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CTRI Number  CTRI/2025/02/080927 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Treatment of Menorrhagia 
Scientific Title of Study   A Clinical Study on Menorrhagia in Reproductive Age Group with its Homoeopathic Approach 
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 Rita Kumari 
Designation  PGT Department of Practice of Medicine 
Affiliation  R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur Bihar 
Address  Dept. of Practice of Medicine Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Ramdayalu Muzaffarpur Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  9155308843  
Fax    
Email  ritakumariaiapget2023@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rita Kumari 
Designation  PGT Department of Practice of Medicine 
Affiliation  R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur Bihar 
Address  Dept. of Practice of Medicine Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Ramdayalu Muzaffarpur Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  9155308843  
Fax    
Email  ritakumariaiapget2023@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Haresh Kumar Maharaj 
Designation  Associate Professor Department of Practice of Medicine 
Affiliation  R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur Bihar 
Address  Dept. of Practice of MEDICINE Academic Block R.B.T.S Govt. Homoeopathic Medical College and Hospital Ramdayalu Muzaffarpur Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  7903899078  
Fax    
Email  drhareshkumarmaharaj@gmail.com  
 
Source of Monetary or Material Support  
R.B.T.S Govt. Homoeopathic Medical College and Hospital Muzaffarpur Bihar 842002 
 
Primary Sponsor  
Name  R.B.T.S Govt. Homoeopathic Medical College and Hospital  
Address  Ramdayalu Muzaffarpur Bihar India 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 RITA KUMARI  R.B.T.S Govt. Homoeopathic Medical College and Hospital   OPD- 1,3,6 in Hospital Building Muzaffarpur BIHAR HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
Muzaffarpur
BIHAR 		 9155308843

ritakumariaiapget2023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE RBTS GOVT HOMOEOPATHIC MEDICAL COLLEGE AND HOPSITAL MUZAFFARPUR BIHAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDIVIDUALIZED HOMOEOPATHIC MEDICINE  SELECTED MEDICINE WILL BE GIVEN IN 30C 200C AND 1M POTENCY ORALLY AND FOLLOW UP SHOULD BE DONE AT 15 DAYS INTERVAL FOR ABOUT 1 TO 3 MONTHS 
Comparator Agent  NOT APPLICABLE  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  patients of age 18 years to 45 years of reproductive age group. Heavy menstrual bleeding for three months or longer. Patients willing to give consent to participate in the study. Hemoglobin more than 7mg/dl  
 
ExclusionCriteria 
Details  Patients with any gross pathology. Patients with the history of any chronic disease or comorbidity.
Patients who will not agree to participate in study. Hemoglobin less than 7 mg/dl. Pregnant and lactating women. Patients who had taken OCP pills for last 6 weeks. Patient taking any other treatment for menorrhagia from other system of medicine.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The response of the patient will be assessed by a scoring system at base line after a prescribed homoeopathic medicine on the basis of individualisation and acts curatively in case of menorrhagia with no side effects
 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
The response of the patient will be assessed through presence of symptoms, clinical observation and quality of life of patient at base line
 		 3 months 
 
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   Phase 4 
Date of First Enrollment (India)   25/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/02/2025 
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 Yet Recruiting 
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  
Menorrhagia is classified as abnormal uterine bleeding, characterized by regular menstrual cycles with excessive blood flow (greater than 80 ml) or prolonged duration (over 7 days) or both. Certain regions, such as Bihar, experience even higher rates of occurrence. This condition not only affects the quality of life but also poses significant physical and emotional health risks to women. At the RBTS Government Homoeopathic Medical College & Hospital OPD, a large number of patients present regularly with menorrhagia, seeking alternative treatments. Given the growing interest in homeopathic approaches to managing gynecological conditions, a study on menorrhagia with a focus on homeopathic treatment holds great promise. RBTS Government Homoeopathic Medical College & Hospital, with its large patient base and well-equipped facilities, provides an ideal platform for conducting such research. This study will explore the effectiveness of homeopathic remedies in managing menorrhagia, contributing valuable insights into alternative therapeutic approaches for this widespread condition.
 
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