Research to evaluate efficacy of Shatavaryadi Kashaya orally along with per vaginal application of Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause and to compare its efficacy with standard treatment

Efficacy of Shatavaryadi Kashaya along with Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause - an open labelled randomised standard control clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091397

Enrollment

Registered

2025-07-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N952- Postmenopausal atrophic vaginitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Postmenopausal women (equal or more than 12 consecutive months since last menstrual period) 2.Age 40-65 years 3.Presence of at least 3 common symptoms of GSM i.e. Yoniraukshya, Yonikandu, Mutrakruccha, Mutradaha, Yonivedana, Yonidaha (vaginal dryness, vaginal itching, dysuria, burning micturition, dyspareunia, burning sensation per vagina). 4.Women with a confirmed diagnosis of menopause (natural- absence of menstruation for 12 months or more than that) or surgical- A history of bilateral oophorectomy or hysterectomy with or without bilateral salpingo-oophorectomy) 5.Willing to provide informed consent and comply with study protocol

Exclusion criteria

Exclusion criteria: 1.Women under 40 or over 65 years of age. 2.Premenopausal women or those with irregular menstrual cycles. 3.Current use of systemic hormone replacement therapy (HRT) or vaginal estrogen treatments. 4.Active vaginal or severe urinary tract infections associated with fever, chills. 5.History of cervical, ovarian, endometrial, vaginal, vulvar and breast cancer. 6.Severe pelvic organ prolapses or other gynecological disorders requiring surgical intervention. 7.Current use of medications that affect sexual function or vaginal health(e.g,certain antidepressants, antihistamines). 8.Subjects with uncontrolled HTN (Blood Pressure equal or more than 150/100 mm of Hg) and Diabetes (RBS equal or more than 200 mg/dl)

Design outcomes

Primary

Measure	Time frame
Reduction in the symptoms of Genitourinary Syndrome of Menopause (GSM), measured by standardized symptom scoring tools -Vaginal Health Index (VHI), Female Sexual Health Index (FSHI), Urinary tract infection symptoms assessment (UTISA)Timepoint: 60 Days	—

Secondary

Measure	Time frame
Changes in the vaginal maturity Index. Improvement in Quality of life of postmenopausal women. Timepoint: 60 days	—

Countries

India

Contacts

Public ContactProf Shilpa Donga

ITRA,Jamnagar

drshilpadonga@yahoo.com9825646796

Outcome results