FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036512 [Registered on: 15/09/2021] Trial Registered Prospectively
Last Modified On: 14/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of Patha (Cissampelos pariera) in patients with painful menstruation. 
Scientific Title of Study   A Clinical Study to Evaluate the effect of Patha (Cissampelos pareira linn.) on Kashtartava W.S.R to Dysmenorrheoa  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himani 
Designation  Pg student 
Affiliation  Government Ayurvedic College Patiala 
Address  Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India 
Phone  7413055970  
Fax    
Email  himania007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bal Krishan Sharma Kaushik 
Designation  Vice Chancellor 
Affiliation  Government Ayurvedic College Patiala 
Address  Guru Ravidas Ayurved University,Punjab, Hoshiarpur
Guru Ravidas Ayurved University,Punjab, Hoshiarpur
Hoshiarpur
PUNJAB
146001
India 
Phone  9463369477  
Fax    
Email  acharyakaushik54@gmail.com  
 
Details of Contact Person
Public Query  
Name  Himani 
Designation  pg student 
Affiliation  Government Ayurvedic College Patiala 
Address  Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Post Graduate Training and Research Institute Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India 
Phone  7413055970  
Fax    
Email  himania007@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Training and Research Institute, Government Ayurvedic College and Hospital, Patiala 
 
Primary Sponsor  
Name  Himani 
Address  Post Graduate Training and Research Institute Government Ayurvedic College Patiala 
Type of Sponsor  Other [Post Graduation scholar] 
 
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 
Himani  Government Ayurvedic Hospital, Patiala  Gynaecology department, second division, room number 12
Patiala
PUNJAB 		 7413055970

himania007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: kashtartava,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patha, Reference: Sushruta samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: 25 gm of authenticated dried roots of patha will be boiled with 400ml of water and will be reduced to 1/4th i.e. 100ml of decoction will be prepared per day per patient.
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patients or parents of the young patients who agree to give written consent
patients having chief complaint of painful menses
patient suffering from primary dysmenorrhoea for more than 3 cycles 
 
ExclusionCriteria 
Details  Patients or parents of the young patients who do not agree to give written consent.
Patient with chronic systemic illness and uterine pathology like fibroid, adenomyosis, endometriosis.
Patient with intrauterine contraceptive devices.
Patient suffering from hypothyroidism or Hyperthyroidism. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Menstruation is not painful anymore or is reduced to a substantial amount.   3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Menstruation is still painful to the same extent as before Intervention.  3 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/09/2021 
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="1"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   the research will be published in form of pg thesis 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [himania007@gmail.com].

  6. For how long will this data be available start date provided 01-09-2021 and end date provided 01-09-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   this study is randomized open interventional study, to  measure the efficacy of decoction of patha given at  a dose of 50 ml twice a daily for three menstrual cycles that will be conducted in a single centre in india. The primary outcome measures will be the pacification or complete resolution of primary dysmenorrhea by decoction of patha. The secondary outcome will be no efficacy of decoction of patha in managing the pain of primary dysmenorrhea. 
Close