| CTRI Number |
CTRI/2025/09/095088 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
SCOPE OF HOMEOPATHY IN PCOD |
|
Scientific Title of Study
|
AN INVESTIGATIVE APPROACH TO PCOS: CORRELATION OF DIAGNOSTIC MARKERS WITH CONSTITUTIONAL HOMEOPATHIC REMEDY SELECTION |
| 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 SANDEEPKUMAR RASIKLAL VAGHELA |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLLEGE, RAJKOT. |
| Address |
778, AMBIKANAGAR, G.H.B. SAYAN ROAD, AMROLI, SURAT.
Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat 360002.
Rajkot
GUJARAT
394107
India |
| Phone |
9638638738 |
| Fax |
|
| Email |
DR.SANDIPVAGHELA@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR URMILA BHALGARIYA |
| Designation |
ASSITANT PROFESSOR, DEPARTMENT OF PRACTICE OF MEDICINE |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLLEGE, RAJKOT. |
| Address |
TO, AMBECHA, TA. MALIYA HATINA, DIST. JUNAGADH.
Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat 360002.
Rajkot
GUJARAT
362245
India |
| Phone |
9409249004 |
| Fax |
|
| Email |
drurmilabhalgariya94092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANDEEPKUMAR RASIKLAL VAGHELA |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLLEGE, RAJKOT. |
| Address |
778, AMBIKANAGAR, G.H.B. SAYAN ROAD, AMROLI, SURAT.
Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat 360002
Rajkot
GUJARAT
394107
India |
| Phone |
9638638738 |
| Fax |
|
| Email |
DR.SANDIPVAGHELA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| RAJKOT HOMEOPATHIC MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
SAINATH HOSPITAL |
| Address |
Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat 360002 |
| 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 |
| DRSANDEEPKUMAR RASIKLAL VAGHELA |
SAINATH HOMEOPATHIC HOSPITAL |
103, DEPARTMENT OF GYN AND OBS, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat 360002
Rajkot
GUJARAT |
9638638738
DR.SANDIPVAGHELA@GMAIL.COM |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Research- Rajkot Homeopathic Medical College [RHMC], PARUL UNIVERSITY |
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 |
AN INVESTIGATIVE APPROACH TO PCOS: CORRELATION OF DIAGNOSTIC MARKERS WITH CONSTITUTIONAL HOMEOPATHIC REMEDY SELECTION |
Polycystic Ovarian Disease (PCOD) is a hormonal disorder characterized by the development of multiple fluid-filled sacs (cysts) within the ovaries. This condition arises due to disturbances in endocrine function, primarily involving excessive androgen (male hormone) production by the ovaries, which impacts menstrual regulation, fertility, and various metabolic processes.From a homoeopathic perspective, constitutional treatment aims to correct the underlying dysfunction by regulating glandular activity, restoring hormonal balance, and promoting the natural dissolution of ovarian cysts. This approach can lead to normalized ovulation, menstrual regularity, and potentially improved fertility outcomes without the use of conventional hormone therapy or surgery. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Clinically diagnosed patient.
15 - 45 years age female were included irrespective of their caste, religion, socioeconomic status, marital status, parity, and duration of illness.
|
|
| ExclusionCriteria |
| Details |
Those who took oral contraceptives, steroid hormones, 3 months before the study
Taking hormone replacement therapy
Complicated with androgen producing malignancy,
Cushing syndrome or acromegaly
Thyroid dysfunction
• Diabetes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There Is A Significant Difference
In The Treatment Outcomes For
PCOD, Individuals Receiving
Homoeopathic Intervention. |
There Is A Significant Difference In The
Treatment Outcomes For PCOD symptoms and The Patient
Will Undergo Follow-Up Visits Every 15 To 30
Days, During Which There May Be Clinical
Improvements after 12 weeks And Potential
Changes In The Rotterdam criteria. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A Significant Improvement In endocrine functions Results Accompanies Decrease In
The Rotterdam criteria Offering
Insights Into The Etiology Of PCOD. |
USG Will Be Performed after 12
weeks On Average,and other diagnostic marker may be repeat as per the need, And The Scale Will Be Applied In Every Follow-Up. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="11"
Days="29" |
|
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 is a common hormonal disorder affecting women of reproductive age. It is characterized by irregular ovulation, increased androgen levels, and multiple ovarian cysts. The condition is linked with insulin resistance, obesity, and genetic factors, leading to menstrual irregularities, infertility, and metabolic complications.
The study aims to evaluate the role of individualized homeopathic medicines in managing PCOS. The hypothesis is that constitutional remedies may improve hormonal balance and clinical symptoms.
This prospective, open label, non randomized clinical study will include 50 female patients aged 15 to 45 years diagnosed with PCOS based on Rotterdam criteria. Patients will be recruited from the outpatient departments and camps of Sainath Homeopathic Hospital, Rajkot.
Treatment will involve individualized homeopathic prescriptions selected through case taking, repertorization, and materia medica confirmation. Follow up will be carried out at intervals of 15 days. Outcomes will be assessed using Rotterdam diagnostic markers including ovulation, androgen levels, and ultrasound findings.
The study seeks to establish the correlation between homeopathic constitutional remedies and clinical improvement in PCOS, with the broader aim of validating the role of homeopathy in managing endocrine and reproductive disorders. |