| CTRI Number |
CTRI/2025/03/082368 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomised controlled trial to study the effect of pradarari churna and pushyanuga churna in the management of asrugdara |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Evaluate The Efficacy Of Pradarari Churna And Pushyanuga Churna In The Management Of Asrigdara(Dysfunctional 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 |
Dr PANKAJA |
| Designation |
PG scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college and hospital Gavimath campus Koppal |
| Address |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college and hospital Gavimath campus Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
08310922653 |
| Fax |
|
| Email |
pankajagaidhankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya M |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college and hospital |
| Address |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college and hospital Gavimath campus Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9480010072 |
| Fax |
|
| Email |
drsupriyaprashanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya M |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddheshwar Ayurvedic Medical College and hospital |
| Address |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college and hospital Gavimath campus Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9480010072 |
| Fax |
|
| Email |
drsupriyaprashanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddheshwar ayurvedic medical college post graduate studies and research centre Gavimath campus Koppal Karnataka 583231 |
|
|
Primary Sponsor
|
| Name |
Dr Pankaja |
| Address |
Shree Jagadguru Gavisiddheshwar Ayurvedic Medical College, post graduate studies and Research centre Gavimath campus, Koppal 583231 |
| Type of Sponsor |
Other [Self(PG Scholar)] |
|
|
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 PANKAJA |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college post graduate studies and research centre |
Shree Jagadguru Gavisiddheshwar ayurvedic medical college post graduate studies and research centre Gavimath campus, Koppal.
Koppal
KARNATAKA |
08310922653
pankajagaidhankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddheshwar Ayurvedic Medical College, post graduate studies and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pradarari Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Sitajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pushyanuga churna, Reference: Charak Chikitsa 30/90-96, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
patient heaving heavy menstrual bleeding with change of 7-8 fully soaked pads/day
prolonged bleeding for more than 7 days
Intermenstrual bleeding within 21 days
Hemoglobin more than 8gm/dl
Both married and unmarried women
|
|
| ExclusionCriteria |
| Details |
Patient diagnosed with genetic bleeding disorder and other systemic coagulative disorders
Medical conditions as Acute PID, Liver disease, Chronic renal disease, HIV, TB, Diabetes mellitus, hypertension and Thyroid disorder
Fibroid uterus,
Uterine polyps, Adenomyosis, Tumors
Pelvic endometriosis
Medication as OCP, Warfarin, Enoxaparin, Apixaban and other anticoagulant drugs
Patient with IUCD, Chronic illness and Postmenopausal bleeding |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Pradarari churna and Pushyanuga churna in Asrugdara |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Pradarari churna and Pushyanuga churna in the management of Arugdara(Dysfunctional uterine bleeding) |
4 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
22/03/2025 |
| 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 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 study is a randomized, parallel group trail comparing the efficacy of Pradarari churna(500mg BID) and Pushyanuga churna(3gm BID) from 3rd day of mensus to throughout the cycle for 2 months in total 40 patients with Asrugdara (Dysfunctional uterine bleeding) that will be conducted in India. The primary outcome measures will be to evaluate the effect of Pradarari churna and Pushyanuga churna. The secondary outcome measures will be to compare the efficacy of Pradarari churna and Pushyanuga churna in the management of Asrugdara. |