| CTRI Number |
CTRI/2024/01/061877 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of Atibala Vati with Tab Regestrone in management of heavy menstrual bleeding. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the effect of Atibala Vati in comparison with Tab Regestrone in management of Asrigdara. |
| 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 Mansi Sarvade |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9820384349 |
| Fax |
|
| Email |
mansisarvade36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay G Gavane |
| Designation |
HOD , Streeroga and Prasuti Tantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822254700 |
| Fax |
|
| Email |
dr.sanjaygavane@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSanjay G Gavane |
| Designation |
HOD , Streeroga and Prasuti Tantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822254700 |
| Fax |
|
| Email |
dr.sanjaygavane@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya and seth tarachand ramnath charitable ayurved hospital Rasta Peth pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Ayurvedic Hospital Rasta Peth |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune 11 |
| 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 Mansi Sarvade |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital pune |
OPD no 11 Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA |
09820384349
mansisarvade36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institional Ethics Committee Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta Peth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Regestrone | Regestrone is Synthetic Progestrone |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Increased number of bleeding days that is more than 7 days
2. Quantitative increase in Menstrual blood that is more than 80 ml or more than 3 pads per day.
3. Decreased Intermenstrual period that is less than 21 days |
|
| ExclusionCriteria |
| Details |
1. Traumatic bleeding 2. Post menopausal bleeding
3. Cervical uterine ovarian Neoplasm 4. Fibroid 5. Endometriosis. 6.Bleeding through Gravid uterus
7. cerical polyp and erosion 8. Coagulopathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient was diagnosed on the basis of signs and symptoms described in Ayurvedic texts and Modern approach that is subjective and objective criteria
Subjective Criteria
1. Duration of bleeding in days
2. Quantity of blood loss |
3 6 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
objective criteria
1. USG ET before and after
2.Haemogram count before and after |
15 30 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2024 |
| 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
|
The word Asrugdara got its defination as dirana ( excessive secretion and excretion ) asrig (Menstrual blood) Asrugdara is a condition of excessive or prolonged uterine bleeding which is accompanied wiyh or without menstruation. Atibala has madhur snighda sheeta virya and also one of the content of balya gana Thus it will not only act on doshas but will also help in subsiding the upadrava and symptoms of Raktapradar. |