| CTRI Number |
CTRI/2024/09/073227 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
yoga and Ayurvedic diet for PCOS |
|
Scientific Title of Study
|
Yoga along with Ayurvedic diet for the management of Polycystic Ovary Syndrome: Feasibility Randomised Comparative Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibhuti Samarth Rao |
| Designation |
Visting PhD Student |
| Affiliation |
Medical Research Centre- Kasturba Health Society, |
| Address |
Floor 5, Division of Endocrinology and Metabolic Disorders- Lifestyle Modifications and Yoga Module, 17, Khandubhai Desai Road, Puranmal Hotel Lane, Vile Parle (w)
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9972060989 |
| Fax |
|
| Email |
drvibhutirao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shobha A Udipi |
| Designation |
Research Director and Head |
| Affiliation |
Medical Research centre- Kasturba Health Society, |
| Address |
Floor 5, Integrative Nutrition and Ayurceuticals, 17, Khandubhai Desai Road, Puranmal Hotel Lane, Vile Parle (w)
Mumbai
MAHARASHTRA
400056
India |
| Phone |
02226715147 |
| Fax |
|
| Email |
drshobhaudipi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhuti Samarth Rao |
| Designation |
Visting PhD Student |
| Affiliation |
Medical Research centre- Kasturba health Society, |
| Address |
Floor 5, Division of Endocrinology and Metabolic Disorders- Lifestyle Modifications and Yoga Module, 17, Khandubhai Desai Road, Puranmal Hotel Lane, Vile Parle (w)
MAHARASHTRA
400056
India |
| Phone |
9972060989 |
| Fax |
|
| Email |
drvibhutirao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Centre-
Kasturba Health Society, 17, Khandubhai Desai Road, Puranmal Hotel Lane, Vile Parle (w), Mumbai 400056 |
|
|
Primary Sponsor
|
| Name |
Vibhuti Samarth Rao |
| Address |
Floor 5, Division of Endocrinology and Metabolic Disorders- Lifestyle Modifications and Yoga Module, 17, Khandubhai Desai Road, Puranmal Hotel Lane, Vile Parle (w), Mumbai 400056 |
| Type of Sponsor |
Other [Self- PI] |
|
|
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 Ulka Natu |
Nest Maternity and Surgical Hospital |
OPD 2, Third Floor, Obstetrician and Gynecology Department, Behind SBI, Off Gokhale Road, Naupada, Thane (West)
Mumbai
MAHARASHTRA |
9819131469
ulka.natu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inter System Biomedica Ethics Committee (ISBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Modern dietary and lifestyle counselling | Personalized modern dietary consultation along with usual care as suggested for PCOS. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Yoga therapy and Ayurvedic dietary consultation , Pathya/Apathya:yes, Pathya:Follow Kaphakara ahara vihara, Apathya:Kapha pradhana tridoshaja prakopa ahara vihara |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 35 years diagnosed with PCOS based on the Rotterdam Criteria in the past 1 year
with a BMI of 23 to 29.9, not taking any pharmacological, nutritional, or herbal treatments for PCOS, and being able to read and understand basic English.
|
|
| ExclusionCriteria |
| Details |
Currently pregnant, less than 6 weeks postpartum,
diagnosed with severe anaemia, unwilling or unable to provide consent & adhere to the protocol, unable to travel to study sites for data collection, known cases of liver, kidney, cancer, and cardiovascular conditions, following any special diets such as time-restricted fasting, ketogenic diet, and vegan diet, known cases of gluten or lactose intolerance or any food allergy, on medication for metabolic, psychological disorders and other endocrine disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility (recruitment, adherence, acceptability, adverse events, appropriateness of outcome measures and participants experiences) |
During and at the end of the trial at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric (Waist-to-hip ratio in cm, Weight in kg,
BMI, Percent body fat in %, Visceral fat area in cm2,
Percent subcutaneous fat in %, Resting metabolism and Skeletal muscle mass in kg), Quantitative, qualitative assessment of dietary habits including diet-related behavioural modification, Stress level, Sleep Quality, Obesity-related quality of life, and PCOS-related quality of life.
|
Before and after the trial at 0 and 12 weeks respectively |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/09/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The overall aim of this study is to examine the feasibility of the trial procedures and to investigate any changes in objective and subjective outcome measures when using combined Ayurvedic diet and yoga therapies against modern dietary and lifestyle suggestions in women with PCOS. |