| CTRI Number |
CTRI/2025/07/091249 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study Comparing a Traditional Herbal Remedy (Vishwa-Eladi Yog) with Norethisterone for Managing Heavy Menstrual Bleeding (Asrigdara) |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF VISHWA-ELADI YOG IN COMPARISON WITH NORETHISTERONE IN MANAGEMENT OF ASRIGDARA |
| 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 Kajal Dnyanadev Saste |
| Designation |
PG Scholar |
| Affiliation |
Tilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Department of stree and prastuti tantra
Tilak ayurvedic mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7038927763 |
| Fax |
|
| Email |
kajalsaste07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRahul Garudkar |
| Designation |
Associate professor |
| Affiliation |
Tilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Department of stree and prastuti tantra
Tilak ayurvedic mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9822777367 |
| Fax |
|
| Email |
drrahulgarudkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Dnyanadev Saste |
| Designation |
PG SCHOLAR |
| Affiliation |
ilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Department of stree and prastuti tantra
Tilak ayurvedic mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7038927763 |
| Fax |
|
| Email |
kajalsaste07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Hospital, Pune-11 |
|
|
Primary Sponsor
|
| Name |
Tilak ayurvedic mahavidyalaya rasta peth Pune |
| Address |
Department of stree and prastuti tantra
Tilak ayurvedic mahavidyalaya rasta peth Pune Maharashtra 411011 |
| 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 |
| DrKajal Dnyanadav Saste |
Seth Tarachand Ramanath Charitable Ayurvedic Hospital Pune |
580/2 Rasta peth Pune Maharashtra 411011
Department - Streerog and Prasutitantra department
Division - 2nd floor
Room no - 2
Pune
MAHARASHTRA |
7038927763
kajalsaste07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Tilak Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishwa-eladi Yog , Reference: Gadnigrah , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Tandulodak ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Norethisterone | 10mg tablet, sabhakta,BID, |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age Group: Women between 25–40 years.
2. Menstrual Duration: Bleeding for more than 7 days per cycle.
3. Blood Loss Volume: More than 80 mL or more than 3 pads per day.
4. Cycle Frequency: Polymenorrhea – Intermenstrual period less than 21 days.
5. Diagnosed conditions including:
Fibroid
Endometriosis
Adenomyosis |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the amount of menstrual blood loss. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in associated symptoms (such as pain, fatigue, or weakness).
2. Changes in hemoglobin levels (to assess improvement in anemia due to bleeding).
3. Changes in menstrual cycle regularity.
4. Improvement in quality of life scores (using a standardized questionnaire).
5. Adverse effects or side effects of both interventions.
6. Patient satisfaction and compliance.
7. Effect on hormonal profile (if applicable, such as estrogen/progesterone levels).
8. Duration of therapeutic effect after discontinuation of treatment. |
3 month |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
The study will be intervened by the treatment of VISHWA-ELADI YOG with Tandulodak and NORETHISTERONE to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |