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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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