Efficacy and safety evaluation of Shatavari Gudam and Triphala Kashaya in leucorrhoea (Shwetapradara) – A study protocol of an open-label, multicenter, interventional, single-arm trial

BACKGROUND: In the classical text of Ayurveda, formulations Shatavari Gudam (SG) and Triphala Kashaya (TK) are indicated to treat Shwetapradara. The disease Shwetapradara can be correlated to leucorrhoea based on the similar symptom, painless, white-colored discharge from the vagina. SG is a formulation containing Shatavari (Asparagus racemosus) as a main ingredient. Several studies indicate Shatavari as a tonic for reproductive tract-related diseases. The external use of Triphala has anti-inflammatory, antiseptic, and anti-bacterial actions. The present article is a clinical study protocol on the efficacy and safety evaluation of SG and TK in leucorrhoea (Shwetapradara). MATERIALS AND METHODS: It will be a multicenter, prospective single-arm study planned to be conducted at Regional Ayurveda Research Institute, Thiruvananthapuram, Regional Ayurveda Research Institute Nagpur, National Ayurveda Research Institute for Panchakarma, Cheruturthy and Regional Ayurveda Research Institute Vijayawada. One hundred sixty participants will be recruited for the trial (40 from each center). In the dose of 6gm, SG will be administered twice daily with lukewarm water after food. Vaginal douche will be done with TK for seven days in two consecutive cycles. The primary outcome will be change in the quantity of white discharge using visual analog scale. The secondary outcome will be change in other associated symptoms like pruritis vulva, lower abdominal pain, low back ache, burning micturition, and dyspareunia using the Visual Analogue Scale; change in the Quality of life and well-being by PGWBI score; change in Score of Investigator’s Global Satisfaction Scale, and changes in Patient’s Global Satisfaction Scale from baseline to final visit. Clinical/biochemical assessments will determine the safety and tolerability of the formulation during the follow-ups. Compared with the baseline, the efficacy of interventions on the 84th and 98th day, will be assessed with Paired t-test. Data will be analyzed using SPSS 15.0 software. ETHICS AND DISSEMINATION: The IEC clearance has been obtained from each participating institute. After completion of the trial, the outcome will be disseminated through peer-reviewed journals for publication.