| CTRI Number |
CTRI/2025/10/095908 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving Irregular Periods and Fertility in Women with Polycystic Ovary Syndrome Using Non -Invasive Techniques |
|
Scientific Title of Study
|
Effects Of Non-invasive Intervention in Oligomenorrhea and Infertility in Poly Cystic Ovary Syndrome Women of Reproductive Age |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saleha Khan |
| Designation |
PhD Scholar |
| Affiliation |
G.D.Goenka University |
| Address |
Department of Physiotherapy,School of Healthcare and Allied sciences G.D.Goenka University,Sohna,Gurugram
Gurgaon HARYANA 122103 India |
| Phone |
9873897342 |
| Fax |
|
| Email |
220100601001.saleha@gdgu.org |
|
Details of Contact Person Scientific Query
|
| Name |
Tabish Fahim |
| Designation |
Associate professor |
| Affiliation |
G.D.Goenka University |
| Address |
Department of Physiotherapy,School of Healthcare and Allied sciences
Gurgaon HARYANA 122103 India |
| Phone |
9718481337 |
| Fax |
|
| Email |
tabish.fahim@gdgu.org |
|
Details of Contact Person Public Query
|
| Name |
Tabish Fahim |
| Designation |
Associate professor |
| Affiliation |
G.D.Goenka University |
| Address |
Department of Physiotherapy,School of Healthcare and Allied sciences
Gurgaon HARYANA 122103 India |
| Phone |
9718481337 |
| Fax |
|
| Email |
tabish.fahim@gdgu.org |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,School of Healthcare and Allied sciences G.D.Goenka University,Sohna,Gurugram 122103 Haryana,India |
|
|
Primary Sponsor
|
| Name |
Saleha Khan |
| Address |
Department of Physiotherapy,School of Healthcare and Allied sciences
G.D.Goenka University,Sohna,Gurugram,122103,Haryana,India |
| 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 |
| DrTabish Fahim |
Laadlee Gynae and Ferility Clinic |
Above Apollo Pharmacy Sector 110
Noida Gautam Buddha Nagar UTTAR PRADESH |
09718481337
tabish.fahim@gdgu.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Waves Women Empowerment Trust |
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 |
Medical treatment |
office working females/Housewives
age 18-35 |
| Intervention |
Relaxation exercise
Aerobic training
core strengtehing exercise
visceral manipulation |
office workin females/Housewives
age 18-35
two times in a week
for 12 weeks approx 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosis of PCOS with a history of attempting to conceive for more than a year
Presence of irregular or painful periods |
|
| ExclusionCriteria |
| Details |
Hypertension, Diabetes or any other chronic Disease
Neurological or Cardiovascular disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
fertility hormone
pain
menstural regularity
Body Mass Index
Quality of life |
BEFORE GIVING THE INTERVENTION AND AFTER 12 WEEKS OF INTERVENTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
04/11/2025 |
| 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="0" 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
|
Procedure: Women diagnosed with Polycystic Ovary Syndrome will be assessed using a screening performa. Women who met the inclusion criteria and gave their consent to participate in the study protocol will be recruited. Women will then be randomly assigned to the four groups using computerized randomization technique. Pre and post assessment will be performed for the following variables. Menstrual Regularity: Assessed at baseline and at post-treatment follow-up. Participants will self-monitor their menstrual cycles using a standardized menstrual diary throughout the study period. Regularity will be defined as cycles occurring every 21–35 days over at least two consecutive months. Menstrual Pain: Measured using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).VAS scores will be recorded pre-intervention and post-intervention. Menstrual regularity: will measure at initial presentation and post treatment follow up. Menstrual cycle will self-monitored by subjects using a standardized menstrual diary. Body Mass Index (BMI): BMI is calculated as: the ratio of body weight in kilograms to the square of the height in meters where in height will measure to 0.5cm using calibrated stadiometer and body weight will measure using calibrated clinical scale to the nearest 0.01 kg. Measurements will be taken with participants wearing light clothing and no shoes. Fertility Parameters: Anti-Müllerian Hormone (AMH) levels will be used as a marker of ovarian reserve. Blood samples for AMH testing will be collected pre- and post-intervention under standardized conditions. Quality of life: Evaluated using standardized tools: Depression, Anxiety and Stress Scale – 21 (DASS-21), Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ).
| Experimental groupA Office going/sitting job | Control group B Office going /sitting job | Experimental group C Home maker | Control group D homemaker | | Core strengthening ex Cat and camel(5+5repetion with 30 second hold ,10 minutes) | Medical management | Core strengthening ex Cat and camel(5+5repetion with 30 second hold ,10 minutes) | Medical management | | Relaxation ex Contract and relax selected group of muscles Jacobson technique 10 minutes,deep breathing ex | | Relaxation ex Contract and relax selected group of muscles Jacobson technique 10 minutes,deep breathing ex | | | Aerobic ex 20 minutes on treadmill with 5mph speed with 10%grade | | Aerobic ex 20 minutes on treadmill with 5mph speed with 10%grade | | | Visceral manipulation Uterus mobilisation for 10 minutes | | Visceral manipulation Uterus mobilisation for 10 minutes | | |