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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  
Name  Address 
None  NA 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [farheenomar41@gmail.com].

  6. 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.

  7. 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.

 
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