| CTRI Number |
CTRI/2026/02/104322 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Shatavari Kalpa and Shatpushpa Kalpa with Vaginal Gel in Reducing Perimenopausal Symptoms and Improving Antioxidant Levels. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Shatavari Kalpa with Vaginal Gel and Shatpushpa Kalpa with Vaginal Gel in Managing Perimenopausal Symptoms with Reference to Oxidative Stress. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Soni Kapil |
| Designation |
HOD Professor Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Kangra H.P. |
| Address |
Department of PTSR room no. 203 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P.
Department of PTSR room no. 203 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Soni Kapil |
| Designation |
HOD Professor Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Kangra H.P. |
| Address |
Department of PTSR room no. 203 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P.
Department of PTSR room no. 203 Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P.
HIMACHAL PRADESH
176115
India |
| Phone |
09418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanuja Kanwar |
| Designation |
PG Research Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola Kangra H.P. |
| Address |
Dhanvantri Girls Hostel Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra
Dhanvantri Girls Hostel Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08988062218 |
| Fax |
|
| Email |
t.kanwar.23@gmail.com |
|
|
Source of Monetary or Material Support
|
| HP charak pharmacy, rajiv gandhi government post graduate ayurvedic college and hospital paprola distt kangra baijnath himachal pradesh 176115 india |
|
|
Primary Sponsor
|
| Name |
Government of Himachal Pradesh |
| Address |
HP Secretariat Shimla 171002 |
| 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 |
| Prof Soni Kapil |
RAJIV GANDHI GOVT. POSTGRADUATE AYURVEDIC COLLEGE & HOSPITAL PAPROLA DISTT KANGRA H.P 176115 |
OPD and IPD Department of Prasuti Tantra Evum Stree Roga Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra H.P.
Kangra
HIMACHAL PRADESH |
09418499799
skbhardwaj73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Government Postgraduate Ayurvedic College and HospitalPaprolaDistrictKangraHimachalPradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
perimenopausal women |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa Kalpa, Reference: का. क. शतपुष्पा शतावारीकल्प 10-13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -milk), Additional Information: -it is a classical medicine used as a rasayana.(2) Medicine Name: Shatapushpa Vaginal Gel, Reference: का. क. शतपुष्पा शतावारीकल्प 10-13, Route: Vaginal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(ml), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -it is a classical medicine used as a rasayana. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Kalpa, Reference: का. क. शतपुष्पा शतावारीकल्प 10-13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -milk), Additional Information: -(2) Medicine Name: Shatavari Vaginal Gel, Reference: का. क. शतपुष्पा शतावारीकल्प 10-13, Route: Vaginal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(ml), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Female aged between forty and fifty-five years experiencing perimenopausal symptoms.
Classified as perimenopausal according to the STRAW plus ten criteria.
Early perimenopause defined as menstrual cycle variability of seven days or more.
Late perimenopause defined as amenorrhea for sixty days or more but less than twelve months.
Menopause Rating Scale score of ten or more.
Vaginal Health Index Score of ten or more.
Willing and able to participate for a duration of twelve weeks. |
|
| ExclusionCriteria |
| Details |
Patients with evidence of malignancy.
Patients who have undergone surgical menopause.
Established cases of any mental illness.
Prolonged use of drugs affecting study outcomes for more than six weeks, including corticosteroids, antidepressants, anticholinergics, and hormone replacement therapy.
Patients with major systemic diseases requiring long term treatment.
Patients who are alcohol dependent and or drug dependent.
History of hypersensitivity to any of the trial drugs or their ingredients.
Any other condition which the Principal Investigator considers may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in associated symptoms related to Perimenopause.
|
shatavari kalpa and shatapushpa orally for 84 days daily and shatavari vaginal gel and shatapushpa vaginal gel intravaginally 3 times a week for 84 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of Oxidative stress markers. |
before and after trial oxidative stress level. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/06/2026 |
| 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="0"
Months="9"
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
|
Research report will be soon published after the completion
of trial 40 patients fulfilling the
inclusion and exclusion criterias will be randomly selected
from the OPD and IPD of
department of Prasuti Tantra evum Stri Roga , RGGPG
Ayurvedic College and Hospital
Paprola Distt Kangra HP. Patients will be divided into 2
groups of 20 each.
1. Patient will be managed
with Shatavari Kalpa orally with Shatavari Vaginal Gel intravaginally in 1
group. 2. Patient will be managed with Shatapushpa Kalpa orally with Shatapushpa
Vaginal Gel intravaginally in 2 group.
Total Duration:
The total duration of the study will be 12 weeks (84 days).
Follow-up Schedule:
Participants will be assessed at baseline and followed up at the 4th week, 8th
week, and 12th week.
Visit 1 (Baseline Assessment):
At baseline, a detailed symptom assessment will be carried out using the
Menopause Rating Scale (MRS) and Vaginal Health Index Score (VHIS). Oxidative
stress markers will be evaluated. Participants will also be staged according to
the STRAW +10 criteria.
Visit 2 (4th Week Follow-up):
At the 4th week, participants will undergo a compliance check. Symptom
assessment will be performed, and any adverse effects will be monitored and
recorded.
Visit 3 (8th Week Follow-up):
At the 8th week, compliance with the intervention will again be assessed.
Symptom evaluation will be conducted, and adverse effects will be monitored.
Visit 4 (12th Week – Final Assessment):
At the end of 12 weeks, final symptom assessment will be done using MRS and
VHIS. Oxidative stress markers will be re-evaluated, and final outcome
assessment will be performed to determine the efficacy of the intervention.
Result will be assessed on the basis of subjective and
objective criteria. |