| CTRI Number |
CTRI/2024/05/066948 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diet, Yoga and sleep pattern] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative analysis of composite lifestyle intervention and conventional methods in managing obese PCOS related hormonal and weight, stress in subjects with PCOS. |
|
Scientific Title of Study
|
A randomized, Single center, Single-blind, Parallel, Two-Arm, Comparative analysis of composite lifestyle intervention and conventional methods in managing obese PCOS related hormonal and metabolic parameters in subjects with PCOS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| Observation Study |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakthivel |
| Designation |
Consultant Endocrinologist |
| Affiliation |
Hormone Clinic |
| Address |
Hormone Clinic
Sivasakthi nursing home
Thillainagar
Trichy
Tiruchirappalli
TAMIL NADU
620018
India |
| Phone |
8508284662 |
| Fax |
|
| Email |
revathi890ph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthivel |
| Designation |
Consultant Endocrinologist |
| Affiliation |
Hormone Clinic |
| Address |
Hormone Clinic
Sivasakthi nursing home
Thillainagar
Trichy
Tiruchirappalli
TAMIL NADU
620018
India |
| Phone |
8508284662 |
| Fax |
|
| Email |
revathi890ph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Dheeptha Sundar |
| Designation |
Clinical Dietician |
| Affiliation |
Hormone Clinic |
| Address |
Hormone Clinic
Sivasakthi nursing home
Thillainagar
Trichy
Tiruchirappalli
TAMIL NADU
620018
India |
| Phone |
8610269340 |
| Fax |
|
| Email |
sabarinathan200107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hormone Clinic,
Sivasakthi nursing home,
Thillainagar,
Tiruchirappalli, Tamilnadu, India-620018 |
|
|
Primary Sponsor
|
| Name |
DrSakthivel |
| Address |
Hormone Clinic,
Sivasakthi nursing home,
Thillainagar,
Trichy |
| 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 Sakthivel |
Hormone Clinic |
1, Second floor, Endocrinology department, Hormone clinic, Sivasakthi Nursing Home,
Thillainagar,
Tiruchirappalli-620018.
Tiruchirappalli
TAMIL NADU |
8508284662
revathi890ph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Athma Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional |
The subject will involve in existing PCOS medications |
| Intervention |
Life style modification |
The subjects will involve in Proper Diet, Sleep pattern, Yoga and exercise plan |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age Range: Participants aged 20 to 40 years (inclusive). Subject must meet age requirements at the time of signing the initial study specific informed consent. In addition, the subject’s race and ethnicity should be documented.
ï‚·Gender: Females, Non-Pregnant or Non-lactating Female and Child bearing potential women
Women of Child bearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to the randomization.
ï‚·Women of child barring potential are to be subjected to contraceptive techniques to refrain from pregnancy via oral, hormonal, or other contraceptive methods.
ï‚·Diagnosis of PCOS: Participants must have a confirmed diagnosis of PCOS based on established criteria (e.g., Rotterdam criteria). Hypothyroid adequately replaced.
Controlled Diabetic, Pre diabetes and non diabetic females are considered for the study (hbA1c≤8)
Body Mass Index (BMI):Each subject should have a Body mass index (BMI)value less than or equal to 35.0kg/m2 but greater than 23.0kg/m2. All weight values are to be reported according to the scale’s precision (I.e. the nearest tenth or hundredth 72.3 kg or 72.25kg). The subject’s height is to be reported in centimeters near to tenth. Each subject’s BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is should be reported to the nearest tenth (I.e. 26.3kg/m2)
ï‚·Sleep routine: sleep cycle should be at least 5 to 8 hours/ day.
ï‚·Smoking status: The subject should be non-smokers, non-alcoholic or not using any smoking or alcohol or any tobacco related products for more than a year.
ï‚·Willingness to Participate: Individuals willing to follow the protocol requirements and comply with protocol restrictions.
ï‚·Consent: Participants should have adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate.
ï‚·All the candidates are to be examined by the chief medical practitioner and other parameters corresponding to the clinical diagnosis are evaluated.
ï‚·If warranted other tests or examinations can be done at the discrepancy of the investigator. |
|
| ExclusionCriteria |
| Details |
ï‚·Age: Adult women in the age group of 20 to 40 who pregnant.
ï‚·Pregnancy and Lactation:
ï‚·Participants who are currently pregnant or planning to become pregnant during the study period.
ï‚·Participants who are currently lactating.
ï‚·B- HCG positive within 15 days of start of study or prestudy medical examination are to be excluded
Menopausal Status: Women in menopause. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will recruit the 120 subjects to assess the PCOS hormonal parameters at 24 weeks |
This study was undertaken to explore the influence and thyroid function, insulin resistance, body weight, BMI, and lipid profile as secondary outcomes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study was undertaken to explore the influence & enhancement of thyroid function, insulin resistance, body weight, BMI, & lipid profile as secondary outcomes at 12 weeks |
The assessment of improvements in inflammatory response, sleep patterns, subjective well-being scores, skin, & hair conditions (specifically hirsutism), & parameters associated with menstruation such as stomach pain, abdominal bloating, & period cramps were considered as secondary measures. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
21/05/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
|
STUDY DRUG: Conventional Method: Any Oral PCOS drugs Interventional Method: Lifestyle Modification (Diet, Yoga, Exercise and Sleep) The innovator and/or inventional method may contain Diet (proper diet chart which is given by dietician), Yoga and exercise and sleep pattern In the conventional method, the participant will take any Oral PCOS drugs to treat their PCOS with regular food chart with regular activities. |