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CTRI Number  CTRI/2017/02/007825 [Registered on: 10/02/2017] Trial Registered Retrospectively
Last Modified On: 20/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [PANCHAKARMA PROCEDURE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment for menstrual period problems by panchakarma therapy and ayurvedic medicine 
Scientific Title of Study   A comparative clinical study on the effect of Vamana karma and Bhadradi kaphanashaka kala basti and Shatapushpadi ghanawati in the management of Aartava kshaya wsr Polycystic ovarian syndrome (PCOS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhingardive Kamini Balasaheb 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda 
Address  Dept of Panchakarma National Institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  07877736643  
Fax    
Email  drkamini111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santoshkumar Bhatted 
Designation  Asso Prof and HOD 
Affiliation  National Institute of Ayurveda 
Address  Dept of Panchakarma National Institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  09414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santoshkumar Bhatted 
Designation  Asso Prof and HOD 
Affiliation  National Institute of Ayurveda 
Address  Dept of Panchakarma National Institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  09414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Hospital and Research centre Jaipur Rajasthan India 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Amer road Jorawar Singh gate Jaipur Rajasthan 
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 Bhingardive Kamini Balasaheb  National Institute of Ayurveda  Hospital and Research centre Dept of Panchakarma OPD no 2 Amer road Jorawar Singh gate Jaipur Rajasthan
Jaipur
RAJASTHAN 		 07877736643

drkamini111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E749||Disorder of carbohydrate metabolism, unspecified. Ayurveda Condition: Aartava kshaya, PCOS DIAGNOSED CASES OF AGE GROUP 20 TO 40 YRS WHICH ARE FIT FOR VAMANA AND BASTIKARMA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bhadradi kaphanashaka kala basti followed by Shamana therapy by Shatapushpadi ghanawati  Bhadradi kaphanashaka kala basti means rectal administration of medicated enema for 16 days followed by Shamana therapy with Shatapushpadi ghanawati 1gm that is 2 pills each of 500mg orally for twice in a day with Lukewarm water for 45 days 
Intervention  Vamana Karma followed by Shaman therapy by Shatapushpadi ghanawati  Vamana Karma means Therapeutic emesis by oral administration of Ikshwaku beeja choorna 5 to 6 gm with other conventional drugs like Yashtimadhu Vacha Rock salt and Honey followed by Shaman therapy with Shatapushpadi ghanawati 1gm that is 2 pills each of 500mg orally for twice in a day with Lukewarm water for 45 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1 Age group 20 to 40 yrs both unmarried and married patients
2 PCOS diagnosed cases by revised rotterdam criteria
3 Irregular menses scanty menses due to anovulatory cycle
4 Patient fit for Vamana and Bastikarma 
 
ExclusionCriteria 
Details  1 Cervical tumor polyp Ca cervix
2 Uterine fibroid
3 Congenital anomalies in female genital tract
4 Tubercular endometritis
5 Congenital adrenal hyperplasia
6 HIV VDRL HbsAg positive
7 Malignant disease and patients on cytotoxic drugs
8 Patient not fit for Vamana and Bastikarma 
 
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 
regulation of normal menstrual pattern and assesment of disease condition including factors like obesity hirsutism etc  60 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
regulation of normal menstrual pattern and assesment of PCOS related complications.  15 DAYS 60 DAYS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/07/2015 
Date of Study Completion (India) 18/07/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 2 publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is a randomised open labelled parallel group comparing effect of Vamana karma (therapeutic emesis)  and Basti karma (medicated enema) followed by Shatapushpadi Ghanawati in both the groups for 45 days in 30 patients (15 patients in each group) of polycystic ovarian syndrome is conducting in National Institute of Ayurveda in India.
Vamana karma is a shodhana therapy  in which Snehapana with Murchita tila taila followed by Vamana procedure by Ikshwaku beeja choorna yoga given as per standard Panchakarma protocol according to patient`s Agni and Koshtha stithi till Samyaka shudhi lakshana will be acheived.
Basti karma with Bhadradi kaphanashaka basti in Kala basti schedule ( 16days) ,initially 2 Aanuvasana basti with Sarshapa oil followed by alternate Aanuvasana(Medicated oil enema) and Niruha(decoction enema) combination followed by Aanuwasana basti (medicated oil enema) at the end.
The primary outcome measures are regulation of normal menstrual pattern and assesment of disease condition including factors like obesity, hirsutism etc after 60 days of treatment. The secondary outcome is regulation of normal menstrual pattern and assesment of PCOS related complications at 15 days and 60 days.
 
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