| CTRI Number |
CTRI/2024/12/078220 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of heavy menstrual bleeding |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of heavy menstrual bleeding of reproductive females: A Double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-0884 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nargis Khatun |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1 and Gyn (room no. 4), 12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9614192289 |
| Fax |
|
| Email |
nargiskhatun4727@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Ganguly |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Ganguly |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick Road Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road Kolkata 700046 |
| Type of Sponsor |
Government 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 Nargis Khatun |
D N De Homoeopathic Medical College and Hospital |
Dept of Organon of Medicine OPD no PG1 and 4 (Gynae and Obs), 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
9614192289
nargiskhatun4727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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: N921||Excessive and frequent menstruation with irregular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This arm will be given a placebo that looks exactly like Verum. 4 cane sugar globules (no. 40) moistened with rectified spirit (90%v/v ethanol) are required for each dosage of placebo, which should be taken orally on an empty stomach and clean tongue; Dosage and repetition will vary based on each cases unique requirements. All medicines will be procured from a Good Manufacturing Practice (GCP) certified firm. Concomitant care measures include enough of green leafy vegetables, grains like wheat, lentils, soy beans, spinach, eggs, and goat or sheep liver, Vitamin C-rich fruits etc. Route of administration: per oral. Duration of follow up: 6 consecutive menstrual cycles.Repackaged in identical glass bottles, the medications and placebos will be labeled with code, name of the medicine, potency, and distributed in accordance with the random number list. Dose: Individualized. Potency: Individualized. Route of administration: per oral. Duration of follow up: 6 consecutive menstrual cycles. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage in centesimal potencies plus concomitant care |
The enrolled patients of HMB will be treated with IHMs. Administering recommended homoeopathic medications at centesimal potencies is the proposed intervention (CH). The prescribed medication will be soaked into 4 cane sugar no. 40 globules (preserved in 90% v/v ethanol) for each dose , to be taken orally, on an empty stomach, with clean tongue; dosage and frequency to be determined by the specific needs of each case.
Within 30 minutes of consuming the globules, patients will be instructed not to handle the globules, nor to eat, drink, smoke, or brush their teeth. Instead of swallowing the globules, they will be asked to suck them. Every time, a single customized medication will be prescribed after taking into account the
entirety of the patients symptoms, the clinical history, the patients constitutional characteristics, any
miasmatic expressions, and, when necessary, repertorization using RADAR/HOMPATH software. This
will be done after consulting the Materia Medica and reaching a consensus among three Homoeopaths. Every drug and other item will be purchased from a company that has earned Good Manufacturing
Practice (GMP) certification. Accordance with the principles of classical homoeopathy, provisions will be maintained to alter the medications or potencies and modify the dosage on subsequent visits as
needed and these occurrences will be compared between groups. Concomitant care measures include enough of green leafy vegetables, grains like wheat, lentils, soy beans, spinach, eggs, and goat or sheep liver, Vitamin C-rich fruits etc. Dose: Individualized. Potency: Individualized. Route of administration: per oral. Duration of follow up: 6 consecutive menstrual cycles. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age- reproductive females between 13 and 40 years.
2.Patients of mild and moderate cases of heavy menstrual bleeding assessed by PBAC score between 100 and 185.
3.Participants who can clearly understand and fill the Pictorial blood loss assessment chart questionnaires. |
|
| ExclusionCriteria |
| Details |
1. Failing to give written, informed consent or assent before participating.
2. Cases of Malignancy (M), Coagulopathy (C), Ovulatory cause (O), Iatrogenic (I), Not otherwise classified (N) as per Figo classification of PALM-COEIN.
3. Hemoglobin less than 7 gm /dl.
4. Suffering from any uncontrolled systemic diseases like diabetes, hypertension, thyroid disorders, etc.
5. Women having leiomyoma size of 5 cm or more.
6. Women who are planning for child within 1 year.
7. Patient undergoing any hormonal replacement therapy, using contraceptive pills, intra uterine devices or history of their use in previous 3 months.
8. Those who are too ill to get consultation.
9. Diagnosed cases of uncontrolled or potentially fatal illnesses impacting quality of life, such as unstable mental or psychiatric illnesses.
10. Lactating mothers and women in puerperal states.
11. AIDS, hepatitis, and other self-reported immune weakened states.
12. Receiving homeopathic treatment within the last 3 months for any chronic illness.
13. Concurrent involvement in any other clinical study.
14. The requirement for further procedures in addition to surgery.
15. Chewing tobacco, smoking, alcoholism, any kind of substance addiction, abuse, and/or dependence (TAPS tool). |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pictorial Blood Loss Assessment Chart (PBAC) |
Baseline, 4 weeks, and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual Bleeding Questionnaires (MBQ) |
Baseline, 4 weeks, & 8 weeks |
| Measure Yourself Medical Outcome Profile v-2 (MYMOP-2) |
Baseline, 4 weeks, & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nargiskhatun4727@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Heavy menstrual bleeding is a common gynecological complaint that is characterised by excessive menstrual blood loss > 80ml which interferes with the women’s physical, emotional, social and psychological quality of life. In 2024 estimated that during the reproductive years, it affects about 1 in 5 women. Heavy menstrual bleeding is the leading cause of iron deficiency anemia. Throughout the reproductive years, 10-35% of women report having profuse bleeding and 5% seek medical attention. Previous studies suggests potential benefits of individualized homoeopathic treatments in managing different gynecological chronic conditions but rigorous evidence supporting its efficacy in HMB is limited. This study aims to evaluate the efficacy and to fill the gap in scientific research on the use of IHMs for heavy menstruation. A double-blind, randomized, placebo-controlled trial will be conducted on 66 reproductive females suffering from heavy menstrual bleeding at the outpatients of D.N. De Homoeopathic Medical College and Hospital. The primary outcome measure is PBAC score; the secondary outcomes are MBQ, and MYMOP-2 questionnaires, all are measured at baseline, and every cycle, up tp 6 consecutive menstrual cycles. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals. |