Publication:

A study protocol for assessing the efficacy of Shatavaryadi Kashaya and Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause: an open labelled randomized standard-controlled clinical trial

Background Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition in postmenopausal women characterized by genital, sexual and urinary symptoms due to estrogen deficiency. Ayurveda attributes such degenerative symptoms to Vata dominance and Dhatukshaya in Jara Avastha, with management focused on Rasayana and Snehana therapies. This study aims to provide efficacy of oral administration of Shatavaryadi Kashaya along with per vaginal application of Shatavari Ghrita ointment in the management of GSM and to compare it with standard treatment using Multivitamins and Estriol cream.

Methods Open-labelled, randomized, standard-controlled clinical trial, participants, patients fulfilling inclusion criteria of genitourinary syndrome of menopause; interventions: group A will receive Shatavaryadi Kashaya (40 ml orally twice daily) and Shatavari Ghrita ointment (2 gm per vaginal application daily with applicator), while group B received Weltive 4G (oral multivitamin) and Evalon cream (0.5 gm per vaginal application twice weekly) for 60 days. Primary outcome measures include improvements in Vaginal Health Index (VHI), Female Sexual Health Index (FSHI) and urinary tract infection symptoms assessment by UTISA, secondary outcome includes changes in the Vaginal Maturation Index (VMI) measured by Pap smear.

Conclusions This trial aims to assess the potential of Shatavaryadi Kashaya and Shatavari Ghrita ointment as Ayurveda treatment for Genitourinary syndrome of menopause, offering a promising non-hormonal alternative to conventional estrogen therapy. Trial registration: The trial is registered with the Clinical Trials Registry of India (CTRI) CTRI/2025/07/091397.