Summary statement of proceedings on 25th and 26th November, 2004.

On Thursday 25 of November 2004 a group including representatives of the Gandeepam. Non Governmental Organization led by vaidhyar. Ramani, scientists nominated by the ICMR and clinical research specialists from France met, under the Chairmanship of professor BN Dhawan and Dr. Marc Lallemant to examine the data presented by Gandeepam on the use of the "Siddha medicine" for the treatment of condition that Gandeepam healers consider to be equivalent to "AIDS in the biomedicine classification of Diseases.

Gandeepam practitioners reported that use of Gandeepam formulation effected disappearance of symptoms with in an approximate period of 3 months. In almost all of the hiv positive (serologically) 100 patients who sought Siddha care in Gandeepam according to Gandeepam practitioners, these patients remained symptom free after their treatment was stopped. The Modern Medicine or Biomedicine experts presented a general overview of the methodological complexities and regulatory constraints of evaluating therapeutic interventions. As well as the methodology for identifying potentially active components of the traditional preparations such as those used in siddha medicine. The monitoring and evaluation of such that's was equally important for the successfully completion of a trail.

The consensus among participating scientific was that the evaluation of the Gandeepam Siddha therapeutic approach to "AIDS" as defined within the Modern Medicine/ Biomedicine system should use the validated methodologies of clinical trails, which include

1. Formal conception of an investigation plan (written protocol).
2. Observance of good clinical practices.
3. Ethical clearance by appropriate research ethic committees
4. Informed consent of patients to participate in research.
5. Access to the currently available treatment of HIV/AIDS of established efficacy (including     antiretroviral therapy and anti-infectious agents for the treatment and prevention of     opportunistic infections)

An this stage, the experts agreed that more work was required to establish the safety and efficacy of Gandeepam Siddha in HIV/AIDS "This may be due to different terminologies used in the traditional and Modern Medicine Systems for diseases where in Siddha Medicine symptoms of HIV suggested group of disorders under the term "Mega Vettai" The unspecified nature and modalities of the Gandeepam therapeutic intervention, and the difficulties in interpreting the Siddha outcomes of the intervention in biomedical terms the order facts to be considered while designing the trail protocol.

It was therefore the recommendation of the group of proceed with the formal evaluation of the Siddha therapeutic approach to AIDS by a competent clinical research team of methodological , physicians from both Siddha and HIV medicine, biologists and statisticians, all working in close collaboration with Gandeepam practitioners.

While safety must be of prime concern, several clinical trail design options mat be shed light in to the putative efficacy of the Siddha medicine. The design of such focused trails depends on the primary questions that researchers may what to address for example, 1) Can the Siddha intervention" delay the progression of HIV infected patients to AIDS / immunosuppression thus sparing the use of antiretroviral drugs for a certain amount of time. 2) Can the "siddha intervention" enhance the immunological or virological activity of antiretroviral drugs or speed up patients "clinical recovery "? Does it diminish /alleviate the side effects or toxicities of antiretroviral therapy? 3) Can Siddha approach even be an alternative to the use antiretroviral therapy of HIV/AIDS? 4) what could be the potentially active ingredients of Gandeepam's Siddha preparations should be examined separately .

In addition the group considered that it may be advisable for trail design purpose to obtain preliminary data in well designed and monitored observational study of minimally immuno-compromised patients. Which would evaluate the potential activity of Gandeepam Siddha preparation on virus replication on the patients immune status. The data of the 100 patients who were administered the Gandeepam formulation be examined by NIE to determine the sample size for such as study since there is a great sense of urgently to validate the safety and efficacy of Siddha medicine to treat AIDS patients at a time when access to antiretroviral drugs of proven efficacy is scaling up worldwide.