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CTRI Number  CTRI/2026/02/103749 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Diagnostic 
Study Design  Other 
Public Title of Study   Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana in reducing size of intramural uterine fibroid  
Scientific Title of Study   Assessing the effectiveness of Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana on regression of Intramural Fibroid A Comparative 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  Aaliyafatima Maldar  
Designation  PG student 
Affiliation   
Address  Government Homoepathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaveshwara Nagar Bengaluru Ground floor Room no 22

Bangalore
KARNATAKA
560079
India 
Phone  9606317210  
Fax    
Email  aaliyafatimamaldar23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Renuka S Patil 
Designation  HOD 
Affiliation   
Address  Government Homoepathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaveshwara Nagar Bengaluru Ground floor Room no 22

Bangalore
KARNATAKA
560079
India 
Phone  9606317210  
Fax    
Email  renukasiddrampatil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aaliyafatima Maldar  
Designation  PG student 
Affiliation   
Address  Government Homoepathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaveshwara Nagar Bengaluru Ground floor Room no 22

Bangalore
KARNATAKA
560079
India 
Phone  9606317210  
Fax    
Email  aaliyafatimamaldar23@gmail.com  
 
Source of Monetary or Material Support  
Dr Aaliyafatima Maldar  
 
Primary Sponsor  
Name  Dr Aaliyafatima Maldar  
Address  Government Homoepathic Medical College and Hospital Dr Siddhaiah Puranik road Basaveshwara nagar Bengaluru Ground floor room no 22 
Type of Sponsor  Other [Principal investigator ] 
 
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 Aaliyafatima Maldar   Government Homoepathic Medical College and Hospital   Government Homoepathic Medical College and Hospital Dr Siddhaiah Puranik Road Basaveshwara Nagar Bengaluru Ground floor Room no 22
Bangalore
KARNATAKA 
9606317210

aaliyafatimamaldar23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Homoepathic 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: N850||Endometrial hyperplasia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aurum muriaticum natronatum   To assess the effectiveness of Homoeopathic medicine Aurum muriaticum natronatum on regression of intramural uterine fibroid  
Comparator Agent  Fraxinus americana   To assess the effectiveness of Homoeopathic medicine Fraxinus americana on regression of intramural uterine fibroid  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Subjects who are willing to participate as volunteers in the study and sign the written informed consent.
Newly diagnosed cases of Intramural uterine fibroid.
Subjects between the age group of 25 to 45 years of age.
Intramural uterine fibroid of size up to 5cm. 
 
ExclusionCriteria 
Details  Pregnant and lactating mothers.
Subjects with Hypothyroidism, Hyperthyroidism, Gross developmental defect or congenital abnormalities of the uterus, Pelvic inflammatory diseases, Diabetes mellitus and Hypertension.
Fibroids with severe pain and bleeding with suspicion of acute torsion and other complications which needs immediate surgical intervention.
Subjects who are taking medication from other system of medicine and subjects taking Homoeopathic medicine for the same complaint.
Subjects with Hemoglobin less than 8g/dl 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete regression of intramural uterine fibroid in USG abdomen and pelvis from baseline  Complete regression of intramural uterine fibroid in USG abdomen and pelvis from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  By the end of 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)   26/02/2026 
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   Need for the study
Uterine fibroids are the most common benign growths of the uterus and are the most common benign solid tumors affecting women. They tend to be more prevalent in women who have never given birth (nulliparous) or those experiencing infertility with only one child. These fibroids are predominantly found in the uterine body, with distribution as follows: intramural (75%), subserosal (15%), and submucosal (5%).

A global age period cohort analysis conducted from 1990 to 2019 examined the burden of uterine fibroids, estimating around 9.64 million new cases and a total prevalence of approximately 226.05 million cases globally. In India, it affects approximately 37.65% of individuals in rural areas and about 24% in urban settings. Women in their reproductive years especially those in their 30’s and 40’s are at a higher risk of developing fibroids. Furthermore, research indicates that by the age of 50, nearly 70–80% of women may experience uterine fibroids.

Although the majority of fibroids (approximately 75%) do not present with symptoms, those that are symptomatic can lead to various clinical issues. Common symptoms include abnormal menstrual bleeding such as menorrhagia and metrorrhagia, as well as dysmenorrhea, dyspareunia, subfertility, pelvic pressure, recurrent miscarriages, lower abdominal and pelvic pain, and abdominal distension.

The chosen treatment approach should focus on promoting the regression of Intramural uterine fibroids. Research indicates that homeopathic remedies contribute to a reduction in the size of these fibroids.

Aurum muriaticum natronatum and Fraxinus americana are two such remedies considered in the treatment of uterine fibroid. According to Dr. Burnett, Aurum muriaticum natronatum demonstrates greater effectiveness in treating uterine tumors compared to other remedies. He also referred to Fraxinus americana as a uterine tonic, particularly useful in conditions involving an enlarged or heavy uterus, describing it as “the medicinal pessary”.
Hence, the study is intended to assess the effectiveness of Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana on regression of Intramural uterine fibroid.

RESEARCH QUESTION: Is there any significant difference between the effectiveness of Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana on regression of Intramural uterine fibroid?

NULL HYPOTHESIS (H0): There may not be a significant difference between the effectiveness of Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana on regression of intramural uterine fibroid.

ALTERNATIVE HYPOTHESIS (H1): There may be a significant difference between the effectiveness of Homoeopathic medicines Aurum muriaticum natronatum and Fraxinus americana on regression of Intramural uterine fibroid.
 
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