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CTRI Number  CTRI/2024/08/072060 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study The Effect Of Yoga And Naturopathy In Polycystic Ovarian Syndrome  
Scientific Title of Study   An Open Label Randomised Comparative Clinical Study- To Evaluate The Combined Effect Of Yoga And Naturopathy Techniques In Polycycstic Ovarian Syndrome(Pcos) 
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 JANHVI MAHADEV GOMARE 
Designation  PG SCHOLAR 
Affiliation  Rajiv Gandhi University Of Health Science , Banglore 
Address  Room No. 12, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, 41/E, Lalithadripura, Mysuru 570028 Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  8805854433  
Fax  08212548360  
Email  janhvimg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Sudhakar Reddy 
Designation  Professor and Head 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Room No. 12, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, 41/E, Lalithadripura, Mysuru 570028 Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  9961483919  
Fax  08212548360  
Email  drpsreddy05@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr P Sudhakar Reddy 
Designation  Professor and Head 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Room No. 12, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, 41/E, Lalithadripura, Mysuru 570028 Mysore KARNATAKA 570028 India

Mysore
KARNATAKA
570028
India 
Phone  9961483919  
Fax  08212548360  
Email  drpsreddy05@yahoo.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura Road, Mysuru- 570028 
 
Primary Sponsor  
Name  DR. JANHVI GOMARE 
Address  Department of PG Studies in Swasthavritta, JSS Ayurveda Medical College and Hospital, 41/ E, Lalithadripura Road, Mysuru, Karnataka, 570028 
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 JANHVI GOMARE  JSS Ayurveda College and Hospital  Room NO. 12, Department of Swasthavritta OPD, 41/ E, Lalithadripura Road, Mysuru, Karnataka, 570028 Mysore KARNATAKA Mysore KARNATAKA
Mysore
KARNATAKA 
8805854433

janhvimg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS AYURVEDA MEDICAL COLLEGE  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: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Neutral Hip Bath (Procedure Reference: Naturopathy , Procedure details: Neutral hip bath for 20 minutes,for 3 months everyday evening except during menstruation period.)
2Comparator ArmProcedure-yogasanas (Procedure Reference: bks iyengar, Procedure details: Selected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Age group 18-40 years old females.
Subjects diagnosed with PCOS as defined by Rotterdam criteria. 
 
ExclusionCriteria 
Details  Subjects below 18 years of age and above 40 years old
Subjects already on other drug treatment for PCOS like OC Pills etc
Subjects with known cases of systemic disorders like hypertension, renal disorders,
and metabolic disorders like diabetes mellitus, thyroid dysfunction.
Subjects with ovarian fibroids, carcinoma.
Pregnant women and lactating mothers
Subjects who are not willing to participate in the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
REGULARITY OF MENSTRUAL CYCLE AND REDUCTION OF OVARAIN CYST SIZE  31st day and 61st day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction Ferriman-Gallwey Score , BMI (Body mass index), Investigator Global Assessment Of Acne.  31st day, 61st day, 91st day 
 
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 
Date of First Enrollment (India)   21/08/2024 
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="3"
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 ovarian syndrome or PCOS is a multifactorial and polygenic condition. PCOS is one of the most common Hormonal disorders among women in reproductive age group. The incidence varies between 0.5 to 4% more common amongst infertile women. It is prevalent in young reproductive age group 20 to 30%. Polycystic ovary may be seen in about 20% of normal women1. In this condition, the ovaries of the woman may become enlarged and they may develop numerous harmless fluids filled sacs (follicles). These follicles are underdeveloped sacs which are meant for developing eggs – in PCOS, these follicles fail to release the matured eggs. Following unhealthy Food patterns, sedentary lifestyle, hormonal imbalance, stress and insulin resistance leads to PCOS. Treatment is primarily targeted to correct the biochemical abnormalities, weight reduction, management of hyperandrogenemia, metabolic syndrome, hyperinsulinemia, endometrial hyperplasia, ovulation induction, insulin sensitizers and surgery which is expensive as well as can lead to complications2. The yoga therapy or ‘yoga chikitsa’ refers to the treatment of diseases by means of yogic exercises which may be physical or mental or both. This mode of treatment has been practiced in India from very ancient times. Yoga aims at obtaining relief from pain and suffering. Konasanas are the sets of asanas help to develop and tone the muscles, has favorable effect on the abdominal and pelvic organs as they get compression alternatively and aids good circulation. Naturopathy is the system in which natural elements are used such as panchamahabhuta are used to treat the diseases3. Hydrotherapy is one among the naturopathy treatment which elements the morbid matter and improves the circulation to the organs of the body. It is a need of hour to find out the natural, cost effective and safe methods to treat the PCOS. With this background, the present study is designed to evaluate the combined effect of selected yoga and naturopathy techniques in PCOS.


Group A 20 Subjects and Group B 20 Subjects


Intervention of the study:-

GROUP A

Selected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning except during menstruation period.

Asanas: - Practicing following asanas 2 rounds each minimum 30 seconds holding in final posture -Parshvakonasana, Parivritta Konasana, Trikonasana, Parivritta Trikonasana, Upavishta Konasana, Suptakonasana, Baddhakonasana.

GROUP B

Selected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning along with Neutral hip bath for 20 minutes everyday evening except during menstruation period.

Assessment schedule:  

subjects are assessed on 0th day, 31st day, 61st day and 91st day.


 
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