| CTRI Number |
CTRI/2024/07/071486 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Iron deficiency anaemia classified and Managed with Homoeopathy |
|
Scientific Title of Study
|
A Clinical study in the Management of Iron deficiency
Anaemia using Hahnemann’s classification of disease and
Constitution
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdul Gaffor A |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy White Memorial Homoeo Medical College And Hospital Atttoor Veyanoor Post Kanniyakumari Tamil Nadu 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9655825235 |
| Fax |
282282 |
| Email |
agaffor40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu P |
| Designation |
Professor and HOD |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy White Memorial Homoeo Medical College And Hospital Atttoor Veyanoor Post Kanniyakumari Tamil Nadu 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9495704030 |
| Fax |
282282 |
| Email |
indusujan9495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Gaffor A |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy White Memorial Homoeo Medical College And Hospital Atttoor Veyanoor Post Kanniyakumari Tamil Nadu 629177
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9655825235 |
| Fax |
|
| Email |
agaffor40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Organon of Medicine and Homoeopathy Philosophy,
White Memorial Homoeo Medical College and Hospital,
Attoor, Kanniyakumari
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ORGANON OF ORGANON OF MEDICINE AND HOMOEOPATHY PHILOSOPHY |
| Address |
Department Of Organon Of Medicine And Homoeopathic Philosophy White Memorial Homoeo Medical College And Hospital Atttoor Veyanoor Post Kanniyakumari Tamil Nadu 629177 |
| 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 Abdul Gaffor A |
White Memorial Homoeo Medical College And Hospital |
Department Of Organon Of Medicine And Homoeopathic Philosophy White Memorial Homoeo Medical College And Hospital Atttoor Veyanoor Post Kanniyakumari Tamil Nadu 629177
Kanniyakumari
TAMIL NADU |
9655825235
282282
agaffor40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee White Memorial Homoeo Medical College and Hospital |
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 |
Homoeopathic Constitutional Medicine |
Each Case Will be reviewed at 1 month interval and it will be followed up for a period of 12 months |
| Intervention |
Homoeopathic Constitutional Medicine |
Potency selection is based on susceptibility of the participant, Dose is minimum dose, Routes of Administration is oral for a period of 1 month until next follow up |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Mild and moderate anemia will be included by assessing their hemoglobin levels,
mild anemia 11.0-11.9 g/dl, moderate anemia 9.0-10.9g/dL respectively |
|
| ExclusionCriteria |
| Details |
Patients with severe complications of anemia, Patients who had history of any bleeding disorder, Patients associated with any other systemic disorder, Patients who are in need for blood transfusion, Patients suffering from other disease such as SLE Renal failure Diabetes mellitus secondary hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The changes in clinical signs and symptoms
The changes in haemoglobin level
The changes in serum Ferritin level |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After completion of study the changes in clinical signs and symptoms
The changes in haemoglobin level
The changes in serum Ferritin level will be assessed |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/08/2024 |
| 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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [agaffor40@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Minimum of 30 cases are selected for the study Hemoglobin level is used as the tool for inclusion Change in clinical signs and symptoms and Haemoglobin level Serum ferritin levels will be checked before and after the study The constitutional medicine will be prescribed based on the Homoeopathic principles Follow-up treatment will be done at regular intervals (each interval not exceeding a month) or as per the need of the case, for a minimum period of one year and the progress of the cases will be subjected to statistical analysis and presented |