| CTRI Number |
CTRI/2024/05/067277 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dashamoola ksheera paka and R P vati in Periods pain |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Dashamoola Ksheera Paka and Rajapravartini Vati followed by Matrabasti in Udavartini Yoni Vyapath w.s.r 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 Lakshmi D R |
| Designation |
PhD Scholar |
| Affiliation |
N K Jabshetty Ayurvedic Medical College & P G Center Bidar |
| Address |
Department of Prasuti Tantra and Stree Roga
N K Jabshetty Ayurvedic Medical College & P G Center Bidar and
RGESAMC RON
Bidar
KARNATAKA
585403
India |
| Phone |
8123021272 |
| Fax |
|
| Email |
lakshmidr1509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridevi Swamy |
| Designation |
Professor & HOD |
| Affiliation |
N K Jabshetty Ayurvedic Medical College & P G Center Bidar |
| Address |
Department of Prasuti Tantra and Stree Roga
N K Jabshetty Ayurvedic Medical College & P G Center Bidar
Bidar
KARNATAKA
585403
India |
| Phone |
9945572704 |
| Fax |
|
| Email |
drshrideviswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sridevi Swamy |
| Designation |
Professor & HOD |
| Affiliation |
N K Jabshetty Ayurvedic Medical College & P G Center Bidar |
| Address |
Department of Prasuti Tantra and Stree Roga
N K Jabshetty Ayurvedic Medical College & P G Center Bidar
Bidar
KARNATAKA
585403
India |
| Phone |
9945572704 |
| Fax |
|
| Email |
drshrideviswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| N K Jabshetty Ayurvedic Medical College & P G Center
Bidar Karnataka India
Pin code - 585403 |
|
|
Primary Sponsor
|
| Name |
Dr Lakshmi D R |
| Address |
N K Jabshetty Ayurvedic Medical College & P G Center Bidar Karnataka India
Pin code - 585403
Karnataka
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Lakshmi D R |
Hospital opd of Prasuti Tantra and stree Roga N K Jabshetty Ayurvedic Medical college Bidar |
N K Jabshetty Ayurvedic Medical College & P G Center Bidar karnataka India - 585403
and RGESAMC RON
Bidar
KARNATAKA |
8123021272
lakshmidr1509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NKJ ayurvedic Medical College Bidar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z608||Other problems related to social environment. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamoola Ksheera Paka, Reference: Charaka Samhita Chikitsa Sthana 30th Chapter Sloka number 110-112 , Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Dashamoola Ksheera Paka 50ml BD followed by Matrabasti 60ml for 5 Days before commencement of menstrual cycle for consecutive 3 cycles | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rajapravartini Vati, Reference: Bhaishajya Ratnavali Stree rogadhikara Sloka Number 233 to 235, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Rajapravartini Vati 250mg BD followed by Matrabasti 60ml for 5 days before commencement of menstrual cycle for 3 consecutive cycles |
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.Age Group Menarche to 30 years
2.Patients with "Pratyatma Lakshana" of Udavartini Yoni Vyapath
3.patient who are willing to participate in our treatment
|
|
| ExclusionCriteria |
| Details |
1. Patients with Chronic general illness and Systemic disorders.
2.Patients with intrauterine contraceptive devices, oral contraceptives.
3.Any Congenital anomalies
4.Any uterine pathology - fibroid, Adenomyosis, endometriosis, PID, Menorrhagia etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Dashamoola Ksheera paka followed by Moorchita taila matra basti is not effective
in Udavartini Yoni Vyapath.
2.Dashamoola Ksheera paka followed by Moorchita taila matra basti is effective in Udavartini Yoni Vyapath
3.Rajapravartini Vati followed by Murchita taila matra Basti is not effective in Udavartini Yoni Vyapath
4.Rajapravartini Vati followed by Murchita taila matra Basti is effective in Udavartini Yoni Vyapath. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/05/2024 |
| 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="3"
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
|
A Comparative Clinical Study to Evaluate the Efficacy of Dashamoola ksheera Paka and Rajapravartini Vati followed by Matra Basti in Udavartini Yoni Vyapath W.S.R To Primary Dysmenorrhoea - A Sample size of 100 patients, 2 group with random allocation. Group A : Dashamoola Ksheera Paka 50 ml BD followed by Matrabasti (60ml) for 5 days before commencement of Menstrual Cycle and Group B : Rajapravartini vati 250mg BD followed by Matrabasti (60ml) for 5 days before commencement of Menstrual Cycle and for 3 consecutive cycles. results will assessed statistically. |