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CTRI Number  CTRI/2023/05/052233 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Treatment Of Uterine Fibroid Using Epihysterinum 
Scientific Title of Study   A Clinical Trial On The Efficacy Of Epihysterinum In The Treatment Of Uterine Fibroid 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR KAJAL 
Designation  Assistant proffessor Department of Practice of Medicine 
Affiliation  RBTS Govt Hom Medical College and Hospital 
Address  Department of Practice of Medicine RBTS Govt Hom Medical College and Hospital RAMDAYALU NAGAR PO RAMNA

Muzaffarpur
BIHAR
842002
India 
Phone  7979096206  
Fax    
Email  kajalrbts04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KESHAV GUPTA 
Designation  PGT Department of Practice of Medicine 
Affiliation  RBTS Govt Hom Medical College and Hospital 
Address  Department of Practice of Medicine RBTS Govt Hom Medical College and Hospital RAMDAYALU NAGAR PO RAMNA

Muzaffarpur
BIHAR
842002
India 
Phone  8984681057  
Fax    
Email  drgkeshav.257@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR NIRBHAY KUMAR 
Designation  PGT Department of Materia Medica 
Affiliation  RBTS Govt Hom Medical College and Hospital 
Address  Department of Materia Medica RBTS Govt Hom Medical College and Hospital RAMDAYALU NAGAR PO RAMNA

Muzaffarpur
BIHAR
842002
India 
Phone  8240395208  
Fax    
Email  nirbhay15521@gmail.com  
 
Source of Monetary or Material Support  
RBTS GOVT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Ramdayalu Nagar PO Ramna Muzaffarpur Bihar- 842002 
 
Primary Sponsor  
Name  RBTS GOVT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  RAMDAYALU NAGAR PO RAMNA MUZAFFARPUR BIHAR 842002 
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 KAJAL  OPD 3 and IPD Dept of Obs and Gyn RBTS GOVT HOM MED COLLEGE AND HOSPITAL  RAMDAYALU NAGAR PO RAMNA MUZAFFARPUR BIHAR
Muzaffarpur
BIHAR 		 7979096206

kajalrbts04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RBTS GOVT HOM MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR BIHAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EPIHYSTERINUM 30/200/1M  Medicine will be given in 1 dose by oral route based on the follow up done at 15 days interval over a duration till the patient is not cured within 1 year of research maximum  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Self reported and prediagnosed cases of Uterine Fibroids.
Patients with symptomatology of Uterine Fibroids.
Cases confirmed by USG or Laproscopy.
Uterine fibroid of size less than 12 weeks
 
 
ExclusionCriteria 
Details  Patients or its guardian unwilling to take part or not giving consent to join the study.
Diagnosed cases of systemic diseases psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure.
Substance abuse and or dependence.
Self reported immunecompromised state.
Uterine Fibroid of size more than 12 weeks
Persistent uterine bleeding despite medical therapy
Excessive pain or pressure symptoms
Recurrent pregnancy loss due to fibroid/or Rapidly growing myoma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in their symptomatology.
Improvement in Aberdeen Menorrhagia Severity Scale(AMSS) score.
 		 0-3 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
uterine fibroids Symptom and Quality of life UFSQOL  0-6 MONTHS 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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   Phase 4 
Date of First Enrollment (India)   02/05/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Uterine fibroids are noncancerous growths of the uterus that often appear during childbearing years. Also called leiomyomas or myomas[1]. Symptoms of fibroid uterus- asymptomatic in majority (75%), menstrual abnormality: menorrhagia, metrorrhagia dysmenorrhea, dyspareunia, subfertility, pressure symptoms, recurrent pregnancy loss (miscarriage, preterm labor), lower abdominal or pelvic pain, abdominal enlargement. The increasing prevalence and risk of progression of the disease has increased the cases of secondary infertility, this demands therapeutic attention. With this intention, we plan to test the effectiveness of Epihysterinum in uterine fibroid.


 
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