| CTRI Number |
CTRI/2025/02/081030 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
INDIVIDUALIZED HOMOEOPATHIC MEDICINE Vs FOLLICULINUM IN
PCOS |
|
Scientific Title of Study
|
ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE Vs FOLLICULINUM IN MANAGEMENT
OF POLYCYSTIC OVARIAN SYNDROME |
| 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 Soni Devi |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital lucknow |
| Address |
Department of Homoeopathic Materia Medica ,OPD no 9,State National Homoeopathic Medical College and Hospital,Viraj Khand 1,Gomti Nagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9456995862 |
| Fax |
|
| Email |
sonipatel1659@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Srivastava |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Forensic Medicine and Toxicology,State National Homoeopathic Medical College and Hospital,Viraj Khand 1,Gomti Nagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9810150710 |
| Fax |
|
| Email |
mansisrivastava.roli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soni Devi |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Homoeopathic Materia Medica ,OPD no 9, State National Homoeopathic Medical College and Hospital,Viraj Khand 1,Gomti Naga
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9456995862 |
| Fax |
|
| Email |
sonipatel1659@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Soni Devi |
| Address |
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow 226010 |
| 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 Soni Devi |
State National Homoeopathic Medical College and Hospital Lucknow |
Department of Homoeopathic Materia Medica ,OPD 9
Lucknow
UTTAR PRADESH |
9456995862
sonipatel1659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
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 |
Folliculinum |
Folliculinum will be given to the patients selected by computer generated randomization. Doses and duration of repetition will be according to the necessity of the case. Route of administration will be oral. |
| Intervention |
Homoeopathic Individualized Medicine |
Homoeopathic individualized medicine will be selected based on the totality of symptoms and will be given to the patients selected by computer generated randomization. Potency selection based on the susceptibility of the patient, minimum dose will be given. Repetition based on the severity of the disease. Route of administration-oral. In addition to this, placebo will be given to the patients in this group till final assessment of the case. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Women between age of 18 to 35 years
2 Married & Unmarried females
3 Diagnosed cases of PCOS according to Rotterdam criteria 2003 Criteria should include two of the following three criteria Chronic anovulation Hyperandrogenism Polycystic ovaries
4 Body Mass Index BMI between 18.5 – 40 kg/m2
5 Participants willing to adopt healthy diet and to take regular exercise at least 30 minutes of exercise for at
least 5 days a week
6 Patients with ability to give informed consent with comply with study |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating women
2 Below the age of 18 and above the age of 35 years
3 Women with other hormonal disorders example Cushing syndrome congenital adrenal hyperplasia
4 Women taking hormonal medicines Birth control pills fertility medicine
5 History of intake of drugs Aldactone/Metformin or history of oral pills OCP use or intake of drugs known to interfere with carbohydrate metabolism 4 weeks prior to enrollment
6 Cases with any systemic disease HTN DM Thyroid or any Immune Suppressive Disease
7 Patients who can not make regular follow up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine whether there is a significant difference between the effectiveness of
Folliculinum and Individualized Homoeopathic Medicine in PCOS Management. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the condition of ovaries by pelvic USG and the Modified Naranjo Criteria for Homoeopathy (MONARCH) to access the likelihood of casual relationship between Homoeopathic Medicine and clinical outcome. |
6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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 - NO
|
|
Brief Summary
|
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive-aged women, affecting approximately 5% to 20% of women of reproductive age.It is characterized by hormonal imbalances, irregular menstrual cycles, and metabolic disturbances. A recent study found that PCOS was the most common underlying etiology in adolescents hospitalized with abnormal uterine bleeding (AUB) and menorrhagia, accounting for 33% of admissions. Homoeopathy, an individualized system of medicine offers a holistic approach to treating PCOS by addressing the unique system patterns presented by each patient. In homoeopathy, repertories serve as essential tools to identify similimum remedies that best match of totality of symptoms. In the cases in which PCOS causes infertility, FOLLICULINUM medicine improve the quality of eggs and helpful in managing the infertility. A comparative study between individualized homoeopathic medicine and Folliculinum can help establish the efficacy of these treatments in PCOS managemen’This study can provide insights into the most effective personalized treatment approach for PCOS patients. |