| CTRI Number |
CTRI/2025/08/093592 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Cold Hip Bath on PCOS |
|
Scientific Title of Study
|
Effect of Cold Hip Bath on Ovarian Morphology among Females with Polycystic Ovarian Syndrome: A Randomized Controlled Trial |
| Trial Acronym |
CHB PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJESHWARI SWAMINATHAN |
| Designation |
PG SCHOLAR CLINICAL NATUROPATHY |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9324086670 |
| Fax |
|
| Email |
dr.rajeshwari20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SARASWATI TEWANI |
| Designation |
PROFESSOR HOD DEPARTMENT OF NATUROPATHY |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9131588356 |
| Fax |
|
| Email |
jyotitewanimgps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJESHWARI SWAMINATHAN |
| Designation |
PG SCHOLAR CLINICAL NATUROPATHY |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9324086670 |
| Fax |
|
| Email |
dr.rajeshwari20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
|
|
Primary Sponsor
|
| Name |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Lake Road Bairagarh Bhopal MP 462030 |
| Type of Sponsor |
Private medical college |
|
|
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 Rajeshwari Swaminathan |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Room No BS 22 Department of Research Lake Road Bairagarh
Bhopal
MADHYA PRADESH |
9324086670
dr.rajeshwari20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
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 |
| Intervention |
COLD HIP BATH |
Patients will take Cold hip bath in the morning on an empty stomach for 90 days, excluding days of menstruation. |
| Comparator Agent |
Risk Reduction Counselling |
Females with PCOD will be counselled on dietary modifications and physical activity. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Females diagnosed with PCOS according to Rotterdam Criteria- any two of the three symptoms should be present
a. Increased serum concentration of androgens-hyperandrogenemia or the presence of clinical signs related to androgen excess - hyperandrogenism
b. Oligoamenorrhoea or anovulation means more than 35 days or less than 8 periods in a year
c. Ultrasonography features characteristics of polycystic ovaries- more than 20 ovarian follicles with a 2 to 9 mm diameter in either ovary, or an ovarian volume of more than 10 mL in either ovary or both.
2. Subjects willing to participate in research and ready to sign the informed consent.
3. Subjects willing to take cold hip bath.
|
|
| ExclusionCriteria |
| Details |
1. Women with thyroid disorders, hyperprolactinemia, and structural anomalies of the reproductive system.
2. Women who are not willing to consent to the study.
3. Women taking OCDs or on ICDs, insulin-sensitising medications, or any hormonal pills for the past 3 months.
4. Women adhering to a strict exercise, alternative medical treatments or dietary regimen for the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovarian Morphology |
Baseline and after 90 days excluding menstrual days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual Frequency |
Baseline and after 90 days excluding menstrual days |
| Anthropometric measures BMI and WHR |
Baseline and after 90 days excluding menstrual days |
| Hirsutism by The mFG, or modified Ferriman-Gallwey scoring system |
Baseline and after 90 days excluding menstrual days |
| Depression Anxiety Stress Scale-21 |
Baseline & after 90 days excluding menstrual days |
| Polycystic Ovarian Symptom Quesionnaire-Self Administered |
Baseline & after 90 days excluding menstrual days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.rajeshwari20@gmail.com].
- For how long will this data be available start date provided 14-11-2027 and end date provided 14-11-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
PCOS is a common gynecological disorder characterized by irregular menstruation and/or multiple cysts in one or more ovaries associated with high androgen levels in the body. COLD HIP BATH is one of the basic hydrotherapeutic modalities, part of naturopathy, proven to enhance parasympathetic activity and regulate autonomic balance, along with influencing the circadian rhythm regulation and restoring hormonal balance in various gynecological and obstetrical disorders, along with other naturopathic and yoga therapies. No study focused on the individual role of cold hip bath on PCOS well-being; hence, this study is a prospective randomized controlled trial evaluating the effect of cold hip bath on ovarian morphology as the primary outcome and menstrual frequency, hirsutism, BMI and WHR, psychological well-being, and quality of life as the secondary outcomes in 60 females with PCOS for 3 months, with 30 in the intervention group and 30 in the comparison group receiving risk reduction counselling. |