| CTRI Number |
CTRI/2025/02/079885 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of vachadi churna and Chaturbeeja churna in the management of Primary dysmenorrhoea |
|
Scientific Title of Study
|
A Randomized Comparative Clinical study to Evaluate the efficacy of vachadi churna and Chaturbeeja churna in the management of Udavartini Yonivyapada w.s.r to Primary Dysmenorrhoea |
| 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 Pooja Nivrutti Ugalmugale |
| Designation |
Post Graduate Scholar in Prasuti Tantra Evam Stree Roga |
| Affiliation |
Dr.N.A.Magadum Ayurvedic medical college, Hospital and Research centre Ankali-591213 |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital And Research centre Ankali591213 Taluka Chikodi Dist Belgaum
Department of Prasuti Tantra Evum Stree Roga Dr N.A Magadum Ayurvedic Medical College, Hospital and Research centre Ankali-591213 Taluka-Chikodi Dist-Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
9822270955 |
| Fax |
|
| Email |
ugalmugalepooja228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana S Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
Dr.N.A.Magadum Ayurvedic medical college, Hospital and Research centre Ankali-591213 |
| Address |
Department of Prasuti Tantra Evum Stree Roga Dr.N.A.Magadum Ayurvedic medical college Hospital And Research centre Ankali 591213
Department of Prasuti Tantra Evum Stree Roga Dr.N.A.Magadum Ayurvedic medical college, Hospital and Research centre,Ankali-591213 Taluka-Chikodi Dist-Belgaum
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drsuhasgkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana S Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
Dr.N.A.Magadum Ayurvedic medical college, Hospital and Research centre Ankali-591213 |
| Address |
Department of Prasuti Tantra Evum Stree Roga Dr.N.A.Magadum Ayurvedic medical college Hospital And Research centre Ankali 591213
Belgaum
KARNATAKA
591213
India |
| Phone |
9480017899 |
| Fax |
|
| Email |
drsuhasgkulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital And Research Center Ankali 591213 Taluka-Chikodi,Dist-Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Nivrutti Ugalmugale |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital And Research centre Ankali591213 Taluka-Chikodi Dist-Belgaum |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Nivrutti Ugalmugale |
Dr N A Magadum Ayurvedic Medical College Hospital And Research Center,Ankali.591213 |
Department of Prasuti Tantra evam Stree Roga Dr N A Magadum Ayurvedic Medical College Hospital And Research Center Ankali591213 Taluka Chikodi Dist Belgaum karnataka
Belgaum
KARNATAKA |
9822270955
ugalmugalepooja228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr N A Magadum Ayurvedic Medical College Hospital And Research centre Ankali-591213 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi churna, Reference: Bhaishajya kalpana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: -nill | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeeja Churna , Reference: Bhaishjya Ratnawali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: Nill |
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Patients with Hb of more than 10 g/dl
Patients diagnosed as primary dysmenorrhoea
Having regular menstrual cycles
Patients complaining of painful menstruation for at least two consecutive cycles |
|
| ExclusionCriteria |
| Details |
Patients having congenital anomalies leading to dysmenorrhoea. Patients having any pelvic pathology. Patients with uterine fibroid.
Known Case of PCOD.
Known Case of Congenital Heart Diseases HTN,DM,TB etc
Patients diagnosed as secondary dysmenorrhoea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done before and after treatment as per the parameters
Subjective criteria vedana-Intensity Duration site Nature
Artavpravrutti Nausea vomiting fatigue
Objective criteria FLA Scale Tenderness |
7 days for 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tenderness
Face leg activity scale |
7 days for 3 consecutive cycles |
|
|
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
Modification(s)
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="1"
Days="6" |
|
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
|
The Present Title A Randomised Comparative Clinical study to evaluate the efficacy of vachadi churna and chaturbeeja churna in the management of UDAVARTINI YONIVYAPADA WITH SPECIAL REFERENCE TO PRIMARY DYSMENORRHOEA Duration of treatment 7 Days starting from 21st days of menstrual cycle and this for 3 consecutive cycles Patients will be examined before starting the treatment In bleeding phase of the previous cycle on 5th day of 1st 2nd 3rd cycle after treatment Group A will be administered with vachadi churna 12 gm per day in 2 divided doses with koshnjal Group B will be administered with chaturbeeja churna 12 gm per day in 2 divided doses Assessment will be done with subjective objective criteria |