CTRI Number |
CTRI/2020/10/028624 [Registered on: 26/10/2020] Trial Registered Prospectively |
Last Modified On: |
16/07/2023 |
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 anaemia due to lo level of iron in body |
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled, pilot trial of individualized homoeopathic medicines in iron deficiency anaemia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1259-4517 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saleema Naaz Tabassum |
Designation |
Postgraduate Trainee |
Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Address |
Department of Homoeopathic Materia Medica; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road), Doomurjala
Haora WEST BENGAL 711104 India |
Phone |
9007743845 |
Fax |
|
Email |
farheenomar41@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Madhabananda Saha |
Designation |
Principal |
Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Address |
Department of Homoeopathic Materia Medica; OPD no. 9; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road); Doomurjala
Haora WEST BENGAL 711104 India |
Phone |
9434230785 |
Fax |
|
Email |
principalmbhmch@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof Dr Shubhamoy Ghosh |
Designation |
Professor and Head |
Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Address |
Department of Pathology and Microbiology; OPD no. 2; Dr. Bholanath Chakraborty Sarani (Drainage Canal Road); Doomurjala
Haora WEST BENGAL 711104 India |
Phone |
9831034229 |
Fax |
|
Email |
shubhamoy67@gmail.com |
|
Source of Monetary or Material Support
|
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. Bholanath Chakraborty Sarani (Drainage Canal Road); Doomurjala, Howrah 711104 |
|
Primary Sponsor
|
Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Address |
Dr. Bholanath Chakraborty Sarani, Drainage Canal Road; Doomurjala, Howrah 711104 |
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 |
Saleema Naaz Tabassum |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Homoeopathic Materia Medica; OPD room no. 9; Dr. Bholanath Chakraborty Sarani, Drainage Canal Road; Doomurjala, Howrah 711104 Haora WEST BENGAL |
9007743845
farheenomar41@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: D509||Iron deficiency anemia, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) 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 medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Each patients will receive standard dietary counselling. Iron rich foods such as dark green leafy vegetables, lean meat, fish, eggs, pulses and beans, nuts and seeds will be advised to the patients. Tea, coffee, antacids etc. which make iron absorption difficult will be asked to avoid. Food and drink containing vitamin C will be encouraged. Duration of therapy: 3 months. |
Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 30) 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. Each patient will receive standard dietary counselling. Iron rich foods such as dark green leafy vegetables, lean meat, fish, eggs, pulses and beans, nuts and seeds will be advised to the patients. Tea, coffee, antacids etc. which make iron absorption difficult will be asked to avoid. Food and drink containing vitamin C will be encouraged. Duration of therapy: 3 months. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients suffering from iron deficiency anaemia, Hb% 7-12 gm/dl and serum ferritin level <30 ng/mL, ICD-10: D50.9
2. Both male and female patients
3. Age 18-65 years
4. Patients taking iron supplements will be advised to stop the supplements for 14 days, followed by re-assessment of blood markers in the next enrolment
5. Literate patients; ability to read and write in Bengali and/or English
6. Patients providing written informed consent |
|
ExclusionCriteria |
Details |
1. Patients with haemoglobin less than 7 gm/dl (severe anaemia)
2. Patients who are too sick for consultation
3. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life- threatening infections affecting quality of life or any vital organ failure
4. Pregnancy, puerperium and lactation
5. Substance abuse and/or dependence
6. Self-reported immune-compromised state
7. Undergoing homoeopathic treatment for any chronic disease within last 6 months |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Blood Hb% and serum ferritin level |
At baseline and after 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Fatigue severity scale (FSS) scores |
At baseline and after 3 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
26/10/2020 |
Date of Study Completion (India) |
30/03/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet; to be published later |
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 [farheenomar41@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
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
Modification(s)
|
Iron deficiency anemia (IDA) is a problem of high magnitude in developing countries, especially among women and children. Global prevalence is estimated at 24.8% of the population. No trial in homeopathy has yet been up taken to explore the effects of individualized homeopathic medicines (IHMs) in IDA. The objective of this trial was to explore the efficacy of IHMs in the treatment of IDA. A double-blind, randomized, placebo-controlled trial was conducted at the Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India. Sixty participants with IDA were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Primary outcome measures were blood hemoglobin percentage and serum ferritin level; secondary outcome measure was the fatigue severity scale (FSS) questionnaire scores; all measured at baseline and after 3 months. Group differences and effect sizes (Cohen’s d) were calculated on the intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention, and attrition rates were 47.2%, 95%, and 5% respectively. Group differences in serum ferritin level favored IHMs against placebo (P = 0.019), but differences in blood hemoglobin percentage (P = 0.201) and FSS questionnaire scores (P = 0.301) were non-significant. Natrum muriaticum and Sulphur were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harm or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IDA. Independent replications are warranted to substantiate the findings. |