| CTRI Number |
CTRI/2026/04/107332 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
16/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing two Ayurvedic treatments (pessary and pichu) for vaginal dryness in women aged 40–50 years. |
Scientific Title of Study
Modification(s)
|
A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SHATAVARI GHRITA VAGINAL PESSARY WITH SHATAVARI GHRITA YONI PICHU IN THE MANAGEMENT OF PERIMENOPAUSAL TO POSTMENOPAUSAL VAGINAL DRYNESS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohini Kute |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved vadodara |
| Address |
OPD No-104, Department of PTSR, Parul Ayurved Hospital
Parul Institute of Ayurved vadodara,Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
07057052214 |
| Fax |
|
| Email |
mgkute98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thulasi V S |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved vadodara |
| Address |
OPD No-104, Department of PTSR, Parul Ayurved Hospital
Parul Institute of Ayurved vadodara,Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
07057052214 |
| Fax |
|
| Email |
mgkute98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohini Kute |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved vadodara |
| Address |
OPD No-104, Department of PTSR, Parul Ayurved Hospital
Parul Institute of Ayurved vadodara,Gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
07057052214 |
| Fax |
|
| Email |
mgkute98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University Limda Waghodiya Vadodara- 391670 Gujrat |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohini Kute |
OPD No-104, Department of PTSR, Parul Ayurved Hospital |
Parul Institute of Ayurved,Parul University Limda Waghodiya Vadodara Gujrat
Vadodara
GUJARAT |
07057052214
mgkute98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni pUraNa , योनि पूरण | (Procedure Reference: Bhaishajya Ratnavali (Yonivyapad Chikitsa, 69/20–23, Procedure details: Yoni Pichu with Shatavari Ghrita (approximately 5 ml) will be inserted intravaginally & retained for about 2 hours daily for 14 days.)
| | 2 | Comparator Arm | Procedure | - | yoni pUraNa , योनि पूरण | (Procedure Reference: Bhaishajya Ratnavali (Yonivyapad Chikitsa, 69/20–23, Procedure details: Shatavari Ghrita vaginal pessary will be inserted once daily at bedtime for 14 days.)
|
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Perimenopausal to Postmenopausal women aged 40 to 60 years.
Women diagnosed with vaginal dryness based on clinical evaluation
Women who are willing to participate and give informed written consent.
Not undergoing any concurrent hormonal replacement therapy, vaginal estrogen, or herbal therapy.
|
|
| ExclusionCriteria |
| Details |
Women with active vaginal infections or cervical lesions.
Presence of pelvic organ prolapse.
Use of hormonal replacement therapy, vaginal estrogen, or other local hormonal treatments.
Known allergy or hypersensitivity to Shatavari or Ghrita.
Diagnosed cases of pelvic inflammatory disease, endometriosis, or gynecological malignancies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in vaginal dryness assessed by Visual Analogue Scale-VAS |
Day 0, 8, 14 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change in Vaginal Health Index Score VHIS
Timepoints
Baseline Day 0 & Day 8
Change in vaginal pH
Timepoints
Baseline Day 0 & Day 8
Reduction in associated symptoms itching, burning sensation, dyspareunia assessed by Visual Analogue Scale VAS |
day 0,8,14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perimenopause is a transitional phase in women commonly associated with symptoms such as vaginal dryness, itching, burning sensation, and dyspareunia due to declining estrogen levels. These symptoms can significantly affect quality of life. In Ayurveda, local therapies such as Yoni Pichu are traditionally used to manage vaginal disorders. The present study aims to evaluate and compare the clinical efficacy of Shatavari Ghrita vaginal pessary and Shatavari Ghrita Yoni Pichu in the management of vaginal dryness in perimenopausal women aged 40–50 years. A total of 60 eligible participants will be randomly allocated into two groups. Clinical outcomes will be assessed using the Visual Analogue Scale (VAS), Vaginal Health Index Score (VHIS), and vaginal pH before and after treatment. The study may help determine an effective, safe, and acceptable non-hormonal Ayurvedic management for perimenopausal vaginal dryness. |