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CTRI Number  CTRI/2017/03/008215 [Registered on: 27/03/2017] Trial Registered Prospectively
Last Modified On: 29/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Dashamoola Ksheerabasti in Udavartini Yoni vyapat (Primary dysmenorrhoea) 
Scientific Title of Study   A Clinical Study to evaluate the effect of Dashamoola Ksheerabasti in Udavartini Yoni vyapat(Primary dysmenorrhoea) 
Trial Acronym   
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  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital 
Address  DR Lakshmi D R Post Graduate Scholar Department Of Prasuti tantra and Stri Roga Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  8123021272  
Fax  08172-256464  
Email  lakshmietagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayathri Bhat N V 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital  
Address  Dr Gayathri Bhat N V Professor Department Of prasuti Tantra and stri roga Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9844437917  
Fax  08172-256464  
Email  gaya3hassan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Bhat N V 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital  
Address  Dr Gayathri Bhat N V Professor Department Of prasuti Tantra and stri roga Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  9844437917  
Fax  08172-256464  
Email  gaya3hassan@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan-573201 Karnataka India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 lakshmi D R  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital.  OPD No. 16 Department of Prasuti and Stri Roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospita, B M Road, Thanniruhalla, Hassan-573201, Karnataka, India.
Hassan
KARNATAKA 		 8123021272
08172-256464
sdmcah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala manjunatheshwara College of Ayurveda and Hospital, B M Road, Thanniruhalla, Hassan - 573201,Karnataka, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Udavartini (Primary Dysmenorrhoea),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dashamoola Ksheera Basti Dashamoola Ksheera Niruha Basti480ml and Mahanarayana Taila Anuvasana Basti 60ml for 8 days, two Consecutive Cycles   Dashamoola Ksheera Basti Dashamoola Ksheera Niruha Basti480ml and Mahanarayana Taila Anuvasana Basti 60ml for 8 days, two Consecutive Cycles 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patients Complaining Of Painful Menstruation at least Two Consecutive cycles
Patients who are ready to sign informed consent form 
 
ExclusionCriteria 
Details  Patients with Chronic general illness and systemic disorders
Patients with intrauterine contraceptive devices,Contraceptive pills
Any congenital anomalies
Any uterine pathology fibroid adenomyosis endometriosis PID Menorrhagia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of effect Basti will be done after the completion of each Yoga Basti Schedule  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/04/2017 
Date of Study Completion (India) 22/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/12/2017 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Dysmenorrhoea is the most common gynaecological problem faced by women during their active reproductive period which causes significant discomfort and anxiety for the women as well as her family.For the diseases of yoni that to udavartini yonivyapat apana vata is considered as the primary cause and it is said that without vitiation of vata manifestation of yoni rogas are not possible. In ayurveda line of treatment is to correct Vata prakopa and Basti is the line of treatment in Vata rogas. Hence is the treatment of udavartini Yoni vyapat Dashamoola is considered as best vatahara , when processed with Ksheera,acts as a brimhana , viloma gati of vata is responsible for udavartini yoni vyapat and Dashamoola does vata anulomana.Primary dysmenorrhoea is the one where thetre is no identifiable pelvic pathology . Aiming this in the present study Yoga basti with Dashamoola ksheera niruha and mahanarayana taila anuvasana basti been selected.
This is an exploratory single arm open label clinical trial at inpatient department level with pre and post test design. The selected patients will be given with Dashamoola ksheera niruha basti and Mahanarayana taial anuvasana basti in Yoga basti schedule for 8 days after completion of menstruation for Two consecutive cycles. Assessment would be done based on reduction in severity,duration of symptoms will be based on scoring system.

 
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