FIAR Director's Report - 2004
Currently, Gandeepam has been using a formula consisting of some 27 herbs (Main Formula). All new patients receive this, usually as a fresh juice. (It can also be provided as a powder or in capsules, however these are not as thought to be as potent as the fresh juice.) In addition, the patient's clinical condition is evaluated and recorded. They may then be given additional treatment (in the form of combinations of botanicals, minerals and other Siddha medicines) to a) strengthen immune responses and b) manage and diminish opportunistic or other infections.
Dr. Ramani has informed us that the Main Formula is being evaluated for medical licensure by companies in both Tamil Nadu and in Andhra Pradesh. This is in preparation for also submitting an application for a patent to protect their intellectual property rights (a key feature of this grant).
The majority of HIV+ patients are being treated at their site in Namakkal. There are other clinic sites (besides the main garden in Sivagangai District) located in Pudukkotai and Bangalore (just opened). At the Namakkal site, there are two physicians and five outreach workers. The outreach workers does outreach to nearby villages; each of the five covers 5-7 villages (approximately 30 villages), and patients are followed-up during these visits. In addition, awareness of the project is sustained.
At this point, we also developed the concept for an intensive review of some 30 new patients. The primary aim is to assure the safety of the interventions Gandeepam is using. In addition, this open label evaluation will underscore Gandeepam's capacity to document, monitor, follow up and develop/maintain inclusion/exclusion criteria for a clinical study. In addition, all efforts to assure patient safety and informed consent will be undertaken, as per the improvement upon the current informed consent as well as the utilization of the relevant IRBs (at Gandeepam and Mt. Sinai). Finally, patient records are kept in a locked room. A file cabinet with a lock will be obtained to further assure patient confidentiality. The current informed consent they have been using is being reviewed and strengthened. In addition, practitioners have already developed a simple unique identifier system to follow patients. This effort will also be further evaluated.
Such a study should enroll rapidly. They see approximately 8-15 new patients per week. Very often, the patients arrive on Sunday. One Sunday, 30 people showed up! It is anticipated that the 30 individuals who will receive intensive review may be recruited within three weeks. Field staff may be utilized if there is a particularly heavy Sunday that enrolls a large batch to catch any information that may be missed if there should be a particularly heavy patient load day.
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