| CTRI Number |
CTRI/2025/10/095696 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to See the Effect of Gulmahar Kashaya and Vaitarana Basti in Women with Endometriosis |
|
Scientific Title of Study
|
Efficacy of Gulmahar Kashaya and Vaitarana Basti in the management of Endometriosis - An Exploratory Clinical Study |
| 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 Sadia Kausar |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
405, seminar hall, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9625673062 |
| Fax |
|
| Email |
kausarsadia99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
405, seminar hall, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
7905824977 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
405, seminar hall, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
7905824977 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| 405, seminar hall, All India Institute of Ayurveda, Gautam Puri, Mathura Road, Sarita Vihar, New Delhi - 110076 |
|
|
Primary Sponsor
|
| Name |
Department of Prasuti Tantra evum Stree Roga |
| Address |
405 seminar hall, all india institute of ayurveda, sarita vihar, delhi - 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sadia Kausar |
Department of Prasuti Tantra evum Stree Roga |
all india institute of ayurveda, sarita vihar, delhi - 110076
South
DELHI |
96256 73062
kausarsadia99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N809||Endometriosis, unspecified. Ayurveda Condition: GULMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gulmahar Kashaya, Reference: सहस्रयोगम (कषाय प्रकरण ), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: - water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बस्तिः | (Procedure Reference: चक्रदत्त (निरुहाधिकार/33-34), Procedure details: As form of niruha basti in Yoga basti (3 days in 8 days of procedure). 392 ml before meal.)
| | 3 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: भैषज्य रत्नावली (आमवात चिकित्सा/64-67), Procedure details: As form of anuvasan basti in Yoga basti (5 days among 8 days procedure). 98 ml after meal.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. USG confirmed cases of endometriotic cyst less than 5 cm.
2. CA-125 less than 200 U per ml
3. Female patients between the age of 20-40 years diagnosed with endometriosis, willing to participate.
4. Patients presenting with any of the complaint of pelvic pain, dysmenorrhea, dysuria, dyspareunia, dyschezia and irregular menstrual cycles along with endometriotic cyst in USG.
5. Those patients who are eligible for Basti karma.
|
|
| ExclusionCriteria |
| Details |
1. Patients with malignancy of genital tract.
2. Patients of chronic diseases like uncontrolled hypertension and diabetes mellitus.
3. Pregnant or lactating women.
4. Patients on hormonal therapy.
5. Those patients who are not eligible for Basti karma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in endometriotic cyst size in USG (pelvis) findings. |
Baseline and one month after completion of three cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in severity of pain, symptoms of dysmenorrhea, dyspareunia, dysuria, and dyschezia, enhancement of menstrual regularity, and an overall improvement in Quality of Life. |
Baseline, after each cycle of procedure and one month after completion of three cycles |
|
|
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)
|
01/01/2026 |
| 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
|
This clinical trial is being conducted to evaluate the effect of Gulmahar Kashaya and Vaitarana Basti in the management of endometriosis. Endometriosis is a condition where tissue similar to the uterine lining grows outside the uterus, often causing pain and infertility. The study will include female patients between 20–40 years of age with ultrasonography-confirmed endometriotic cysts less than 5 cm in size. The intervention involves administration of Gulmahar Kashaya orally and Vaitarana Basti as part of Yoga Basti procedure. The main outcome of the study will be reduction in cyst size as seen on ultrasonography. Secondary outcomes will include improvement in pain and quality of life. This study will help to explore safe and effective Ayurvedic management options for endometriosis. |