| CTRI Number |
CTRI/2025/11/097696 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find effect of individualized Homoeopathic medicine in treatment of Uterine Fibroid and improving their quality of life. |
|
Scientific Title of Study
|
Effectiveness Of Constitutional Homoeopathic Medicines In The Management Of Uterine Fibroid : A Clinical Study Using UFS-QOL |
| 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 HRITHIK MS |
| Designation |
Junior Resident, Department of Organon of Medicine |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine , White Memorial Homoeo Medical College and Hospital , Attoor , Veeyanoor Po , Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
09600903298 |
| Fax |
|
| Email |
sudheerhrithik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ISAAC JOSE |
| Designation |
Associate Professor |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine , White Memorial Homoeo Medical College and Hospital , Attoor , Veeyanoor Po , Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9061888999 |
| Fax |
|
| Email |
issaaac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ISAAC JOSE |
| Designation |
Associate Professor |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Organon of Medicine , White Memorial Homoeo Medical College and Hospital , Attoor , Veeyanoor Po , Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9061888999 |
| Fax |
|
| Email |
issaaac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Organon Of Medicine White Memorial Homoeo Medical College And Hospital,Attoor , Veeyanoor PO , Kanniyakumari, Tamil Nadu, India, 629177 |
|
|
Primary Sponsor
|
| Name |
Department of Organon of medicine , White Memorial Homoeopathy Medical college and Hospital |
| Address |
White Memorial Homoeo Medical College And Hospital Attoor , Kanniyakumari , Tamil Nadu 629177 |
| 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 HRITHIK MS |
white Memorial Homoeo Medical College & hospital |
Department of Organon of Medicine , White Memorial Homoeo Medical College and Hospital , Attoor , Veeyanoor Po , Kanniyakumari
Kanniyakumari
TAMIL NADU |
09600903298
sudheerhrithik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE & HOSPITAL ETHICS COMMITTEE WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine |
Participants will receive individualized constitutional homoeopathic medicines selected on basis of symptom similarity, administered in appropriate dose, potency and repetition according to Homoeopathic principles. Follow up will be done every 2to3 weeks , for a minimum of 6 months and quality of life will be assessed at the beginning and the end of the study . |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women of age group from 20 to 45 years are included
Patients already diagnosed with uterine fibroid are included .
Fibroid size less than 7 cm.
symptom severity index score of 40 or higher and Health related quality of life (HRQOL) Scale score of 60 or lower . |
|
| ExclusionCriteria |
| Details |
Complications of fibroid like Torsion .
patients in the peri menopausal / post menopausal phase .
patients associated with any other systemic disorders , Malignancies , SLE , Renal Failure , Diabetes Mellitus and Secondary Hypertension are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of improvement in Quality of life will be done by comparing UFS-QOL Score before and after the treatment. |
Assessment of improvement in Quality of life will be done by comparing UFS-QOL Scores at the beginning and end of 6 months . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/12/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - all data to be provided when needed through email sudheerhrithik@gmail.com
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Uterine fibroids also known as leiomyomas , are common non - cancerous tumors of the uterus that usually affect women in their reproductive years particularly between 30-40 years of age . while many fibroids remains asymptomatic , they can sometimes cause significant health problems such as heavy or irregular menstrual bleeding , pelvic pain , abdominal mass , pressure symptoms like frequent urination or constipation , and even complications such as infertility , miscarriage , or premature labor . conventional treatment options in modern medicine include hormonal therapy , uterine artery embolization , myomectomy and hysterectomy . although these methods may relief symptoms , they often involve side effects , surgical risks and loss of fertility , leading to a growing demand for non - invasive and safer alternatives . Homoeopathy , with its constitutional approach that which considers the patients physical , mental and general characteristics , offers a promising alternative in the management of uterine fibroids . Remedies are selected on the basis of individual symptom patterns rather than just the disease diagnosis . Previous studies and clinical observations suggest homoeopathic medicines can help in reducing symptoms and improving patients overall well being without any adverse effects . However , there is a lack of systematic clinical research focusing specially on the effectiveness of constitutional homoeopathic medicines in fibroid management , especially when measured with standardized quality of life tools .The present study is designed to fill this gap . It will be conducted in as a prospective , single - group clinical study at White Memorial Homoeopathy Medical College and Hospital . A minimum of 30 women patients aged 20-45 years , diagnosed with uterine fibroid less than 7 cm in size , will be included .Patients with severe complications or in post menopausal age will be excluded . Each participants detailed case history will be recorded and constitutional homoeopathic remedies will be prescribed based on symptom similarity . The study will evaluate changes in symptom severity such as heavy bleeding , pelvic pain and pressure related discomfort and overall quality of life using the Uterine Fibroid Symptom And Health Related Quality Of Life Questionnaire .Alongside clinical and ultra sound findings . patients will be followed up regularly for a minimum of six months . Data will be analyzed statistically using paired t test to assess pre and post treatment differences . The expected outcome is significant symptomatic improvement , better quality of life , and evidence supporting the role of constitutional homoeopathic medicines as a non invasive and effective management option for uterine fibroids . |