Phase i and Ii clinical trials with Vicoa Indica (Banjauri) , a herbal medicine, as an antifertility agent
Dhall, K.; Dogra, M.
Contraception 37(1): 75-84
1988
ISSN/ISBN: 0010-7824 PMID: 3365984 DOI: 10.1016/0010-7824(88)90150-3Document Number: 351167
Vicoa Indica, a plant belonging to the family Compositae is used by Adivasies (tribal population) in Bihar state of India to produce sterility. The plant is locally known as Banjauri which literally means an agent which makes a woman sterile when administered for 3 consecutive days immediately after delivery. It is believed that this plant prevents conception for periods as long as 5-7 years. Sometimes it is also taken during menstrual cycles, the effect of which is variable. Banjauri had been subjected to antifertility studies in female albino rats and was found to be more effective when given postpartum than when administered during early pregnancy. The preclinical toxicity study carried out in 2 rodent species, albino rats and albino rabbits, did not show abnormal changes in the various biochemical, hematological and histopathological parameters, when the drug was administered at 7 times the human dose for 3-6 weeks duration. In this study, the safety and contraceptive efficacy of Vicoa Indica has been evaluated in female subjects for the 1st time by using modern methods of a clinical trial. The drug, when administered in a dose of 15 gm once a day for 3 days for 3 cycles, was found to be free from side effects and possessed antifertility activity which is dose-related and can be improved upon by modifying the drug delivery system.