Objective – The objective of the study was to evaluate efficacy of an Ayurvedic Formulation – Somha Tablets in females suffering from non-specific leucorrhoea.
Materials & Method – The study was an open label, non-comparative, single centre, retrospective, interventional clinical study. A total of 120 female patients between the age of 20-45 years having complaints of excessive vaginal discharge on Non-Period days causing discomfort with or without associated symptoms like Vaginal/Vulval itching, foul smell and low back/abdominal pain were recruited in the study. Participants were advised to take proprietary marketed product viz. Somha Tablets containing ingredients like Lodhra, Shatavari, Daruharidra, Guduchi etc. in a dose of 2 tablets twice daily with water for 60 days. Follow up was done at 15 days interval to assess change in symptoms associated with leucorrhoea (Itching, Foul smell, wetting of garments, Lower abdominal pain, Low back ache, Pruritus vulva, Genital ulceration, Burning micturition), Vaginal discharge and nature of discharge. Participants having any serious abnormalities were excluded from the study.
Results – Female participants of average age 26.52 ± 5.46 complaining of non-specific excessive vaginal discharge over a period of 45.44 ± 10.80 days were recruited. A total of 95/120 participants reported of complete recovery from excessive discharge and associated symptoms at the end of 60 days of study. The mean score of vaginal discharge was 2.06 ±0.25 at baseline, which reduced to 1.30 ±0.43 (p<0.05) at the end of 30 days and further to 0.52 ±0.51 (p<0.05) at the end of 60 days. The mean score of nature of vaginal discharge was 3.16 ±0.83, which reduced to 1.13 ± 0.73 (p<0.05) at the end of 30 days and further to 0.45 ±0.13 (p<0.05) at the end of 60 days. Other associated symptoms like itching, abdominal pain/backache and foul smelling also showed significant reduction with 60 days use of Soma Tablets. None of the participants showed worsening in their condition. No adverse drug reaction was observed and the study products were well tolerated.
Conclusion- Ayurvedic tablets (Somha) was found to be effective in significantly reducing excessive vaginal discharge (non-specific) and its associated symptoms. The product was also found to be safe without causing any adverse effects.
Keywords – Non Specific Vaginal Discharge, Somha Tablets