| CTRI Number |
CTRI/2026/02/103576 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of individualized homoeopathic medicine and fraxinus Americana in the Management of Uterine Fibroid |
|
Scientific Title of Study
|
To Evaluate the Efficacy of Individualized Homoeopathic Medicine VS Fraxinus Americana in the Management of Uterine Fibroid A Randomized controlled Trial |
| 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 Pragya Varshney |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Materia Medica State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8171288283 |
| Fax |
|
| Email |
garimavarshney23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dileep Kumar Sonkar |
| Designation |
Professor |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Physiology and Biochemistry State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7398204457 |
| Fax |
|
| Email |
drdksonkar86992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Varshney |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8171288283 |
| Fax |
|
| Email |
garimavarshney23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department of State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Pragya Varshney |
| Address |
Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital 1-Viraj Khand Gomti Nagar Lucknow Uttar Pradesh -226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pragya Varshney |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD-6 Department of Homoeopathic Materia Medica State National Homoeopathic Medical College and Hospital Lucknow
Lucknow
UTTAR PRADESH |
8171288283
garimavarshney23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic MedicalCollege and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TO EVALUATE THE EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF UTERINE Fibroid A RANDOMIZED CONTROLLED TRIAL |
Randomization: Patients who fulfill the specific eligibility criteria(inclusion/exclusion criteria) are included in study. 60 Patients will be categorized into two groups of 30 patients each selected as per
randomization. Patients will be randomly divided into two groups A & B as per the computer generated
block randomization chart. - Experimental arm (Group A) – Homeopathic individualized
medicine and Comparator arm
(Group B)– fraxinus americana. Group A patients are advised to take medicine selected as per individualization on the basis of homoeopathic case taking . Potency
and repetition of the dose will be done as per the requirement of the case.
In both the groups unmedicated globules i.e placebo will be given to the patients thrice a
day till final assessment of the case. Follow –ups: Patients will be called for follow-ups
every 15 days or as per the need and the necessity of the case but the final assessment of
the case will be done after 3 months from the baseline. Data obtained from observation after complete study will be statistically analyzed and
interpreted for drawing the appropriate statistical inferences. Outcome will be measured by the primary measure which will be USG.
|
| Comparator Agent |
TO EVALUATE THE EFFICACY OFa
FRAXINUS AMERICANA IN THE MANAGEMENT OF UTERINE FIBROIDA RANDOMIZED CONTROLLED TRIAL |
In a sample size of 60 patients after randomisation Group B will be provided Fraxinus Americana mother tincture 10 Drops thrice a day. Group A will be provided individualized homoeopathic medicine. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Well diagnosed case of uterine fibroid on basis of clinical sign and symptoms along with USG
2. Female patient with age group 20-50 yrs of age
3. Patients providing written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe anemia.hemoglobin levels greater than or equal to 7 g/dl.
2. Abnormal unexplained vaginal bleeding
3.Malignancy of genitourinary tract or history of any malignancy
4.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic
illness or life- threatening infections affecting quality of life or any vital organ failure.
5.Pregnancy and lactation
6.Myoma is more than 12 wks.
7.Substance abuse or dependence
8.Self-reported immune-compromised state
9.Patients who are already enrolled in some other study.
10.Patients unwilling for inclusion in the study and those who are not able to come for
follow-up.
11.Pedunculated fibroid less than 5cm in diameter
12.Very large, Calcified and multiple fibroids filling the Uterine cavity are excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the difference between the effectiveness of individualized homoeopathic medicine and fraxinus Americana in the management of uterine fibroid assessed by the ultrasound. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the symptoms of uterine fibroid & quality of life affected by uterine fibroid by using UFS-QOL questionnaire. |
4 weeks |
|
|
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)
|
21/02/2026 |
| 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
|
Uterine Fibroid is the commonest benign tumor of the uterus and also the commonest benign solid tumor in
females. Histologically, this tumor is composed of smooth muscle and fibrous connective tissue. It has been estimated that at least 20 percent of women at the age of 30 have got fibroid in their
wombs. Fortunately, most of them (50%) remain asymptomatic. They are the leading cause of hysterectomy and a major reason for hospital admissions related to
gynaecological conditions. The conventional treatments for fibroids include GnRH analogues, myomectomy, etc., and the
failure of these procedures complicate infertility further. Homoeopathy provides an effective treatment in cases of Uterine fibroid. This study focuses on to find out the difference between the effectiveness of individualized homoeopathic medicine and fraxinus americana in the management of uterine fibroid assessed by USG and severity of disease assessed by UFS-QOL questionnaire. |