcontaining solution; separating the aqueous, mixed oxidant, predominantly anioncontaining solution from the aqueous, mixed reductant, predominantly cationcontaining solution ; applying the aqueous, mixed oxidant, predominantly anioncontaining solution to an affected area; and once the anolyte has substantially dried up, applying the aqueous, mixed reductant, predominantly cationcontaining solution.
Description:
METHOD FOR TREATING INFECTIOUS CONDITIONS OF MUCOSAE AND MUCO-CUTANEOUS TISSUE Introduction This invention relates to a method of and solutions suitable for the treatment of infectious conditions of mucosae and muco-cutaneous tissue resulting from various microorganisms in humans and animals, especially various causative agents of sexually transmitted disease, including viruses, bacteria and fungi. It particularly relates to the treatment of herpes lesions in patients and to the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea. More particularly, but not exclusively, the invention relates to the treatment of patients, including those with a compromised immune system, with genital ulcerations caused by herpes simplex virus type 1 (HSV-1) and particularly herpes simplex virus type 2 (HSV-2) infections.

Additionally, the invention relates to the treatment of genital and similar lesions, caused by microorganisms, especially herpes related virus found in domestic and other animals where reproductive failure and abortion are consequences of the infection.

Background to the invention There are two main types of herpes simplex viruses (HSV), namely HSV-1 and HSV-2.

Type HSV-1 most commonly results in"cold sores"or fever blisters on the face, although it may in some instances be a cause of genital herpatic lesions.

Type HSV-2, however, is the most common cause of genital herpatic lesions (up to 95%). Symptoms of patients suffering from HSV-2 vary widely and may include one or more of the following : i) Itching or pain in the genital and perianal areas, as well as on the buttocks, lower back and thighs; ii) Blisters in the genital and perianal areas that burst and are associated in males with swelling and erythema of the foreskin and shaft of the penis. In women, discrete and coalescing lesions on the labia minora and labia majora may occur.

Similar lesions may also occur on the buttocks, thighs and groin; iii) Neonatal herpes in infants may occur especially during vaginal delivery if the mother acquired an infection during the last trimester of pregnancy. Such infants may suffer from severe neurological impairment and even die; and iv) Patients with a compromised immune system, such as those with an advanced HIV infection, may develop persistent, invasive lesions. In such patients the prevalence of virus resistance to"Aciclovir" (an anti-viral medication) may be as high as 5-10% and the virus may be associated with considerable morbidity and mortality.

Current first world treatment methods are based on the use of oral antiviral and supportive treatments in primary or first episode herpatic infections. For patients with recurrent HSV-2 infections use of saline baths and short courses of antiviral treatments are advised. Ideally, patients should hold a stock of antiviral drugs for self-treatment. In HIV sufferers, successful treatments are seldom accomplished, especially in parts of the world where the infection rates are very high. Antiretrovirals for HIV patients are not

commonly used due to the high cost of these drugs and antivirals for genital HSV infections are used even less. The net result is that the incidence of genital HSV infections is very high and rising in these populations.

The seventh Sentinel Surveillance, conducted by the AIDS/STD Unit, Ministry of Health of Botswana in 1998 revealed that seroprevalence of HIV amongst pregnant women tested was 1614 out of 4194 (33.5%), reaching 42.8% and 45.2% in the age groups 20- 24 and 25-29 respectively. In men with STD's the seroprevalence of HIV was 60.73%, whilst 61.3% also had genital ulcers. This data was compiled over a period of 12 weeks in 9 clinics in that country. (Population estimate is 1,533, 393). This is in sharp contrast to the total of 28,000 cases of genital herpes reported in the same year (1998) in England with a much larger population of over 60 000 000. There exists a much larger need for the treatment of HIV/Aids related symptoms including genital ulcers in these areas where home-based care is the norm.

Object of the invention It is accordingly an object of this invention to provide a more cost effective method for treating herpes lesions in patients, which will make the treatment more readily available to a larger portion of the population.

Summary of the invention According to the invention there is provided a method of treating a human or animal body suffering from infectious conditions of mucosae and muco-cutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi, the method including the steps of electrochemically

activating a dilute aqueous solution such that the electrochemically activated, aqueous solution includes separable and both of an aqueous, mixed oxidant, predominantly anion-containing solution and an aqueous, mixed reductant, predominantly cation- containing solution ; separating the aqueous, mixed oxidant, predominantly anion- containing solution from the aqueous, mixed reductant, predominantly cation-containing solution; applying the aqueous, mixed oxidant, predominantly anion-containing solution to an affected lesion ; and after use of the aqueous, mixed oxidant, predominantly anion- containing solution applying the aqueous, mixed reductant, predominantly cation- containing solution.

The method may be characterised therein that the aqueous, mixed reductant, predominantly cation-containing solution is only applied once the aqueous, mixed oxidant, predominantly anion-containing solution has substantially dried up.

The aqueous, mixed oxidant, predominantly anion-containing solution and the aqueous, mixed reductant, predominantly cation-containing solution may be applied by means of a rinse, douche, lavage, spray and/or swabbing by a soaked bandage, towel or cotton wool.

The method may include applying the aqueous, mixed oxidant, predominantly anion- containing solution to an affected lesion at least once a day for at least 5 minutes at a time and, once the lesion dries up, applying the aqueous, mixed reductant, predominantly cation-containing solution also for at least 5 minutes at a time. In a preferred form of the invention, the aqueous, mixed oxidant, predominantly anion-

containing and aqueous, mixed reductant, predominantly cation-containing solutions are applied at least four times a day.

Without derogating from the generality of the aforegoing, method may characterised therein that it is particularly suitable for treatment of herpes lesions in a human or animal body and for the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea.

Additionally, the invention relates to the treatment of genital and similar lesions, caused by microorganisms, especially herpes related virus found in domestic and other animals where reproductive failure and abortion are consequences of the infection.

The electrochemically activated, aqueous solution may be selected from a group consisting of an anion-containing solution; a cation-containing solution; a mixture of an anion-containing solution and a cation-containing solution; an anion-containing solution having been prepared from an anion-containing solution, a cation-containing solution or a mixture of an anion-containing solution and a cation-containing solution ; and a cation- containing solution having been prepared from an anion-containing solution, a cation- containing solution or a mixture of an anion-containing solution and a cation-containing solution.

The predominantly anion-containing solution is referred to hereinafter for brevity as the "anolyte solution"or"anolyte", and the predominantly cation-containing solution is referred to as the"catholyte solution"or"catholyte".

The electrochemically activated, aqueous solution may be prepared by means of electrolysis of an aqueous solution of a salt. The salt may be selected from the group consisting of alkali and alkali earth metal chlorides ; -carbonates;-bi-carbonates ; - phosphates ;-sulphates, or-nitrates; for example, sodium chloride ; non-iodated sodium chloride ; potassium chloride ; calcium chloride ; sodium carbonate;-bicarbonate ; and- phosphate; potassium carbonate;-bicarbonate ; and-phosphate; calcium phosphate; sodium- ;-potassium ; and calcium nitrate; and a mixture of at least two of the aforementioned salts.

The electrochemically activated, aqueous solution may be produced from a relatively low concentration aqueous salt solution. Depending on the particular process being performed, and the method for producing the electrochemically activated solution (e. g. with or without pre-dilution of the feed solutions), the aqueous salt solution concentration may be between 0. 0001% to 10%, and for some specific systems without pre-dilution of the feed, preferably between about 0.3% and 0. 5% aqueous salt solution.

The anolyte and the catholyte may be produced by an electrochemical reactor or so- called electrolysis device, having a through flow electro-chemical cell with two co-axial cylindrical electrodes, with a tubular ceramic diaphragm located co-axially between the two electrodes so as to separate an annular inter-electrode space into a co-axial, annular catholytic and an annular anolytic chamber arrangement. The electrochemical cell may have predetermined design and geometrical relationships, ensuring optimum fluid flow and recirculations patterns. The cell may have a relatively small, annular, cross-sectional total open area for fluid flow, preferably of about 180mm2, thus causing

turbulent fluid flow there through so as to ensure maximum exposure of the solutions to the electric field.

The anolyte and the catholyte may be produced in the electrochemical cell under predetermined operational parameters, including a relatively low current, preferably of about 5A to 8A, and a relatively high voltage, preferably of about 6V to 48V, and more preferably between 8V and 24V, thus providing a relatively high voltage gradient or electric field intensity at the interface between the electrode surface and electrolyte, estimated to be about 106 V/cm.

The salt solution may be electrolysed to produce the anolyte and the catholyte with mixed oxidant and mixed reductant species. These species may be labile and after about 96 hours, the concentration and activity of the various activated species may reduce substantially with relatively little, alternatively no active residues remaining.

The anolyte solution may have a redox potential of about between +300mV and +1200mV. The anolyte solution may have a pH of between 2 and 8, and preferably a pH of 7. Depending on the salt (s) in the feed stream used in the activation process, the anolyte solution may include mixed oxidant species such as CIO ; CIO- ; HCIO ; OH-; HO2- ; H202 ; 03 ; S208 and C1206 The catholyte solution generally may have a pH of between 7 and 13, and preferably a pH of about 11.5, and a redox potential of between-200 mV and-1100mV and preferably of about-800mV. Depending on the salt (s) in the feed stream, the catholyte

solution may include mixed reductant species such as OH- ; Hs' ; 02 ; H2 ; HO2# ; HO2-and 02-.

Depending on the source of the water and the salt used, anolyte may contain organic radicals and other components such as Cl2, HCIO, CIO-, CIO, Cl, HO2, HO2, O2, HO, <BR> <BR> <BR> <BR> <BR> O 0,, 30 0,, O#, H3O+, Cl#, H#, H2O2, Cl2O, ClO2-, HCl, Cl2O7, S2O82-, C2O62-, HClO, H2SO4, and HSO3CI. Catholyte may contain HO-, H302, 02, HO2, H202, H2, HO, H2, NaOH, KOH, Ca (OH) 2 and Mg (OH) 2. Analysis of the inorganic components of these solutions has shown varying quantities of aluminium, calcium, magnesium, manganese, potassium, sodium, molybdenum, ammonium, orthophosphate, silica and chloride.

According to another aspect of the invention there is provided the use of an electrochemically activated, aqueous saline solution in the treatment of infectious conditions of mucosae and muco-cutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi.

The invention specifically provides for the use of an electrochemically activated, aqueous saline solution in the treatment of herpes lesions in a human or animal body and for the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea.

According to another aspect of the invention there is provided the use of an electrochemically activated, aqueous saline solution in the preparation of a medicament

for use in the treatment of infectious conditions of mucosae and muco-cutaneous tissue resulting, inter alia, from causative agents of sexually transmitted diseases including viruses, bacteria and fungi herpes lesions in a human or animal body, and for use in the treatment of fungal and yeast infections such as thrush, caused by Candida albicans, and associated opportunistic bacterial infections, as well as other sexually transmitted diseases (STD) such as syphilis and gonorrhoea.

According to another aspect of the invention there is provided the use of an electrochemically activated, aqueous solution in the treatment of a birth canal in infected mothers, wherein the birth canal is douched with the electrochemically activated, aqueous solution before natural delivery for decontaminating the birth canal so as to prevent a baby from coming into contact with infectious micro-organisms present in the birth canal.

The applicant believes that anolyte is a potent decontaminant and antiviral substance, whilst catholyte positively mediates healing and tissue regeneration due to its potent antioxidant and other physico-chemical properties.

Examples of the invention Clinical trials were conducted at a local STD clinic in Gaborone, Botswana. The results of the trials are set out in tables 1 to 4 hereunder. Several hundred patients attending the STD clinic were treated and a clinical study was undertaken by the Botswana- Harvard Partnership for HIV Research and Education.

All patients were supplied with 500mut anolyte (pH 7.0) and advised to apply the solution topically to the affected lesion for 10 minutes, three times a day using a swab, cloth or cotton wool. A hypotonic solution (0.2% NaCI) was used.

The treatment schedule that was used for the trial was as follows (i. e. for genital herpes ulcers only and only in HIV+ patients): 1. Generation of solutions on-site and fresh solutions to be supplied daily or at least every 2nd day 2. Liberal soaking with anolyte, 6 times per day for 10 minutes; swab to be changed twice during the 10 minutes; 3. Thereafter, soaking with catholyte, 6 times per day for 10 minutes; swab to be changed twice during the 10 minutes; 4. Evaluation of lesions every second day, including the recording of digital images; 5. Cut-off period 14 days.

Results of clinical trial: STD Clinic, Gaborone, Botwana<BR> (Number of days to healing since initial visit to the clinic)<BR> Table 1: Viral Genital conditions (Herpes) treated topically with ECA Solutions<BR> (Unless indicated, no antibiotics were applied) Ref. No Age Sex Diagnosis Date of visit to clinic Remarks 02 41 m Genital Herpes ulcer 16/05 23/05 - - Cured (7) 06 38 m Genital and oral ulcers + warts 08/0522/05 - - Cured (14) 10 27 m Genital Herpes ulcer 08/05 15/05 - - Cured (7) 11 31 f Genital Herpes ulcer 20/05 30/05 - - Slow improvement; patient ESN 7 yrs (-) 12 26 f Genital Herpes ulcer (multiple) 23/04 03/05 30/05 - o show; presumed cured (7) 16 31 m Genital Herpes ulcer 05/06 13/06 - - Cured (8) 17 32 m Genital Herpes ulcer + warts 12/06 14/06 21/06 - Cured (9) 19 22 f Genital ulcer + Herpes Simplex 12/06 15/06 - - Cured (3) 20 25 m Genital Herpes ulcer (renulum) 5/06 18/06 - - Cured (3) 22 24 f Genital Herpes ulcer 18/06 20/06 25/06 - Cured (7) 25 28 m Genital Herpes ulcer 14/06 18/06 - - Cured (4) 26 49 m Genital Herpes ulcer 18/06 20/06 - - Cured (2) 28 35 m Genital Herpes ulcer 19/06 - - - No show; presumed cured (3) 29 46 m Genital Herpes ulcer 19/06 26/06 - - Cured (7) 34 31 m Genital Herpes ulcer (multiple) 21/06 03/07 - - Cured (10) 36 51 m Genital Herpes ulcer (multiple) 25/06 28/06 10/07 - Cured A/B prescribed 2nd visit (15) 37 24 f genital herpes ulcer (multiple) 25/06 27/06 - - Cured (2) 39 28 f Genital Herpes ulcer (multiple) 25/06 29/06 03/07 05/07 Ulcer persists + Catholyte - slow (-) 43 31 f Genital Herpes ulcer 03/07 - - - No show; presumed cured (3) 44 37 m Genital Herpes ulcer 03/07 - - - No show; presumed cured (3) 45 24 m Genital Herpes ulcer (multiple) 03/07 - - - No show; presumed cured (3) 46 29 m Genital Herpes ulcer (multiple) 26/06 03/07 - - A/B prescribed 1st and 2nd visit (?) 47 35 m Genital Herpes ulcer 0/07 09/07 25/07 - Cured (21) 49 42 m Genital Herpes ulcer 28/06 - - - No show; presumed cured (3) 50 21 f Genital Herpes ulcer 28/06 03/07 - - Responding well, Improving (?) 51 m Genital Herpes ulcer 04/07 - - - Improved (:) 53 53 m Genital Herpes ulcer (multiple) 04/07 - - - No show; presumed cured (3) 54 26 f Genital Herpes ulcer 04/07 - - - No show; presumed cured (3) 55 28 f Genital Herpes ulcer 05/07 - - - Cured (3) 56 32 m Genital ulcer + Herpes Simplex 05/07 - - - + Tetracycline No show; presumed cured (3) 57 20 m Genital Herpes ulcer 09/07 13/07 - - Cured (C) (3) 58 29 m Genital Herpes ulcer 09/07 - - - No show; presumed cured (3) 59 22 f Genital Herpes ulcer 10/07 - - - No show; presumed cured (3) 60 25 m Genital Herpes ulcer 11/07 - - - No show; presumed cured (3) 61 36 m Genital Herpes ulcer 11/07 25/07 - - No show; presumed cured (3) 62 29 f Genital Herpes ulcer 18/07 20/07 - - Cured (2) 63 27 f Genital Herpes ulcer 12/07 - - - No show; presumed cured (3) 64 23 f Genital Herpes ulcer 12/07 - - - No show; presumed cured (3) 65 33 f Genital Herpes ulcer 12/07 20/07 - - Cured (2) 66 22 m Genital Herpes ulcer 18/07 - - - No show; presumed cured (3) 67 34 m Genital Herpes ulcer 19/07 23/07 30/07 - Much improved (?) 68 39 f Genital Herpes ulcer 20/07 24/07 - - Cured (4) 69 34 m Genital Herpes ulcer (Septic) 20/07 24/07 - - Lesions dry (-) 70 22 m Genital Herpes ulcer 20/07 23/07 - - Much improved (-) 71 24 f Genital Herpes ulcer 23/07 26/07 - - Cured (3) 72 22 m Genital Herpes ulcer 18/07 24/07 - - Much improved (?) 73 28 m Genital Herpes ulcer 18/07 - - - No show; presumed cured (3) 74 37 m Genital Herpes ulcer 25/07 27/07 - - Slight improvement (3) 75 33 m Genital Herpes ulcer 25/07 - - - 77 37 m Genital Herpes ulcer 23/07 26/07 - - Improving on AB s Table 2: Bacterial Genital conditions<BR> (EAW / ECA solutions applied topically and antibiotics prescribed orally) Ref. No Age Sex Diagnosis Data of visit to clinic Remarks 1 25 f Raw ulcer + warts 15/05 23/05 - - Cured (7) 5 43 m Raw contaminated ulcer 14/05 23/05 - - Slight improvement. Poor hygiene (?) 13 28 f Deep raw ulcer 30/04 09/05 16/05 - Cured (16) 18 20 m Genital ulcer - purulent 13/06 16/06 - - Cured (13) 21 32 f Generalized ulceration of labia 81/06 20/06 25/06 - Cured (7) 23 24 f Genital Ulcer - purulent 14/06 18/06 28/06 - Cured (14) 30 24 m Bacterial deep ulcer 2/06 25/06 28/06 - Cured (8) 31 51 m Bacterial deep ulcer 18/06 29/06 - - Cured (11) 32 39 m Bacterial superificial ulcer 20/06 - - - No show: presumed cured (3) 33 27 m Bacterial deep ulcer 20/06 - - - Cured (3) 38 26 m Bacterial scrotal ulcers 25/06 - - - No show; presumed cured (3) 41 39 f Bacterial episiotomy ulceration 22/06 26/06 04/07 - Abscess developed and burst (?) 42 29 m Bacterial deep ulcer 22/06 03/07 - - Healing (?) Table 3: Chemical irritiation after cryosurgery for the removal of gneitla warts<BR> (Antibiotics only prescribed when indicated) Ref. Age Sex Diagnosis Date of visit to clinic Remarks No 03 24 m Gen warts. Glans irritation 16/05 18/05 25/05 - Cured (9) 04 27 f Gen. Warts. Vulva irritation 02/05 09/05 29/05 - Cured (21) 07 37 f Gen. Warts. Vulva irritation 03/05 09/05 17/05 - Cured (14) 08 22 f Gen. Warts. Vulva irritation 15/05 21/05 - - Cured (14) 09 28 m Gen warts. Glans iritation 16/05 25/05 - - Cured (9 14 33 M Genital Ulcer - purulent 09/05 15/05 22/05 - Cured (13) 24 24 f Deep raw ulce r- purulent 14/06 18/06 - - Cured (4) 27 26 m Gen. Warts + ulceration 12/06 19/06 26/06 - Cured (14) 35 27 f Vulva ulceration + pain 22/06 25/06 28/06 - cured (5) 40 22 m Genital Ulcer - purulent 18/06 26/06 - - Cured (7) 52 24 f Extensive genital warts. Irr. 04/07 09/07 - - Improved (?) Table 4: Summary of Results Genital Herpes Male patients Days Female Patients Days Total Cured 17/19 89.5% 7.9 8/11 72.7% 3.3 25/30 (83.3%) No Show 12/31 38.7% 6/17 35.4% 18/48 (37.5%) No Cured 2/19 10.5% 3/11 27.7% It will be appreciated that many variations in detial are possible without departing from the scope or spirit of the invention as defined in<BR> the claims.