| CTRI Number |
CTRI/2026/01/101994 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of local ayurvedic therapy in the management of genitourinary syndrome of menopause |
|
Scientific Title of Study
|
Effect of sthanika chikitsa In Genitourinary Syndrome of Menopause |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sripriya J R |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Sreebhadra Chithirampazhanji Athiyannoor Aralummood P O
Thiruvananthapuram
KERALA
695123
India |
| Phone |
8891479880 |
| Fax |
|
| Email |
sripriyanta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sripriya J R |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Sreebhadra Chithirampazhanji Athiyannoor Aralummood P O
Thiruvananthapuram
KERALA
695123
India |
| Phone |
8891479880 |
| Fax |
|
| Email |
sripriyanta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Thomas |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda college Thrippunithura |
| Address |
Govt Ayurveda College Trippunithura
Ernakulam
KERALA
682301
India |
| Phone |
9446485655 |
| Fax |
|
| Email |
gibysusanadr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sripriya J R |
| Address |
Govt Ayurveda College Thiruvananthapuram |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Sripriya J R |
Govt Ayurveda College Hospital For Women and Children,Poojapura,TTrivandrum |
Govt Ayurveda college hospital for women and children Poojapura
Thiruvananthapuram
KERALA |
8891479880
sripriyanta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committe,Govt Ayurveda college Trivandrum |
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 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charaka samhitha, Procedure details: Thriphala Kashaya kshalana for 7 days & for 2 consecutive months )
(1) Medicine Name: Thriphala, Reference: Charaka samhitha, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Charaka samhitha, Procedure details: Vaginal Tampon soaked in Vallabha taila for 7 days & for 2 consecutive months)
(1) Medicine Name: Vallabha taila, Reference: Kuchumara Tantra, Route: Vaginal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Symptoms of Genito Urinary Syndrome of Menopause are included |
|
| ExclusionCriteria |
| Details |
Uncontrolled DM,HTN,other diseases and Malignancies are excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Symptoms of Vaginal Dryness Dyspareunia Burning sensation and Dysuria |
On 0th day
61stday and
91 st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Vaginal epithelium and Vaginal pH |
0th day and 61 st day |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2027 |
| 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) |
Open to Recruitment |
|
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
|
This a pre and post interventional study with a sample size of 23 who are females with age group of 45-55years who have attained menopause having any two of the following symptoms ie, vaginal dryness, burning sensation in vagina, dyspareunia and dysuria attending Prasutitantra and Streeroga OPD of Government Ayurveda College, Thiruvananthapuram are taken for study. Participants are allocated consecutively selected as per inclusion and exclusion criteria. Yonikshalanam with Triphala kashaya 500ml and YoniPichu with Vallabha thaila 30ml as Sthanika Chikitsa for 7 days at an interval of 30 days for 2 consecutive months and 1 month followup will be given for participants. Patient will be advised to report on 31 day and 61ª day during study period and 91 day for followup |