| CTRI Number |
CTRI/2025/09/095016 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| 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 Medicine and Conventional Medicine for the Treatment of Heavy Menstrual Bleeding in Women |
|
Scientific Title of Study
|
Comparative Efficacy of Darvyadi Kwatha verses Tranexamic acid 500mg in the management of Raktapradara (Menorrhagia): 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 Shruti Prakash Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room no 9 Strirog OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8624812326 |
| Fax |
|
| Email |
shrutibhandari987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyashri Chaudhari |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) WardhaA |
| Address |
Room no 9 Strirog OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096415920 |
| Fax |
|
| Email |
dr.bhagyashrichaudhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Prakash Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room no 9 Strirog OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8624812326 |
| Fax |
|
| Email |
shrutibhandari987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H), Wardha Dist-
Wardha Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College, Hospital and Research Centre |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Centre
Salod(H) Wardha. MAHARASHTRA 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shruti Prakash Bhandari |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
Room No 09,
Strirog OPD,
Mahatma Gandhi
Ayurved College,
Hospital and Research
Centre Salod(H)
Wardha.
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8624812326
shrutibhandari987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Institutional Committee, Salod(H) Wardha, Maharashtra 442001 |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Kwatha, Reference: Bhavprakasha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Tranexamic acid | 500 mg for 7 Days Orally. |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Written informed consent from patients willing to participate in the study
Females aged 19 to 40 years presenting with classical symptoms of Raktapradar Menorrhagia
Women with a baseline PBAC score indicating mild to moderate menorrhagia PBAC score between 100 and 300 will be included in the study
Complaints of excessive more than 80ml and or prolonged more than or equal to 8days menstrual bleeding
Regular menstrual history for the past three cycles prior to enrollment
|
|
| ExclusionCriteria |
| Details |
Patients with known systemic illnesses such as tuberculosis or immunocompromised status
Structural or malignant reproductive tract disorders based on clinical evaluation
Current use of hormonal therapy oral contraceptive pills or intrauterine contraceptive devices IUCD
Patients with bleeding disorders or those on anticoagulant therapy
History of ongoing pelvic inflammatory disease
Patient unwilling or unable to comply with study requirements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exploring the efficacy of interventions in managing the full spectrum of Raktapradar Menorrhagia including moderate bleeding regular cycles pelvic discomfort weakness and systemic symptoms with assessment via PBAC score and clinical response |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/12/2025 |
| 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="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
|
This clinical trial compares the effectiveness of Darvyadi Kwatha a traditional Ayurvedic herbal decoction with Tranexamic Acid 500 mg a modern antifibrinolytic drug in managing heavy menstrual bleeding Raktapradara Menorrhagia The study evaluates symptom relief blood loss reduction and overall well being to determine whether Darvyadi Kwatha can serve as a safe and effective alternative therapy |