Efficacy of Kasisadi gel; Modified dosage form of Ayurvedic topical applicant in vulvovaginitis – A comparative randomized standard controlled clinical trial

Background: Kaphaja Yonivyapada (vulvovaginitis) is one among twenty types of Yoniroga (gynaecological disorders) caused by vitiation of Kapha with active involvement of Vata Dosha . Yonigata Pichhilasrava (unctuous vaginal discharge), Yonikandu (vulvovaginal itching), and Yonigata-Vedana (vulvovaginal pain) are the cardinal features of Kaphaja Yonivyapada and vulvovaginitis. The formulation Kasisadi Gel (KG), a modified form of Kasisadi Varti described by Acharya Charak in the treatment of Pichhila Yoni, contains multiple herbs and provides total care by producing antiseptic, decongestant, immunomodulatory, and anti-inflammatory properties, which provide relief in the symptoms of vulvovaginitis. Aims: To evaluate the efficacy of KG in the management of Kaphaja Yonivyapad vis-a-vis vulvo-vaginitis. Materials and methods: An open-label randomized controlled clinical trial was conducted in sixty married women suffering from Kaphaja Yonivyapada of the age group of 20–40 years. After confirming the clinical and microbiological diagnosis, patients were randomly divided into two groups: Group A ( n = 30) received KG for local application and group B ( n = 30) received a market product. Both interventions were applied locally in the vagina (2 g) for 7 days and thereafter subjects were followed up for the next 7 days. Assessments were done at baseline, 7 th and 14 th days. Primary outcome measure was relief in symptoms of vulvovaginitis and secondary outcome measure was reduction in pathogenic bacteria both Gram-positive and Gram-negative. Results: After applying proper statistical test (one-way analysis of variance test, Tuke’s multiple comparison test), it is found that both KG and market product provided the significant improvements. However, Kasiadi Gel was better compared to market product in terms of primary and secondary outcomes. Comparison of outcomes from baseline on the 14 th day showed significant improvement in both the groups in parameters such as abnormal vaginal discharge, vulvovaginal itching and vulvovaginal pain and vaginal pH. Conclusion: This study is overly concluded that the KG is highly effective in reducing the clinical sign and symptoms of Kaphaja Yonivyapad (vulvovaginitis).