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CTRI Number  CTRI/2025/08/093412 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Homoeopathic Management of uterine bleeding disorders in females 
Scientific Title of Study   A comparative study of Repertorial and Non-Repertorial approach in treating Menorrhagia 
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 LEKSHMI G J 
Designation  POST GRADUATE 
Affiliation  SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL  
Address  ROOM NUMBER:301 SECOND FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI DISTRICT TAMIL NADU 629161

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9497036979  
Fax    
Email  lekshmigjsubramoniam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V SATHISH KUMAR 
Designation  HOD AND PROFESSOR 
Affiliation  SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL  
Address  ROOM NUMBER:301 SECOND FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI DISTRICT TAMIL NADU 629161

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443558483  
Fax    
Email  hodcr@skhmc.org  
 
Details of Contact Person
Public Query
 
Name  Dr V SATHISH KUMAR 
Designation  HOD AND PROFESSOR 
Affiliation  SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL  
Address  ROOM NUMBER:301 SECOND FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI DISTRICT TAMIL NADU 629161

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443558483  
Fax    
Email  hodcr@skhmc.org  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  POST GRADUATE DISSERTATION SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI DISTRICT TAMIL NADU 629161 KANYAKUMARI DISTRICT TAMIL NADU 629161 
Type of Sponsor  Private 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 V SATHISH KUMAR  SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL   ROOM NUMBER 1O3 GROUND FLOOR SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL KULASEKHARAM KANNIYAKUMARI DISTRICT 629161
Kanniyakumari
TAMIL NADU 
09443558483

hodcr@skhmc.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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, (2) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HOMOEOPATHIC MEDICINE THROUGH REPERTORISATION PROCESS, HOMOEOPATHIC MEDICINE THROUGH NON-REPERTORISATION PROCESS  HOMOEOPATHIC MEDICINE WILL BE GIVEN ORALLY A SINGLE DOSE ONCE IN 2 WEEKS 
Intervention  HOMOEOPATHIC MEDICINE THROUGH REPERTORISATION PROCESS,HOMOEOPATHIC MEDICINE THROUGH NON-REPERTORISATION PROCESS  HOMOEOPATHIC MEDICINE WILL BE GIVEN ORALLY A SINGLE DOSE ONCE IN 2 WEEKS 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women diagnosed with menorrhagia excessive menstrual bleeding lasting more than 7 days or
blood loss more than 80mL per cycle
Women of reproductive age 15-55years
Participants with regular or irregular cycles with prolonged or heavy menstrual bleeding
Patients who give consent for participating in this study including follow-ups and adherence to
prescribed homoeopathic treatment only 
 
ExclusionCriteria 
Details  Severe Anemia Hemoglobin level less than 8 g per dL requiring blood transfusion or immediate medicalintervention
Any history of malignancy
Unwillingness to Follow Protocol
Patients under any psychiatric treatment
Lactating women as hormonal changes may influence menstrual patterns
Currently on any treatment particularly hormonal therapy hormonal IUDs oral contraceptives hormone replacement therapy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess the therapeutic outcomes of the repertorial approach in managing menorrhagia through
individualized remedy selection based on totality of symptoms by using Murphy Repertory.
2.To assess the therapeutic outcomes of the non-repertorial approach in managing menorrhagia
through remedy selection based on Allen’s Keynotes and Boericke’s Materia Medica. 
Once in 2 weeks assessment 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the duration of treatment and symptom relief (using PBAC score chart) in both
approaches .
2. To assess the hemoglobin level in menorrhagia cases.
3. To analyse the improvement of quality of life of patient using SF-36 Questionnaire. 
The cases will be followed up every two weeks, or more frequently if the individual’s condition
requires, to monitor changes in PBAC scores, hemoglobin levels (Hb%), SF-36 scores, and overall
symptomatology. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/08/2025 
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 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  

Menorrhagia a common gynecological complaint is characterized by regular cyclic menstrual bleeding that is excessive in volume greater than equal to 80 mL or prolonged less than7 days .It arises from multifactorial causes including structural abnormalities such as fibroids and polyps systemic disorders like coagulation defects and thyroid dysfunction and hormonal imbalances as seen in PCOS and anovulatory cycles. Conventional management including NSAIDs hormonal therapy and surgical interventions often focuses on symptom control may cause adverse effects and is not always individualized .

Homoeopathy offers a safe constitutional and patient centered alternative aimed at addressing underlying causes .This prospective randomized clinical study was conducted over one year on 54 cases of menorrhagia from OPD IPD and peripheral health centers of Sarada Krishna Homoeopathic Medical College & Hospital. Out of 54 cases 27 will be treated using a repertory based approach Murphy repertory while the other 27 will be treated using Nonrepertorial approach Allen’s Keynotes and Boericke’s Materia Medica.

Baseline assessment included Pictorial Blood Assessment Chart PBAC scores hemoglobin levels and SF36 quality of life scores. Detailed case-taking was followed by individualized prescriptions with potency and repetition tailored to patient needs. Follow-ups were scheduled every two weeks or more frequently as required. Outcomes measured included changes in PBAC scores ,hemoglobin levels ,SF36 scores duration of bleeding and improvement in anemia related symptoms .Statistical analysis compared therapeutic effectiveness duration of treatment and quality of life improvements between the two approaches .The study aims to determine the relative efficacy of repertorial versus non repertorial homoeopathic prescribing in reducing menstrual blood loss, improving hemoglobin levels and enhancing quality of life thereby contributing to evidence based strategies for individualized management of menorrhagia.

 
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