Study Protocol for a Yoga-Based Lifestyle Modification Program for Leucorrhea Disorders

Leucorrhoea is natural vaginal discharge caused by hormonal changes, pregnancy, or sexual stimulation. This study protocol describes the methodology for a 12-week yoga program on the symptoms of leucorrhoea disorder among adult females.

The present study is a two-armed, randomized parallel-group, active-control trial for patients with blinded outcome assessors and multiple primary and secondary outcomes. The appropriate sample size will be determined based on the findings of the feasibility study. The participants will be recruited from a hospital and research centre in Madhya Pradesh, India. Individuals who meet the inclusion criteria for leucorrhoea disorder will be chosen following laboratory examinations. Randomization will be used to assign the chosen individuals to either the intervention or control groups (1:1). For adult females with leucorrhoea disorders, the intervention will consist of a yoga-based program that will run for one hour, five days a week, for 12 weeks. Data will be collected at baseline and post-intervention, in the 12th week. The outcome measures will include various primary (colour, odour, amount, vaginal culture, vaginal smear, and imbalance of various gonad hormones) and secondary (lower abdominal pain and quality of life) outcomes. The analysis will involve intention-to-treat and per-protocol approaches that will evaluate the impact of yoga on various outcome measures and will be assessed using statistical tests.

The study has been approved by the Institution Ethics Committee of Lakshmibai National Institute of Physical Education. Written informed consent will be obtained from each participant before inclusion. Results will be available through research articles and conferences. The summary of key results in layman's language will be made publicly available through newspaper articles.