| 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
|
|
|
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
|
|
|
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
|
|
|
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. |