| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Neutral Hip Bath | (Procedure Reference: Naturopathy , Procedure details: Neutral hip bath for 20 minutes,for 3 months everyday evening except during menstruation period.)
| | 2 | Comparator Arm | Procedure | - | 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 |
|
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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 ASelected 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 BSelected 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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