Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bengaluru, which evaluated the safety and efficacy of a poly-herbal formulation (PHF) in the treatment of HIV/AIDS, has found it was safe for human administration.
The project was funded by the Department of Science and Technology (DST), JNCASR which has a dedicated HIV/AIDS laboratory, collaborated with an NGO Samraksha, Bengaluru and several hospitals that specialize in HIV management including the Seva Free Clinic; Chest and Maternity Centre, National Institute of Mental Health and Neuro Sciences (NIMHANS), Shanmugha Arts, Science, Technology and Research Academy (SASTRA), Thanjavur; All India Institute of Medical Sciences (AIIMS), New Delhi.
The herbal formulation, manufactured by Vedic Drugs Pvt. Ltd., Bengaluru, consists of ingredients from 58 different plant species and sans heavy metals. In a prospective, open-label, non-randomized clinical trial, 32 subjects were administered the herbal formulation orally for four months and followed up for two years. For comparison, 31 other subjects under the standard antiretroviral therapy (ART) were observed for the same period.
All the subjects were HIV-1 positive and did not take anti-HIV medicines previously. Their CD4+ count was 200 and 250 cells and they lacked presenting opportunistic infections. The trial subjects’ blood parameters and AIDS-related clinical symptoms were monitored at three-month intervals using standard techniques. The controlled, investigator-blinded trial was registered with the Clinical Trials Registry of India, CTRI/2008/091/000021.
“Collectively, our results indicate that the poly-herbal formulation may have provided protection by slowing the loss of CD4 cells in the blood. In the absence of a potential therapeutic vaccine for HIV/AIDS and given the various limitations characteristic of the anti-retroviral therapies, the identification of a potential ‘immunomodulator’ to control HIV-AIDS is of paramount importance,” said Dr Udaykumar Ranga, professor, Molecular Virology Laboratory of the Molecular Biology Unit, JNCASR.
“The trial generated high quality data from the meticulous study design. Inferences drawn from this study are supported by a large number of repeat observations from each participant. Monitoring the AIDS-related illnesses added strength to the present study. The progress of the study was monitored by the NGO and its Institutional Ethics Committee, but not by the study investigators, thus guarding against any possible vested interests,” said Dr Ranga.
This research is published in The Indian Journal of Medical Research titled as ‘Evident stabilization of the clinical profile in HIV/AIDS.
“In spite of the encouraging results, under no circumstances, the poly-herbal formulation evaluated in the present clinical trial must be considered a ‘drug’ for HIV-AIDS. The experimental data is only indicative but not assertive of the beneficial effects. This is because our study was only a pilot clinical trial, not a randomized, multi-centric and placebo-controlled large-scale clinical trial, said Dr Ranga.
“The intrinsic limitations of the study design, that were unavoidable due to practical and ethical considerations, do not permit drawing an assertive inference from the data. Despite these limitations, the study generated high quality data and offered potential leads. The beneficial effects, however, must be confirmed in future clinical trials that are rigorous and uncompromising in study design,” said Dr Ranga.
“Now the only way to confirm our results is to conduct a larger and rigorous clinical trial which was an expensive proposition. However our trial collectively offers key novel ways to HIV management,” said Dr Ranga.