| CTRI Number |
CTRI/2025/07/090611 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of Chandanadi vati and Bala tail matra basti to manage excessive bleeding per vaginum |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate the Efficacy of Chandanadi vati And Bala Tail Matra Basti in the Management of Asrigdara W.S.R To Menorrahgia |
| 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 Sima Bharti |
| Designation |
MS Scholar (Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9336525405 |
| Fax |
0 |
| Email |
dr.simamit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shashi Sharma |
| Designation |
Professor & HOD |
| Affiliation |
State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8795545443 |
| Fax |
0 |
| Email |
shashi.chd98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sima Bharti |
| Designation |
MS Scholar(Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow Uttar Pradesh India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
09336525405 |
| Fax |
0 |
| Email |
dr.simamit@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College And Hospital Tulsidas Marg Turiyaganj Lucknow, Uttar Pradesh India 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College And Hospital Tulsidas Marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga
State Ayurvedic College And Hospital Tulsidas Marg Turiyaganj Lucknow, Uttar Pradesh India 226004 |
| Type of Sponsor |
Government 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 Sima Bharti |
State Ayurvedic College and hospital Lucknow Uttar Pradesh India 226004 |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow Uttar Pradesh India 226004
Lucknow
UTTAR PRADESH |
09336525405
0
dr.simamit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Commitee State Ayurvedic College and Hospital Lucknow |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandanadi Vati, Reference: Bhaisajya Ratnavali 66/20-24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Tandulodak ), Additional Information: Bhaisajya ratnavali 66/20-24 is reference of chandanadi churna but here it will be used in the form of Vati with same content
Dose 2 tab BD(500mg each) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bala Taila Matra basti , Reference: Bhel Chikitsa 24/14-18, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Per rectal for 7 days after clearance of menses |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient having excessive, prolonged and intermenstrul bleeding.
2.Patient with age group of 20-45 years.
3.Patient Hb % more than 10 gm |
|
| ExclusionCriteria |
| Details |
1.Patient having uterine fibroid, uterine polyps, adenomyosis.
2.Malignant growth in uterus.
3.Patients considered having thyroid dysfunction, liver dysfunction, coagulation disorders etc.
4.Patient having systemic illness like diabetes, and hypertension etc.
5.Patient with IUCD and OCP.
6.Patient giving history of recent delivery or abortion. |
|
|
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 |
1.To evaluate the efficacy of Chandanadi Vati with Bala Tail matra basti in the management of Asrigdara w.s.r. To Menorrahgia.
2.To Compare the clinical efficacy of Chandanadi vati and Bala tail Matra basti in the management of Asrigdara w.s.r To Menorrhagia. |
1.at 4 weeks
2.at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the critical review of ayurvedic & modern literature on Asrigdara w.s.r. To Menorrhagia.
2.To study the adverse effects of both the trial drug and procedure.
3. To find out safe, effective therapy that covers various clinical conditions of
Asrigdara.
4.Reduction in pain,Duration,and amount of menstrual bleeding. |
after 30days
after 30days
after 30days of trial |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="6"
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 is a randomised, comperative clinical study phase 2 parallel group trial.Comparing the efficacy of chandanadi vati and bala tail matra basti for 3 months in 40 patients.the patient fulfilling clinical criteria for diagnosis of asrigdara(menorrhagia) will be randomly selected from OPD/IPD of Department of Prasuti tantra evum stri roga State Ayurvedic College and Hospital Lucknow and reffered cases from other hospital.A carefully histoy physical examination and nessesary investigation will be performed. futher patient devided into 2 groups. Group A - 20 Patients will be given the trial drug chandanadi vati 2BD (500mg each) will be given orally after meal with Tandulodak from 5th day of menstrual cycle to 1st day of next menstrual cycle with Bala taila (30 -60 ml) matra basti anter clearance of menses fon 3 consecutive cycle. Group B - 20 patients of this group will be given the trial drug Bala tail matra basti after clearance of menses for 3 consecutive cycles. Follow up - On the clearance of each mentrual cycle. |