| CTRI Number |
CTRI/2024/04/065920 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Tila Tail and Shatavaryadi Ghrita in the Management of Menopausal Syndrome. |
|
Scientific Title of Study
|
A Clinical Study of effect of Tila Tail Yoni Pichu and oral use of Shatavaryadi Ghrita in the Management of Rajonivrittijanya Lakshan with special reference to Menopausal Syndrome. |
| 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 Shivani Gupta |
| Designation |
MS Scholar Prasuti tantra Evum Stri Roga |
| Affiliation |
Government Ayurvedic PG College and Hospital Chaukaghat Varanasi |
| Address |
Department of Prasuti tantra Evum Stri Roga
Government Ayurvedic PG College and Hospital Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8630002635 |
| Fax |
|
| Email |
guptashivani3112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarika Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic PG College and Hospital Chaukaghat Varanasi |
| Address |
Department of Prasuti tantra Evum Stri Roga
Government Ayurvedic PG College and Hospital Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8707624954 |
| Fax |
|
| Email |
sarikasri2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Gupta |
| Designation |
MS Scholar Prasuti Tantra Evum Stri Roga |
| Affiliation |
Government Ayurvedic PG College and Hospital Chaukaghat Varanasi |
| Address |
Department of Prasuti tantra Evum Stri Roga
Government Ayurvedic College Chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8630002635 |
| Fax |
|
| Email |
guptashivani3112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurvedic College and Hospital Chaukaghat Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and Hospital Chaukaghat Varanasi |
| Address |
Department of Prasuti Tantra Evum Stri Roga
Government PG Ayurvedic College and Hospital Chaukaghat Varanasi |
| Type of Sponsor |
Government 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 Sarika Srivastava |
Government PG Ayurvedic College and Hospital Varanasi Uttar Pradesh |
Department of
Prasuti Tantra and Stri Roga
OPD number 1 & 36
Varanasi
UTTAR PRADESH |
8707624954
sarikasri2k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government PG Ayurvedic College and Hospital Varanasi Uttar Pradesh Sampurnanand Sanskrit University Varanasi Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi Ghrita , Reference: A.S.U 39/31, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm milk ), Additional Information: -not applicable | | 2 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: B. P. C 70/37, Procedure details: Till urge of urination after applying once a day )
(1) Medicine Name: Tila Tail , Reference: Su.su 45/113, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient willing for trial
2. Female with age 40-55 years
3. Patient have no malignant changes on pap smear
4. Patient have no any chronic systemic illnesses
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing for trial
2. Women with age below 40 years and above 55 years
3. Patient with malignant changes on pap smear
4. Women with medical conditions like Diabetes mellitus,hypertension, cancer treatment and HRT
5. Women on OCPs (oral contraceptive pills)
6. Patient with acute pelvic inflammatory disease 7. Patient with acute urinary tract infections
8. Patient with any genital growth
9. Pregnant and Breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Menopausal symptoms |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in general conditions |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1 STUDY OF RAJONIVRITTI JANYA LAKSHAN IN MENOPAUSAL
WOMEN ACCORDING TO AYURVEDA published in WJPR on 11/04/2024
2 A CASE STUDY TO KNOW THE EFFECT OF SHATAVARYADI GHRITA AND TILA TAIL ON THE MENOPAUSAL SYMPTOMS published in IJCRM on march 2025 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Interventional study
Patient suffering from Menopausal Syndrome will be selected from OPD and IPD of Department of Prasuti Tantra Evum Stri Roga Government PG Ayurvedic College and Hospital Chaukaghat Varanasi.
Total patient - 60
Treatment plan - Gp A- 30 patients who will be given trial of Tila tail yoni pichu for 7 days and oral use of Shatavaryadi ghrita 10 gm per day with luke warm milk for 3 months Gp B - 30 patients of control group who will be given trial of Tila tail yoni pichu for 7 days at interval of one month in 3 consecutive months Duration of trial- 7 days in each month for 3 consecutive months
Follow up - after 1 month of each trial for 3 consecutive months |