The Delhi based leading research institute, Indian Council of Medical Research (ICMR), has successfully completed its phase II clinical trial on Praneem at National AIDS Research Institute (NARI), Pune. It is a gel, based on neem microbicide, which helps to women in preventing the transmission of HIV/AIDS infections. The company is planning to commence phase III trial shortly at various centres.
Vaginal microbicides can be used to prevent HIV infection and other sexually transmitted diseases (STDs). Over 60 products are currently being evaluated as possible microbicides and are in various stages of clinical development. Praneem polyherbal tablet is one such product, indigenously developed in India. It contains purified extract of Azadirachta indica (Neem) along with purified Saponins from Sapindus mukerosi and Mentha citrata oil with sodium alginate as an excepient.
In an interaction with Pharmabiz, Namita Chandhok, deputy director general of Indian Council of Medical Research, said, "We have efficiently completed our phase II trial of Praneem drug at National AIDS Research Institute (NARI), Pune. We have taken nearly 2000 women for phase II study. During phase II clinical trial, we have identified 50 high risks, but HIV negative women, who used it regularly for six months and we are pleased with the results. Now we are planning to go for phase III clinical trial, which is expected to begin shortly at multi centres. The final results are expected in around 18 months time".
Microbicide is a compound with the ability to defend against sexually transmitted diseases. During the time of pre clinical trial researchers have recorded Praneem's toxicological effects.
Talking about other initiative Chandhok, said, "We are also carrying out one more study for the same preventive healthcare segment. Another product is Basant, which is curcuma based microbicide. For the Basant, we are planning to commence phase I clinical trail at Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. We will take 300 women for the trial and trial will run for 14 days".