| CTRI Number |
CTRI/2022/12/048303 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
01/12/2022 |
| 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
|
Eladi kasaya in the management of Asrigdara |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Eladi kasaya versus Tab Tranexamic acid in the management of Asrigdara (Heavy menstrual bleeding). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Trapti Agrawal |
| Designation |
Ph.D. Scholar |
| Affiliation |
Mahatma gandhi ayurved college, hospital and research centre |
| Address |
24, Dept of Prasuti tantra evum Striroga, Mahatma Gandhi Ayurved college, Hospital and Research centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9899137789 |
| Fax |
|
| Email |
tripti.obs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiksha P Rathod |
| Designation |
Associate professor |
| Affiliation |
Mahatma gandhi ayurved college, hospital and research centre |
| Address |
24, Dept of Prasuti tantra evum Striroga, Mahatma Gandhi Ayurved college, Hospital and Research centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975578364 |
| Fax |
|
| Email |
pudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiksha P Rathod |
| Designation |
Associate professor |
| Affiliation |
Mahatma gandhi ayurved college, hospital and research centre |
| Address |
24, Dept of Prasuti tantra evum Striroga, Mahatma Gandhi Ayurved college, Hospital and Research centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975578364 |
| Fax |
|
| Email |
pudgal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda college and hospital, salod, Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi ayurved college, hospital and research centre |
| Address |
Mahatma gandhi ayurved college, hospital and research centre, DMIMS, Salod, Wardha, Maharashtra |
| 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 Trapti Agrawal |
Mahatma gandhi ayurved college and hospital |
OPD no.24, Department of Prasuti tantra evam stri roga
Wardha
MAHARASHTRA |
9899137789
tripti.obs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,DMIMS |
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: Eladi kasaya, Reference: Harita samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu and sharkara), Additional Information: intervention will be given for 7 days during menses for 3 conseceutive menstrual cycle | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet tranexamic acid | it is a standard treatment for HMB. it will be given in doses of 500mg tds for 7 days during menses for 3 conseceutive menstrual cycle. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients who are willing to give written consent for the trial.
2. Patients between the age group of 18 to 45years.
3. Patients with excessive bleeding (>80ml) for at least 2 consecutive cycles.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any diagnosed uterine organic pathology like Uterine Fibroid, Adenomyosis, Chronic tubo ovarian mass. Polycystic ovaries
2. Patients with systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
3. Patients with coagulopathy
4. Liver dysfunction
5. Thyroid dysfunction
6. Patients with malignancy or undiagnosed neoplasm.
7. Patients with history of recent abortion.
8. Patients with active genital tuberculosis.
9. Bleeding from the polyps and erosion.
10. IUCD in utero, pelvic endometriosis.
11. Hb < 8 gm/dl.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
reduction of blood loss calculated by pictorial blood assessment chart
|
0,4weeks, 8weeks, 12weeks, 16weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
safety of given medication through occurance of adverse drug reaction
|
4,8,12 week |
| reduction in pain assessed by visual analog scale |
4weeks, 8weeks, 12 weeks, 16weeks |
| improvement in hemoglobin |
0 and 16 weeks |
| quality of life assessment using menorrhagia impact quessionnaire |
0 and 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
02/01/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This clinical trial has been conducted as a research work under the Ph.D. programme. This is a randomized, single blind, standard controlled, equivalence clinical trial to evaluate the comparative efficacy of Eladi kasaya versus tablet Tranexamic acid in the management of Asrigdara (Heavy menstrual bleeding) |