| CTRI Number |
CTRI/2021/04/032992 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effectiveness of ayurvedic management for heavy menstrual bleeding. |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the effectiveness of Kutajashtak kwatha and Tranexamic acid in Raktapradar (Menorrhagia) with special reference to cyclic heavy menstrual bleeding- an open randomised control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Subhash Padekar |
| Designation |
PG student |
| Affiliation |
Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210 |
| Address |
Prasuti Tantra Stri Roga department.Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8669047202 |
| Fax |
27749895 |
| Email |
dr.supriyapadekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Subhash Padekar |
| Designation |
PG student |
| Affiliation |
Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210 |
| Address |
Prasuti tantra Stri Roga department.Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8669047202 |
| Fax |
27749895 |
| Email |
dr.supriyapadekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayura M Devadiga |
| Designation |
Assistant Professor |
| Affiliation |
Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar |
| Address |
Prasuti Tantra Stri roga department.Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108103035 |
| Fax |
27749895 |
| Email |
mayura.kundapura@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G. D. Pol foundation Y.M.T. Ayurved medical college and hospital Kharghar Navi Mumbai 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Subhash Padekar |
| Address |
Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210 |
| 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 |
| Dr Supriya Subhash Padekar |
Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar |
Prasuti tantra Stri roga department.Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
8669047202
27749895
dr.supriyapadekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MUHS university |
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
|
| Type |
Name |
Details |
| Intervention |
Kutajashtak kwatha |
Kutajashtak kwatha (48ml) with madhu anupan twice a day before food (apaan kaal) from 3rd day of menses for 5 days for 3 consecutive menstrual cycles. |
| Comparator Agent |
Tranexamic acid |
Tab. TRANEXAMIC ACID 500 mg orally twice a day after food from 3rd day of menses for 5 days for 3 consecutive menstrual cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Age group of patients between 18 to 45 years female.
2. Patient with cyclical excessive Per vaginal bleeding in the form of duration more than 7 days or quantity more than 80ml or both with or without clots during menstrual cycle.
3. Haemoglobin 10 gm% or more.
4. Patient with PID.
5. Patient with uterine fibroid of size less than 12 weeks of pregnancy and patient willing to avoid surgery.
6. Patient with adenomyosis & pelvic endometriosis. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from moderate/severe anaemia (Haemoglobin less than 10 gm%)
2. Suspected cases of spontaneous, threatened or incomplete abortion.
3. Patients with systemic disorders like Thyroid dysfunction, Hypertension, Tuberculosis, Diabetes mellitus.
4. Patient using OC pills.
5. Patient with IUCD (Intra Uterine Contraceptive Device).
6. Genital Malignancy. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stoppage of heavy menstrual bleeding. |
Baseline 3 visits.
Each visit with Follow up on 5th,7th,9th day of menses for 3 consecutive menstrual cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Kutajashtak Kwatha and Tranexamic acid on associated symptoms like pain in lower abdomen, passage of clots, odour and staining of menstrual blood, fatigue. |
Follow up on 5th,7th,9th day of menses for 3 consecutive menstrual cycles. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
22/04/2021 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.supriyapadekar@gmail.com].
- For how long will this data be available start date provided 01-07-2023 and end date provided 31-01-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The present study is the comparative clinical study for completion under MUHS Nashik university.
Total duration of trial is 1 year 6 months 15 days.
Title: A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF KUTAJASHTAK KWATHA AND TRANEXAMIC ACID IN RAKTAPRADAR (MENORRHAGIA) WITH SPECIAL REFERENCE TO CYCLIC HEAVY MENSTRUAL BLEEDING- AN OPEN RANDOMISED CONTROL TRIAL.
study group- 31 patients with Kutajashtak kwatha (48ml) with Madhu anupan twice a day before food (apaan kaal) from 3rd day of menses for 5 days for 3 consecutive menstrual cycles.
Comparative group- 31 patients with Tab. Tranexamic acid 500 mg orally twice a day after food from 3rd day of menses for 5 days for 3 consecutive menstrual cycles.
Study centre- Dr. G. D. Pol foundation Y. M. T. Ayurved Medical college and Hospital Kharghar
PG scholar- Dr. Supriya Subhash Padekar
Guide- Dr. Mayura M. Devadiga |