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CTRI Number  CTRI/2022/08/044876 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 22/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   To evaluate the effect of virechana (purgation) and varunadi ghan vati on Poly cystic ovarian syndrome.  
Scientific Title of Study   A clinical study to evaluate the combined effect of virechana followed by varunadi ghan vati(kalpita yoga) on 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 Divya Rajpurohit 
Designation  P.G.Scholar 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research, Jodhpur  
Address  PG Dept.Of Prasuti Tantra Evum Stri Roga,University Post Graduate Institute of Ayurved Studies and Research ,Dr Sarvepalli Radhakrishnnan Rajasthan Ayurved University Jodhpur,Rajasthan 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  6376539436  
Fax    
Email  divyabarwa1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Neelima  
Designation  Professor , Head of Department  
Affiliation  University Post Graduate Institute of Ayurved Studies and Research, Jodhpur  
Address  PG Dept.Of Prasuti Tantra Evam Stree Roga,University Post Graduate Institute of Ayurved Studies and Research ,Dr Sarvepalli Radhakrishnnan Rajasthan Ayurved University Jodhpur,Rajasthan 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9610350131  
Fax    
Email  aspneelima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya rajpurohit  
Designation  P.G. Scholar  
Affiliation  University Post Graduate Institute of Ayurved Studies and Research, Jodhpur  
Address  PG Dept.Of Prasuti Tantra Evam Stree Roga,University Post Graduate Institute of Ayurved Studies and Research ,Dr Sarvepalli Radhakrishnnan Rajasthan Ayurved University Jodhpur,Rajasthan 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  6376539436  
Fax    
Email  divyabarwa1997@gmail.com  
 
Source of Monetary or Material Support  
University Post Graduate Institute of Ayurved Studies and Research ,jodhpur,rajasthan 
 
Primary Sponsor  
Name  University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan  
Address  University Post Graduate Institute of Ayurved Studies and Research, Dr. sarvepalli Radhakrishnan Ayurved University , jodhpur , Rajasthan , 342037 ,India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Divya rajpurohit  PG Dept.Of Prasuti Tantra Evam Stree Roga,University Post Graduate Institute of Ayurved Studies and Research ,Dr Sarvepalli Radhakrishnnan Rajasthan Ayurved University Jodhpur,Rajasthan 342037 , India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya rajpurohit  University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan  PG Dept.Of Prasuti Tantra Evam Stree Roga,University Post Graduate Institute of Ayurved Studies and Research ,Dr Sarvepalli Radhakrishnnan Rajasthan Ayurved University Jodhpur,Rajasthan 342037 India
Jodhpur
RAJASTHAN 		 6376539436

divyabarwa1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe University Post Graduate Institute of Ayurved Studies and Research Jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Varunadi Ghan Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information:
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak siddhi sthan 2/13, Procedure details: Patient is subjected to snehapana(3-7days)first then sarwang snehan and swedan for 3 days .after this Virechana drug is Administered drug quantity is determined acc to nature of individuals kostha.after a short while of administering the drug purgation starts after this procedure samsarjana karma will be advised for 1.5-5 days.)
(1) Medicine Name: Trivrita modak , Reference: Charak kalpa sthan 7/38, Route: Oral, Dosage Form: Modaka, Dose: 48(g), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patients diagnosed cases of PCOS by the Rotterdam criteria
2.Age: Patients aged between 16-40 years.
3.The patients who are fit for the virechana procedure were only considered for The study.
4.Patients willing for Informed consent.
 
 
ExclusionCriteria 
Details  1.Known congenital adrenal hyperplasia, androgen secreting tumors were excluded which also present the complaints of oligomenorrhea or irregular cycles and anovulation.
2.Other endocrinal disorders like Cushing’s syndrome were excluded as they also precipitate the pathology of PCOS.
3.The patients with BMI > 30 are considered to be morbidly obese and are not fit for the panchakarma procedures. Hence they were not considered for the study.
4.The patients suffering with rectal pathologies like fissure, fistulas were excluded.
5.The patients who were unfit for virechana procedure were excluded.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in ovarian size ,volume ,stromal pattern , and in menstrual irregularities.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in FBS , lipid profile , BMI ,WHR Ratio ,and on acne , Hirsutism.   60 days  
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/09/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Polycystic Ovarian Syndrome is the most common disease in the female population among adolescence and reproductive age group mainly due to the adoption of westernized culture. and due to change in the lifestyle and increasing Stress.  Prevalence of PCOS has reported incidence rate of 2.2% to 26% worldwide & in india ranges from 3.7-22.5% depending on the criteria used for diagnosis. PCOS is a heterogeneous Disorder presenting with irregular menstruation, infertility due to anovulation, polycystic Ovaries, hyperandrogenism (hirsutism,acne), insulin resistance, obesity, type 2 diabetes and raised cholesterol levels Besides Infertility, other symptoms associated with PCOS (like hirsutism, obesity, acne and weight Gain) can affect self-esteem of the women. It thus affects the women on all levels- physical,Mental and psychological levels. 

To assess the efficacy of â€œVIRECHANA” with â€œTRIVRIT MODAK” &“VARUNADI GHAN VATI” in the management of PCOS.

Virechana does shodhana by removal of aavarana , vata anulomana and catering the normal functioning of dosha. & virechana also increases the bio availability of drugs by opening channels & improve the assimilation of trial drug.Varunadi ghan vati is adopted as shaman chikitsa on the basis of its actions opposite to this disease. content of varunadi ghan vati  is varuna , shigru, . These drug having properties like pittavardhaka, vatakaphahara ,Bhedana,granthiharaguna which are also present in drugs used in previous researches  which are useful in decreasing the size of cyst & formation of artava and helpful for correcting the menstrual irregularties & pcos ovary. 

 
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