| CTRI Number |
CTRI/2025/03/082736 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Herbal Remedies and Tranexamic Acid for Managing Heavy Menstrual Bleeding: A Clinical Study" |
|
Scientific Title of Study
|
Comparative study of Herbal anti- Fibrinolytic with Tranexamic Acid for the Management of Heavy Menstrual Bleeding of Endometrial origin :A Randomized controlled Trial
|
| 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 Anuja Sudhakar Pawar |
| Designation |
PG Scholar |
| Affiliation |
Bharati vidyapeeth University Pune |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9921752077 |
| Fax |
|
| Email |
anuja.pawar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Surendra Mohite |
| Designation |
Professor and HOD, Dept of Prasuti Tantra Evam Stri Roga |
| Affiliation |
Bharati Vidyapeeth University Pune |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822004562 |
| Fax |
|
| Email |
swati.mohite@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Surendra Mohite |
| Designation |
Professor and HOD, Dept of Prasuti Tantra Evam Stri Roga |
| Affiliation |
Bharati Vidyapeeth University Pune |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822004562 |
| Fax |
|
| Email |
swati.mohite@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital Dhankawadi Pune-411043 Maharashtra. |
|
|
Primary Sponsor
|
| Name |
DrAnuja Sudhakar Pawar |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrAnuja Sudhakar Pawar |
Bharati Ayurveda Hopsital pune |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga Opd-no.10), katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA |
9921752077
anuja.pawar-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Ethics Committee[BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: patha, dhamasa, indrayava, dadima pushpa choorna, Reference: Arsha chikitsa adhyaya, charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: 500MG TABLET (OF INDRAYAVA,DHAMASA,PATHA AND DADIMA PUSHPA EACH 2.5GM) TDS FOR 5 DAYS (FOR 3 MONTHS)
TAB PAUSE 500MG TDS FOR 5 DAYS (3 MONTHS ) | | 2 | Comparator Arm (Non Ayurveda) | | - | TRANEXEMIC ACID 500MG | TRANEXEMIC ACID (TAB PAUSE ) 500MG TDS WILL BE GIVEN FOR 5 DAYS (3 MONTHS) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Female Patients under reproductive age between menarche and menopause (18-45yrs)
2) Patients with complaints of excessive, prolonged menstrual bleeding or intermenstrual bleeding.
3) Patient with Hb % more than 9gm.
|
|
| ExclusionCriteria |
| Details |
1) Patients with thyroid dysfunction.
2) Patients having cervical pathologies like fibroid, carcinoma & polyp, fibroid uterus and malignancies.
3) Patients with IUCD.
4) Patients with threatened or spontaneous abortion or pregnancy related bleeding.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the menstrual blood loss.
Reduction in the PBAC score less than 100.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Regular menstrual cycle.
Improvement/ stable in Hb %
No side effect of drugs.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
The study will conducted after obtaining permission from institutional ethical community & will beregistered CTRI India. As per inclusion criteria patient will be selected & screening done at OPD. Subjective & Objective parameters will be checked & noted. Whole research procedure & Aim will be clearly informed to patients hence Form will be signed byenrolled participants & case report form will be filled. |