A double-blind randomized clinical trial of novel Ayurvedic muco-adhesive extended release vaginal tablet (NA) for treatment of leucorrhea

Abstract

Leucorrhea or vaginitis could be primarily caused by yeast infections, bacterial vaginosis or Trichomoniasis. The hydro-alcoholic extract of a novel vaginal herbal formulation was prepared by adding dried stems of Azadirachta indica A. Juss. and Saraca asoca Roxb., mentioned in Ayurvedic text Charak Samhita for treatment of excessive vaginal discharge. Pre-clinical studies revealed antimicrobial action, no toxicity, presence of phenolic compounds and sustained drug release pattern for this muco-adhesive vaginal tablet. This double-blind randomized clinical study was done on 363 females equally divided into the placebo, standard drug, and four research drug groups for 15 days. Subjective primary and secondary symptoms as well as objective biochemical parameters and vaginal fluid were analyzed before and after treatment. Results of clinical study indicate that all four research drug groups exhibited comparable and sometimes better therapeutic efficacy compared to standard drug. The research formulation resulted in 80-90% inhibition of subjective symptoms and demonstrated strong and significant (p < 0.05) antimicrobial action validating its high therapeutic efficacy.