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CTRI Number  CTRI/2023/07/055891 [Registered on: 31/07/2023] Trial Registered Prospectively
Last Modified On: 28/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of PCOS through Ayurveda and Yoga. 
Scientific Title of Study   A comparative study on the efficacy of Kanchanar Guggulu and Kanchanar Guggulu with yoga module in the management of Polycystic Ovarian Syndrome. 
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 Seema Rani 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic college and Hospital Kurukshetrallege 
Address  Room No. 63 Department of Swasthavritta and Yoga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9466786108  
Fax    
Email  seemaranimd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seema Rani 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic college and Hospital Kurukshetrallege 
Address  Room No. 63 Department of Swasthavritta and Yoga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9466786108  
Fax    
Email  seemaranimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seema Rani 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic college and Hospital Kurukshetrallege 
Address  Room No. 63 Department of Swasthavritta and Yoga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9466786108  
Fax    
Email  seemaranimd@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Government Ayurvedic College and Hospital, kurukshetra 
 
Primary Sponsor  
Name  Dr Jyoti  
Address  OPD no. 2 Department of Swasthavrittha and Yoga. Shri Krishna Government Ayurvedic College and Hospital 
Type of Sponsor  Other [SELF] 
 
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 Jyoti  Shri Krishna Government Ayurvedic College and Hospital  OPD no. 2 Department of Swasthavrittha and Yoga Shri Krishna Government Ayurvedic college and Hospital Kurukshertra
Kurukshetra
HARYANA 		 08307111635

jyotikakran2197@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Tab Kanchanar Guggulu, Reference: Sharngadhra samhita, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -
2Intervention ArmProcedure-Yoga (Procedure Reference: The Positive effects of Asanas and Pranayama on PCOS and How to deal with hormonal imbalance? BijendarSingh1, Jyoti Badola2 , Vijay Laxmi3, Procedure details: The patients in the study group will be trained in the proper practice of Chakkichalan asana, Bhujang Asana, Badhkon asana, Kapalbhati Pranayama will be made to practice for a period of 90 days along with Kanchanar Gugglu. Yoga module will be performed for 60 minutes once in a day (Preferably morning). GMP certified Kanchanar guggulu tablet will be given to the participant of the study.)
(1) Medicine Name: Kanchanar guggulu, Reference: sharngdhara samhita, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: tds, Duration: 90 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Female patient of age group between 18-45 years (both married and unmarried).
2.No history of Yoga Asana exercise.
3.Polycystic ovaries (confirmed by USG  
 
ExclusionCriteria 
Details  Patient who is not willing to give voluntary informed consent.
• Women of age < 18 years and > 45 years.
• Patient will be excluded if the patient skips the Yoga module for more than a week
continuously.
• Patient not willing to participate in life style modification
• Patient with history of chronic systemic illness (cardiac failure, cirrhosis of liver,
hypertension, diabetes mellitus, tuberculosis, chronic renal disease).
• Patient with history of reproductive system abnormalities (excluded clinically and
radiologically, hydrosalpinx, endometriosis, adenomyosis, carcinoma of reproductive organ) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in features of oligomenorrhea.
 		 Duration of treatment - It will be given for 90 days.
Follow up - it will be done on every 15th day during the treatment time period 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Polycystic ovary syndrome features (weight, BMI  90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/08/2023 
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 Applicable 
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   Polycystic ovary syndrome is one of the most common hormonal disorders among women of reproductive age. Polycystic ovary syndrome is a syndrome disease defined by a group of signs (physical findings) and symptoms (patient complaints). Some of the symptoms of Polycystic ovary syndrome include: • Infertility • Irregular menstrual periods • Hirsutism -increased hair growth on the face, chest, back, thumbs, or toes • Acne, oily skin, or dandruff • Weight gain or obesity, usually with extra weight around the waist • Anxiety or depression • Sleep apnoea (when breathing stops for short periods of time while asleep) • Cysts in the ovaries .Polycystic ovary syndrome is common diagnosis in women presenting with infertility.Polycystic ovary syndrome is an emerging health problem during adolescence therefore promotion of healthy lifestyles and early interventions are required to prevent future morbidities  Yoga module is a complete prescription for the healthy body and mind which can destroy the root cause of Polycystic ovary syndrome i.e., obesity and stress. Obesity and 2 | P a g e stress disturb normal hypothalmo - pituitary – ovarian axis leads to insulin resistance produce stage of hyperandrogenism due to which somatic symptoms of Polycystic ovary syndrome Yoga is a great stress buster stress in women life can even lead to an unwanted weight gain. Entering into peaceful state lowers the production of the stress hormone cortisol which is one of the most important causes for storage of fat in the body . 
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