| 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
|
|
|
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
|
|
|
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
|
|
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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 |
|
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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 studyUterine 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. |