Below are some of the results from Clinical trials.   The time to heal is now!

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Clinical Studies clst1

Homeopathy and Herpes Clinical StudyUSE IN GENERAL PRACTICE British Homeopathic Journal Extract: Evaluation of 2LHERP (RNA & DNA complex) in preventing recurrences of genital herpes. M. Jenaer-, M.F. Henry, A Garcia and B Marichal on behalf of the Institut International 3IL7Z The Objective of the study was to evaluate the effectiveness of a homeopathic complex in terms of intensity of attacks and duration of remission between attacks of genital herpes. Fifty three patients aged 18 or over with a minimum of four attacks annually were followed in this open multi-centre study in a primary care setting. The principal parameters analysed were: frequency of attacks; intensity of symptoms, during treatment and /or after stopping treatment; treatment tolerance. Eighty two per cent of patients treated for recurrent genital herpes benefited. In 41 % of cases, there was no recurrence after the first treatment with follow-up of between 8 and 50 months. In 32% of patients, one or two relapses, in 9 % of patients, recurrences continued but with reduced frequency and intensity.

Extract from the British Homeopathic Journal (2000) 89,174-177 Further information can be obtained from IDI, 5 St John's Lane. London. EC 1M 4BH. Tel: 020 7549 1642. Fax: 020 7549 1643 Case Study Recurrent Cold Sores Cold sores which recur can be just as debilitating as genital herpes. The following case demonstrates that the RNA/DNA/SNA formula 2LHERP is equally as effective for cold sores as it is for genital herpes. The formula contains two SNA which specifically target the two different Herpes viruses HSV1 and HSV2. A 50 yr old man went to consultation for recurrent cold sores. He had suffered from them for 5 yrs, initially l cold sore per year and then by the time that he consulted the homeopath he was getting 1 cold sore per month. After two months of treatment he no longer had any cold sores, neither during treatment nor after stopping treatment. To date he has been 18 months with no cold sores

Further information and Herpes case studies can be obtained from IDI at the above address. Combining 2LHERP with classical homeopathy By Dr Rosi Coerezza I usually combine most MicroImmunotherapy treatments with the patient's constitutional remedy. For genital herpes I always prescribe 2LHERP for preventing recurrences and advise external tea tree oil during any outbreaks. If there is also candida I often prescribe tea tree oil orally - 1 drop placed on a piece of sugar and swallowed. Local Doctor's Experience in a small French town Reported April 2002, Paris A local general practitioner in a small French town recently told us of his experience with 2LHERP. A patient came to see him who had been suffering from Herpes type 2 for the previous 2 years. She had seen all of the experts in the town, including the chief gynaecological consultant at the town's main hospital. Nothing worked. The doctor tried the patient on 2LHERP and within one month The patient showed great improvement. This produced a `petite revolution' in the town - the rumour spread quickly. After a few weeks the doctor received most of the town's herpes cases. Happy with the treatment success he decided to share it with the `officials' of the town including the hospital VIP's. He never got an answer. `But then this is France!' he shrugs.

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Herpigen Clinical StudyHerpigen Clinical StudyClinical efficacy of "HERPIGEN" in management of the female herpes genitalis

Doschanova A.M. - State National Medical University, Almaty

AIM:

To assess efficacy of "HERPIGEN", an anti-viral preparation in management of females with herpes genitalis.

Materials and methods

22 females aged from 21 to 38 with clinical implications of herpetic viral infection comprised the group under observation. The infection presence was confirmed by the performed DNA PCR analysis. The patients’ complaints and medical histories were studied with the examination of immunological status (A-, G- and M-class immunoglobulins). The PCR was employed in herpetic virus typing. We managed to assess the preparation efficacy, side effects and complications, presence or absence of ulcerous erosions and recurrence rate of herpetic viral infection.

Method of administration

The performed monotherapy comprised spraying of the skin surface and mucous membranes with "HERPIGEN" 6 times a day for 5-7 days. The females were followed-up 7-10 days after the therapy and further with onemonth interval for 6 months.

Patients’ characteristics: 22 females with clinical implications of herpetic viral infection in exacerbation were examined and managed on the outpatient basis. All the females above had recurring herpes genitalis with various disease duration: the one of less than one year (n=14), from 1 to 5 years (n=6), 6-10 years (n=2). The disease recurrence rate was as follows: once a month (n=5), one time per two months (n=8), one times per three months (n=9). In 7 of 22 patients the rash was registered accompanied by hyperthermia (up to 37.5 degrees of Centigrade), fever, general indisposition and regional lymphadenitis.

Results: the findings of the performed clinical trial are indicative of high "HERPIGEN" efficacy in management of herpetic infections. 20 patients stopped complaining of itch and burning on the 2nd day of the therapy. The reduction of the complaints was observed in 2 females to terminate in all of the patients on the 3rd day of the therapy. First intention and herpetic erosion epithelization were detected to take place on the 2nd day and in the first 3 days of the therapy, respectively. The clinical effect absence was not registered in the management of herpetic affections. The increase in serum IgM was found. Reexamination a month after the therapy revealed no herpes simplex virus in 10 patients, 6 months after the therapy – in 5 more females. 6-month follow-up showed the recurrences in 5 persons. Neither allergic reactions nor side effects were registered.

Conclusion

"HERPIGEN" is a highly efficient, handy and tolerable preparation for external use in management of herpetic infection implications, causing no sides effects. The preparation can be recommended for wide use in medical practice. Slides

1. Advantages of administration in pregnancy:

The "HERPIGEN INTIM" spray - requires no special medical skills, being handy and easy in use without assistance;

- produces rapid therapeutic effect; - being natural, produces no allergic and side reactions; - evokes no skin irritation, producing fine sanitizing effect; - is rapidly absorbed, being easily removed and leaving no stains on clothes; - has no embryotoxic and teratogenic effect with safety confidently experimentally and clinically confirmed.

2. Indication of use

· Management of herpes viral infection caused by herpes simplex virus both in acute primary and in recurring course. · Herpes viral infection recurrence prevention. · Management of lichen shingles caused by Varicella –Zoster virus (in complex therapy). · Therapy of cytomegalovirus. · Management of papillomavirus infection caused by various types (oncogenic included), of human papilloma virus. · Therapy of non-specific colpitis and vaginosis, vaginal microflora normalization. · As prophylactic anti-viral and anti-inflammatory preparation in sexual intercourse

5. Glycyrrhizic acid is a kinase inhibitor.

It produces: · Anti-viral effect. · Anti-flammatory effect. · Anti-ulcerous effect · Anti-bacterial (bacteriostatic) effect · Interferogenic effect · Immunemodulating effect · Antipruritic effect · Produces rapid effect · Produces no side effect · Prolongs remission · Is absolute rapidly

6. HERPIGEN

Pharmacological peculiarities and mechanism of action. Glycyrrhizic acid is an essential active agent

Mechanism of action:

Glycyrrhizic acid inhibites DNA and RNA of :

· Herpes simplex virus, Varicella –zoster, Hepatitis A virus, Influenza virus, Vesicular stomatitis virus, Human immunodeficiency virus

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VIUSID Clinical StudiesVIUSID Clinical StudiesKenya Medical Research Institute’s Charles Mbakaya, like President Thabo Mbeki, writes Victor Bwire, believes there is a nutrition angle to the Aids pandemic and that is what is guiding his research.

First there was Dr Davy Koech of the Kenya Medical Research Institute (Kemri) and the discovery of Kemron as an Aids drug in 1989. It is no longer heard of. Then came Prof Arthur Obel a decade later. Some say he was designated Chief Government Scientist and his Aids drug was called Pearl Omega. Apart from flouting established scientific research procedures in announcing the drug’s advent, Pearl Omega, too, is rarely heard of these days. But now, there is a new kid on the block with a different approach to the search for an Aids management formula. Charles Mbakaya He is not saying his is the alpha and omega to the Aids pandemic, but like South Africa’s President Thabo Mbeki, he says that Aids is not all about sex. There is the nutrition angle to think about.

It was when reading a copy of the British Journal some 15 years ago, a Kenyan scientist, Charles Mbakaya, made a note that still torments him to this day.

The journal reported that HIV positive people depicted symptoms similar to those in people with a deficiency of zinc in their systems.

Even more important, was the journal’s suggestion that the mineral zinc was essential in the biosynthesis of proteins, production of thymulin and interferon’s which have scientifically proved to be very essential in the human immunity system.

Two years ago, Mbakaya, who is a senior science researcher at the Kenya Medical Research Institute (Kemri), embarked on the long journey for the search of a zinc laden supplement that could help in reducing the viral load in HIV positive people.

“As researcher I developed an interest in the possible role nutrition could play in health promotion, especially in immuno-compromised persons,” says Mbakaya.

“In any case, I have never believed that Aids is singularly a function of sex. Why is it more prevalent in nutrition deprived areas and commonly symp- tomised by loss of weight?” he asks. The Nairobi analytical science graduate then picked on VIUSID - due to its high zinc content - to investigate its possible role in the management of HIV patients in Kenya.

VIUSID is a nutritional preparation specially designed to facilitate the increase of the immunological deficiencies in all body processes that cause immunodeficiency.

The antioxidant substances of VIUSID have the capacity to eliminate the effects of the free radicals that appear in all the infectious processes.

It contains honey, Maleic acid, Glycyrrhizinic acid, Arginine, Glucosamine, Glycine, Ascorbic acid, Pyridoxal, Folic acid Calcium Pantotenate, Zinc Sulphate and Cyanocobalamin.

Through a new technology of molecular activation, the chemical activities of the various ingredients of VIUSID have greatly been enhanced without changing its molecular structure.

It is manufactured by a Spanish company - CATALYSIS Ltd and locally distributed by Management Solutions.

It has been approved and is widely used in 17 African countries. One is advised to take 3 sachets a day for so long as he gets better. A sachet goes for Sh100.

So two years ago, with consent from his employers and assisted by Winfred Kisingu from Kemri and Dr Patrick Orege from the National Aids Control Council (NACC), Mbakaya then started his long journey to the unknown.

Forty four persons from the Association of People Living with Aids (TAPWAK), a national organisation helping HIV positive individuals to live a comfortable and positive life, were chosen for the study.

“During the initial stages of the study, we experienced a lot of problems. Ten people dropped out of the study due to personal problems while four later turned out to be HIV negative on further tests,” Mbakaya says.

The soft spoken Mbakaya says more difficulties were to come as three more died and professional sarcasm from colleagues weighed in with morale as the main target.

Mbakaya says that during a seminar in Zimbabwe, he remembers several scientists dismissing his study.

Many were of the view that the sample size was very small and questioned the rationale of choosing that particular supplement and not others.

In Lesotho during a meeting of scientific researchers, several participants expressed dissatisfaction with Mbakaya’s study.

He remembers one participant saying “That is not a study worthy listening to. The guys spent all the time just observing an uncontrolled objects than deal with a controlled sample.”

But others have been very supportive of the study to the extent that it has started shaping the HIV management agenda on the African Continent.

“Many of the researchers we have shared the results with have expressed their support. They believe that in resource stricken countries, the benefits of our finding far outweigh the long held views on the pandemic,” says Mbakaya.

The results released after 24 months have shown that VIUSID has the capacity to reduce the viral load in HIV positive individuals by over 50 per cent and complete wipe it out sometimes.

Within 3 months of using the supplement, 80 per cent of the patients reported that signs and symptoms associated with HIV such as persistent headaches, night sweats, diarrhoea, itchy skin, rashes and loss of appetite had resolved.

“Some patients even asked if they could be provided with food to match their increased appetites,” Mbakaya says.

Within one year of the study, more than 90 per cent of the patients experienced a significant weight gain, with some gaining as much as 10 kilogrammes.

Additionally, the HIV anti-bodies of the patients almost doubled up within the 24 months of follow-up. This is an indication that their acquired immunity against HIV had been stimulated.

Visible changes start being observed after 7 days of use and in three months of uninterrupted use opportunistic infections disappear.

In 52 per cent of the patients, their viral load reduced by 50 per cent within the study period, with 19 per cent attaining undetectable viral load levels.

Clinically, the VIUSID has no marked side effects. All the patients showed normal liver functions, an indication that it had no toxic effects on the patients.

Mbakaya says that from that, it was clear that it could be used for an extended period of time. “Our study then confirms what other scientists have observed; that micro nutrient zinc may be a critical factor in the transmission and progression of Aids,” Mbakaya emphatically concludes.

The researcher then advises that “nutrition has a critical role in the management of HIV in resource deprived countries such as Kenya.”

Above all, VIUSID has the capacity to reduce the incidence of opportunistic diseases related to HIV, resulting in improved quality of life for the patients.

Additionally, the supplement improves appetite, increases weight and increases patients immunity. Mbakaya, 39, vows not to rest until home-grown solution for Aids are found.

He dismisses the current notion about the transmission of the deadly disease, echoing South African’s President Thabo Mbeki that Africa should not wholly believe the Europeans’ views about HIV/Aids.

“There are other hidden cures for the disease other than the drugs and vaccines being clamoured for,” Mbakaya says.

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Careeganan studies and linksPosit Health News. 1998 Fall;(No 17):4-7. Related Articles, Links

Sulfated polysaccharides (chondroitin sulfate and carrageenan) plus glucosamine sulfate are potent inhibitors of HIV.

Konlee M.

AIDS: Chondroitin sulfate, a fusion inhibitor found in human milk, appears to work by blocking the ability of a virus, such as HIV, to infect a cell. There are questions about whether cow or goat milk can offer the same fusion-inhibiting benefits. One sulfated monosaccharide, glucosamine 6-sulfate, appears to have significant anti-HIV activity. Carrageenan, a seaweed derivative, shows promise as a vaginal microbicide, and should be tested further to determine its effectiveness against HIV transmission.

Publication Types: Newspaper Article

Ecotoxicol Environ Saf. 2000 Mar;45(3):208-27. Related Articles, Links

Anti-HIV activity of extracts and compounds from algae and cyanobacteria.

Schaeffer DJ, Krylov VS.

Department of Veterinary Biosciences, University of Illinois, 2001 South Lincoln Avenue, Urbana, Illinois 61802, USA.

The human immunodeficiency virus (HIV) is the retrovirus that causes the acquired immune deficiency disease syndrome (AIDS). This review discusses the anti-HIV activity of extracts and compounds isolated from freshwater and marine algae, and cyanobacteria (formerly called "blue-green algae"). Compounds and extracts with anti-HIV activity are also active against other retroviruses such as herpes simplex virus (HSV), but the amount of antiviral activity varies with the compound and the virus. Most of the research has focused on sulfated homopolysaccharides and heteropolysaccharides. Sulfoglycolipids, carrageenans, fucoidan, sesquiterpene hydroquinones, and other classes of compounds with anti-HIV activity that have been isolated from algae have received less attention. Most studies have used in vitro test systems, but a few in vivo studies have been carried out using compounds isolated from algae or analogs produced synthetically or isolated from other natural sources. Sulfated homopolysaccharides are more potent than sulfated heteropolysaccharides. The presence of the sulfate group is necessary for anti-HIV activity, and potency increases with the degree of sulfation. Studies using nonsulfated and sulfated homo- and heteropolysaccharides isolated from algae or other natural sources, or synthesized, have revealed the mechanisms of binding of drugs to the virion, and the mechanisms of viral binding to host cells. However, given the few classes of compounds investigated, most of the pharmacopeia of compounds in algae and cyanobacteria with antiretroviral activity is probably not known. Copyright 2000 Academic Press.

Publication Types:

1: Curr Pharm Des. 2004;10(3):315-36. Related Articles, Links

Clinical development of microbicides for the prevention of HIV infection.

D'Cruz OJ, Uckun FM.

Drug Discovery Program, Parker Hughes Institute 2657 Patton Road, St. Paul, Minnesota 55113, USA. odcruz@ih.org

The HIV/AIDS pandemic continues its spread at a rate of over 15,000 new infections every day. Sexual transmission of HIV-1 is the dominant mode of this pandemic spread. For the first time since the disease emerged in the early 1980s, about half the 42 million people now living with HIV/AIDS worldwide are women. Worldwide, more than 90 percent of all adolescent and adult HIV infections have resulted from heterosexual intercourse. The "feminization" of the pandemic largely driven by the social, economic, and biological factors warrants urgent attention particularly for the adolescent female population. In the absence of an effective prophylactic anti-HIV therapy or vaccine, current efforts are aimed at developing intravaginal/intrarectal topical formulations of anti-HIV agents or microbicides to curb the mucosal and perinatal HIV transmission. Microbicides would provide protection by directly inactivating HIV or preventing HIV from attaching, entering or replicating in susceptible target cells as well as dissemination from target cells present in semen or the host cells that line the vaginal/rectal wall. Thus, ideally, anti-HIV microbicides should be capable of attacking HIV from different angles. In addition, a contraceptive microbicide could help prevent unintended pregnancies worldwide. To be a microbicide, these agents must be safe, effective following vaginal or rectal administration, and should cause minimal or no genital symptoms following long-term repeated usage. A safe and efficacious anti-HIV microbicide is not yet available despite the fact that more than 60 candidate agents have been identified to have in vitro activity against HIV, 18 of which have advanced to clinical testing. Targeting HIV entry has been a favored approach because it is the first step in the process of infection and several readily available anionic polymeric products seem to variably interfere with these processes are the primary candidates for potential microbicides. Formulations of some anionic polymeric antiviral agents have been tested at various doses and various durations for safety, tolerability, and acceptability in Phase I/II clinical trials (vaginal, rectal, or penile studies) in HIV-uninfected and/or HIV-infected populations. Current multicenter Phase I/II safety and Phase II/III efficacy studies that are being conducted or planned in different geographical locations by various special interest groups are designed for rapid clinical development of candidate products. The currently marketed detergent-type spermicide, nonoxynol-9 (N-9), has failed in Phase III clinical trials, due to the drug-induced formation of localized genital lesions that might in fact actually promote virus transmission. Alternative "first-generation" microbicides that have undergone Phase I/II safety and tolerability studies in HIV-uninfected and/or HIV-infected volunteers include polymeric viral fusion inhibitors (dextrin sulfate/Emmelle, carrageenans [PC-213, PC-503, PC-515/Carraguard], cellulose sulfate/Ushercell, polystyrene sulfonate, naphthalene sulfonate [PIC 024-4/PRO 2000/5], acidifying gel [Carbomer 974P/BufferGel], Lactobacillus (L. crispatus) suppository/CTV-05, detergent-type dual-function barriers [ACIDFORM, GEDA Plus, SURETE, Glyminox/C31G/Savvy, Invisible Condom], herbal extracts [Praneem], and viral replication inhibitors [PMPA/Tenofovir]. For majority of these products, no information is available regarding their long-term mucosal safety, carcinogenicity potential, bioavailability, or efficacy following their extended vaginal or rectal exposure. The irritative genitourinary symptoms reported for a number of these first-generation products in Phase I clinical trials implies that the "soft" preclinical endpoints for mucosal safety established for the use and development of vaginal spermicides may not be rigorous enough for vaginal and rectal microbicides because of the efficient sexual tra virus diversity, and genetic environment. It is now apparent that sexually transmitted R5 HIV-1 viruses have less positive charge on their surface compared with the R4 HIV-1 viruses, which may limit the anionic polymers as topical microbicides despite extensive clinical trials. Nevertheless, their ongoing clinical trials, reviewed here, using optimized formulations, and special populations in various geographic locations are paving the way for future rigorous clinical testing of "mechanism-based" broad-spectrum anti-HIV microbicides that are currently under intense development. It is anticipated that future microbicide trials will focus on combination of products capable of attacking HIV life cycle at multiple steps intended to increase efficacy, limit cross-resistance as well as minimize microbicide-induced host toxicity.

Publication Types: Review Review, Tutorial

PMID: 14754390 [PubMed - indexed for MEDLINE] info on the bill gates microbiocide is at http://www.popcouncil.org/biomed/carraguard.html

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