| CTRI Number |
CTRI/2025/06/089287 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study of Mudgadya Ghrita in management of Abnormal Uterine Bleeding |
|
Scientific Title of Study
|
Randomized clinical trial of Mudgadya Ghrita in the Management of Asrigdara(Abnormal Uterine Bleeding) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mousumi Boro |
| Designation |
Post graduate trainee |
| Affiliation |
Govt Ayurvedic College and Hospital |
| Address |
Govt Ayurvedic College and Hospital
Kamrup
Assam
781014
India
Kamrup
ASSAM
781014
India |
| Phone |
7002135810 |
| Fax |
|
| Email |
mou.boro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaushalya Khakhlary |
| Designation |
Associate Professor Dept. of Prasuti Tantra evum Stree Roga |
| Affiliation |
Govt. Ayurvedic College and Hospital |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Govt. Ayurvedic College and Hospital, jalukbari, guwahati
Kamrup
Assam
781014
India
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushalya Khakhlary |
| Designation |
Associate professor Dept. of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Govt. Ayurvedic College and Hospital |
| Address |
Department of Prasuti Tantra Evum STree Roga, Govt. Ayurvedic College and Hospital, jalikbari, guwahati
Kamrup
Assam
781014
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital Jalukbari Kamrup Assam 781014 |
|
|
Primary Sponsor
|
| Name |
Mousumi Boro |
| Address |
Govt Ayurvedic College and Hospital
Kamrup
Assam
781014
India |
| 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 Kaushalya khakhlary |
Govt Ayurvedic College and Hospital |
Prasuti Tantra and Stree Roga department/ground floor division/room no 10
Kamrup
ASSAM |
8638787369
drkaushalya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Govt Ayurvedic College and Hospital, jalukbari, Ghy-14, Assam |
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 (Non Ayurveda) | | - | Tranexamic acid | Dose- 500 mg
Route- oral
Frequency - TID after food ( during bleeding period)
Duration -3 month | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mudgadya ghrita, Reference: Yoga ratnakar,streeroga adhikar, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Age group from 18 years to 50 years
Having abnormal uterine bleeding considering duration and quantity of bleeding during menstruation |
|
| ExclusionCriteria |
| Details |
Malignant patients
Coagulation disorders
Severe anaemia
Post menopausal bleeding
Patients with major disease like diabetes mellitus, asthma, kidney disease, liver disease
Uterine fibroid |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in symptoms like
1.srava pramana(amount of bleeding)
2. Srava kaal( duration of bleeding)
3. Rituchakra avadhi(length of menstrual cycle)
4. Angamarda(body ache)
5. Vedana(pain during menstruation) |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marked improvement has noticed in amount, duration of bleeding, length of menstrual cycle, body ache, pain during menstruation |
3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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 Applicable |
| 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 is a comparative study to establish the efficacy of mudgadya ghrita in the management of Asrigdara Total number of patients to be studied is 60 where each group contains 30 samples 30 patients will be given mudgadya ghrita and rest 30 patients will be given tranexamic acid for a total of 3 months patients will be followed up after every menstrual cycle for 3 months |