| CTRI Number |
CTRI/2025/03/081720 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Vishwailadi choorna and Indrayavadi yoga in the management of Raktapradara w.s.r to dysfuntional utrine bleeing |
|
Scientific Title of Study
|
A comparative clinical study to evaluate effect of vishwailadi choorna and indrayavadi yoga in the management of Raktapradara wsr to DUB |
| 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 Mahindrakar Ishani Prasad |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and research centre |
| Address |
Dr N A Magadum ayurvedic Hospital, dept of prasuti tantra, OPD no.1, Ankali Tq- Chikodi Dist- Belagavi, Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
9405404371 |
| Fax |
|
| Email |
mahindrakarishani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayali Pashte |
| Designation |
Associate Professor |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and research centre |
| Address |
Dr N A Magadum ayurvedic Hospital, dept of prasuti tantra, OPD no.1, Ankali Tq- Chikodi Dist- Belagavi, Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
7506679499 |
| Fax |
|
| Email |
sayali90p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahindrakar Ishani Prasad |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and research centre |
| Address |
Dr N A Magadum ayurvedic Hospital, dept of prasuti tantra, OPD no.1, Ankali Tq- Chikodi Dist- Belagavi, Karnataka
Belgaum
KARNATAKA
591213
India |
| Phone |
9405404371 |
| Fax |
|
| Email |
mahindrakarishani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical college, Hospital and Research Centre, Ankali 591213
Tq - chikodi dist- Belagavi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Mahindrakar Ishani Prasad |
| Address |
Dr N A Magadum Ayurvedic Medical college, Hospital and Research Centre, Ankali 591213 Tq- chikodi Dist- Belagavi, Karnataka, India |
| 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 |
| Dr Mahindrakar Ishani Prasad |
Dr N A Magadum Ayurvedic Medical college hospital and Research centre |
Dr N A Magadum ayurvedic Hospital, dept of prasuti tantra, OPD no.1, Ankali Tq- Chikodi Dist- Belagavi, Karnataka
Belgaum
KARNATAKA |
9405404371
mahindrakarishani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. NAMAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vishwailadi churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Indrayavadi yoga, Reference: yogaratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Excwssive P/V bleeding more than 80 ml since 3 cycles, prolonged P/V bleeding more than 5 days since 3 cycles, patient with Hb more than 8gms% |
|
| ExclusionCriteria |
| Details |
patient with hb less than 8gms%, history of inter menstrual bleeding, organic abnormality like uterine fibroid, endometrial polyps, Adenomyosis, cervical polyp, systemic diseases like bleeding disorders, severe HTN, thyroid disorders, women using IUCD/OCP, pregnant women, PID, venereal diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| presence of excessive and prolonged bleeding with irregular menstrual cycle |
before treatment and 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms with regular menstrual cycle |
before treatment and 10th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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)
|
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
|
The present study title "A COMPARATIVE CLINICAL STUDY TO EVALUATE EFFECT OF VISHWAILADI CHOORNA AND INDRAYAVADI YOGA IN THE MANAGEMENT OF RAKTAPRADARA W.S.R TO DISFUNCTIONAL UTERINE BLEEDING" will be conducted on 40 subjects with 20 in each group with mentioned objective and subjective parameter. one group will be treated with vishwailadi choorna and another group with indrayavadi yoga orally with sukoshna jala for consecutive 3 menstrual cycles, assesment of patient will be done before the treatment and after treatment (10th day) . |