| CTRI Number |
CTRI/2021/12/038645 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of heavy menstrual bleeding |
|
Scientific Title of Study
|
A double blind, randomized, placebo-controlled pilot trial of individualized homeopathic medicines in heavy menstrual bleeding |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1272-2149 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khusbhu Pandey |
| Designation |
House Staff |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Obstetrics and Gynecology, Room no. 4, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8777318316 |
| Fax |
|
| Email |
khusi4n@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suhisna Das |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Organon of Medicine & Homoeopathic Philosophy, Room no. 4 and 10; 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8670602660 |
| Fax |
|
| Email |
suhisna.das@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangita Saha |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Organon of Medicine & Homoeopathic Philosophy, OPD room no. 4 and 10, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8017360163 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, 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 |
| Khushbu Pandey |
D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal |
Dept. of Obstetrics & Gynecology, OPD room no. 4; 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
8777318316
khusi4n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N92||Excessive, frequent and irregularmenstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking placebo |
Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. All the enrolled patients will receive advices on general management in terms of iron, protein and fiber rich diet. Route of administration: Per oral. Duration of therapy: 3 months. |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering individualized homeopathic medicines in centesimal potencies. Each dose will consist of 4 globules (no. 40) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. All the enrolled patients will receive advices on general management in terms of iron, protein and fiber rich diet. Route of administration: Per oral. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Heavy menstrual bleeding (HMB) as substantiated with a Pictorial blood assessment chart (PBAC) score of 100-185
2. Age: 18-45 years
3. Patients taking oral contraceptive pills will be considered for the study after giving a wash-out period of 1 month.
4. Patients giving written consent to participate in the study.
5. Literate patients, who can read and write in Bengali and/or English |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from carcinoma of cervix, chronic tubo-ovarian mass, endometrial carcinoma.
2. Vulnerable population – unconscious, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent.
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
4. Blood haemoglobin level less than 7g/dl.
5. Patient under tobacco chewing and / or smoking, alcoholism and / or any other form(s) of substance abuse and /or dependence.
6. Self-reported immune-compromised state.
7. Undergoing homeopathic treatment for any chronic disease within last 6 months. |
|
|
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 assessment chart (PBAC) score |
At baseline, and after each menstrual cycle up to 3 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menorrhagia multi-attribute quality-of-life scale (MMAS) score |
At baseline, and after each menstrual cycle up to 3 cycles |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
20/12/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 [dndeofficial@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Heavy menstrual bleeding (HMB)
is a common gynecological that adversely affects quality of life and work
productivity. Approximately 10-35%of women report heavy menstrual periods
at some stage during their reproductive years, with 5% consulting a medical practitioner
for investigation of HMB. In research, HMB is defined as a measured menstrual
blood loss of more than 80mL per cycle, but studies have repeatedly that at
least 40% of women seeking medical attention for heavy periods lose less than
this volume. Homeopathy as a therapeutic system may offer significant benefit
to patients suffering from HMB; however, the research evidence remains
compromised. In this double-blind, randomized, placebo-controlled pilot trial
of individualized homeopathic medicines in treatment of HMB at D N De
Homoeopathic Medical College & Hospital, 60 females will be randomized to
receive either homeopathic medicines or identical-looking placebo for a period
of 3 months. PBAC and MMAS scores will be assessed at baseline and at the end
of each menstrual cycle up to 3 cycles as the primary and secondary outcome
measures respectively. Comparative analysis will be carried out after 3 months
of intervention. Results will be published in scientific journals. |