This was a prospective, randomized, double blind, placebo controlled comparative trial carried out in the AIDS counseling center of Skin and Venereal diseases department of Government Medical College Hospital, Nagpur with permission from Institutional Ethics Committee. Patients diagnosed to be HIV positive were approached with the request to participate in this trial. Those who showed interest were given detailed information handouts about the trial, in the language understood by them. From those who volunteered to participate, informed witnessed written consent was taken. The inclusion and exclusion criteria were:
- Subjects diagnosed to be HIV positive
- Attending the HIV counseling center of GMCHN
- Volunteering to participate and give informed written consent
- Of either gender in the age group of 18 - 50 years.
- Patients on ART
- Taking immunomodulators
- Suffering from associated diseases like hypertension, ischemic heart disease, diabetes, or CNS disorders.
- Clinical evidence of end organ damage
- Pregnant or lactating women
- Participation in any medicine trial in previous one month.
Baseline pulse, respiratory rate, blood pressure and temperature were recorded. After clinical examination, 68 participants were entered in the trial. They were randomly assigned to two groups of 34 each to receive either coded TCE 300 mg per tablet or matching placebo in the same formulation, packing, size, weight, color and dose of one tablet three times a day for six months. Baseline TLC, DLC, ESR, platelet count, hemoglobin and CD4 count were done.
The medicines were issued to the participants for one month at a time and refill was given during monthly recall. During recall the participants were asked to bring the leftover medicines along with the container. 80% drug consumption was considered to be compliant. All the returned medicines were discarded. At each monthly visit the patients were asked to report the occurrence of fever, cough, easy fatigability, arthralgia, oral ulcers, diarrhea, skin rash or any other symptom. The participants were at liberty to withdraw from the trial at any time. The participants were explained to take treatment whenever necessary, for minor complaints like fever, diarrhea, skin diseases, pain and also for other infections like tuberculosis.
The TLC, DLC, ESR, platelet count, Hb% were repeated at bimonthly intervals. CD4 count was repeated at the end of the study. The trial medicines were decoded at the end of the trial and the participants were followed up for additional one month for monitoring the residual effects, if any. Institutional ADR monitoring and reporting system was followed. All data was logged in the case record form by principal investigator. The results were analyzed by Kruskal Wallis test.
M/s Pharmanza India Ltd, Gujarat, India supplied the TCE (Tinofend R) and matching placebo, free of cost, on our request. Each tablet of Tinofend contained 300 mg of standardized extract obtained from water extract of stem of TC. It contained more than 5% bitter principles and was tested for presence of cordioside and tinosporoside by HPLC.