| CTRI Number |
CTRI/2025/09/094441 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in treating fibroid |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic medicine in alleviating the symptoms of intramural fibroid in women of age group 18-40 years-A Prospective, Single arm
clinical study |
| 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 Anjali Dayal |
| Designation |
Junior Resident (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South DELHI 110024 India |
| Phone |
9315003508 |
| Fax |
|
| Email |
anjalidayal99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bipin Jethani |
| Designation |
HOD (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South DELHI 110024 India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anjali Dayal |
| Designation |
Junior Resident (Department of Homoeopathic Philosophy) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Philosophy,Room no-110, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi
South DELHI 110024 India |
| Phone |
9315003508 |
| Fax |
|
| Email |
anjalidayal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital , B Block, Defence Colony, New Delhi - 110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital , B Block, Defence Colony, New Delhi - 110024 |
| Type of Sponsor |
Government 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 Anjali Dayal |
Nehru Homoeopathic Medical College and Hospital |
OPD 2 ,Gynaecology Project OPD, B Block, Defence Colony, New Delhi - 110024 South DELHI |
9315003508
anjalidayal99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of Nehru Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D251||Intramural leiomyoma of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
In this study, the intervention will consist of individualized homoeopathic treatment prescribed on the basis of detailed case taking, analysis, evaluation, and repertorisation in accordance with Hahnemann’s guidelines (§83–§104, Organon of Medicine). The final remedy will be selected after consulting standard Homoeopathic Materia Medica, with miasmatic analysis taken into consideration where indicated. Medicines will be procured from the pharmacy of Nehru Homoeopathic Medical College and Hospital, or GMP-certified sources if unavailable. Remedies will be administered in centesimal (C) or LM potencies via oral route depending on the susceptibility and clinical condition of the patient.The repetition and potency will be decided individually, based on severity of symptoms, susceptibility, and response to treatment.Patient will be called for follow up after every 15 days. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Well diagnosed case of intramural uterine fibroid less than 5cm with clinical signs and symptoms along
with Ultrasonography
2 Female Patients aged 18-40 yrs of age
3 Patients who give written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Patients with complications of uterine fibroids
2 Substance abuse or dependence.
3 Patients of malignancy
4 Patients who are terminally ill and/or under immunosuppressive treatment
5 Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illness
affecting quality of life/any organ failure.
6 Patient unable to comply with the study protocol (including psychiatric diseases).
7 Pregnant ladies
8 Unwilling to take part and not giving written consent to join the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate improvement in symptoms of intramural fibroid using changes in UFS QOL scores
before and after the treatment with individualized Homoeopathic medicine. |
The scoring will be conducted at baseline and at 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in size of uterine fibroid at the end of treatment using ultrasonography |
The size of fibroid will be assessed by ultrasonography at baseline & at 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
13/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The present study titled “Effectiveness of Individualised Homoeopathic Medicine in Alleviating the Symptoms of Intramural Fibroid in Women of Age Group 18–40 Years – A Non-randomised, Prospective, Single Arm, Clinical Study” is designed to evaluate the role of individualized homoeopathic medicines in symptomatic relief of intramural fibroids. Uterine fibroids are the most common benign tumors in women of reproductive age, with intramural fibroids being the most frequent subtype. Conventional management, including surgery, hormonal therapy, and uterine artery embolization, is often associated with adverse effects, high cost, and limitations in preserving fertility. Since existing studies on fibroids in homoeopathy are limited and most have not focused exclusively on intramural fibroids, there is a need for structured clinical evaluation in this group.
The primary objective of this study is to assess the improvement in symptoms using the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) scale before and after homoeopathic treatment. The secondary objectives include evaluating changes in the size of the fibroid through ultrasonography and identifying the most frequently indicated homoeopathic remedies. This is a non-randomised, prospective, single arm clinical study with a sample size of 40 patients, calculated using Cochran’s formula with adjustment for a 10% dropout rate. The duration of the study will be 12 months, including six months of enrollment and six months of follow-up.
Eligible participants will be women aged 18–40 years with ultrasonographically confirmed intramural fibroids less than 5 cm in size, presenting with symptoms and willing to give informed consent. Cases with complications, malignancy, severe systemic illness, psychiatric disorders, or pregnancy will be excluded. Individualised homoeopathic medicines will be prescribed after detailed case taking and repertorization, in potencies suited to the patient’s susceptibility. Outcomes will be measured primarily by change in UFS-QOL scores and secondarily by change in USG findings. Data will be analyzed using the intention-to-treat approach, and statistical significance will be set at p < 0.05.
The study will be conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi. Pharmacovigilance will be ensured throughout the trial, with all adverse events documented and reported. This study aims to provide evidence on whether individualized homoeopathic medicines can offer a safe, effective, and non-invasive treatment option for alleviating the symptoms of intramural fibroids, thereby improving the quality of life in affected women. |