| CTRI Number |
CTRI/2025/02/081150 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine in case of Anaemia |
|
Scientific Title of Study
|
Role of Homoeopathic Medicine in Anaemia using Boenninghausen Characteristics and Repertory by C M Boger- A Single Arm Prospective Clinical Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mem Perme |
| Designation |
PGT Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No.10, Department of Repertory, National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9402066837 |
| Fax |
|
| Email |
kamem25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No.10, Department of Repertory, National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432497634 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No.10, Department of Repertory, National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9432497634 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata West Bengal India, 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata West Bengal India 700106 |
| 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 |
| Mem Perme |
National Institute Of Homoeopathy |
OPD Room No.10,
Department of Repertory, National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata 700106
North Twentyfour Parganas
WEST BENGAL |
09402066837
kamem25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D649||Anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
1.Indicated individualized homoeopathic medicine will be prescribed, after a detailed or thorough case-taking in accordance with the directions laid down in the Organon of Medicine.
2.Repertorization of the cases will be done by considering the Totality of Symptoms using Boenninghausen Characteristics and Repertory by C M Boger.
3.Selection of Potency will be made depending on the individual case.
4.Repetition of doses and change of potency will be done according to the individualization of the case and following homoeopathic philosophy.
5.Hb % and Fatigue Severity Scale will be measured at baseline and after 6 - 7 months after treatment with the medicine.
6.Follow up will be done monthly till 6 months from the baseline.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from anaemia, with hemoglobin level between 7g/dl -12g/dl
Patients of all socio-economic status and religions.
Patients willing to give consent to participating in the study.
|
|
| ExclusionCriteria |
| Details |
Patients having Hemoglobin level less than 7gm/dl
Patients with early functional changes like any cause of trauma or injury due to which blood loss or low Hb% occur.
Patients with other diagnosed cases of anaemia viz. sickle cell anaemia, thalassemia, aplastic anaemia, hemolytic anaemia etc.
Patients suffering from chronic kidney disease, malignancy and heart disease etc.
patients who are on substance abuse or dependence.
Patients already taking homeopathic medicine for any chronic diseases.
Pregnant and lactating women.
Patients suffering from unstable mental or psychiatric illness or other uncontrolled or life-threatening illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hb% |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue Severity Scale |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/02/2025 |
| 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) |
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 - NO
|
|
Brief Summary
|
Anaemia is condition in which the number of red blood cell or the hemoglobin concentration within them is lower than the normal which cause easily Fatigue, shortness of breath, palpitation, vertigo, headache etc. if not treated can cause serious issue on health and development. 1. Sample will be selected following preliminary and detailed screening using selected criteria. 2. Inclusion and exclusion criteria will be strictly follow. 3. After consideration of drops-out cases a minimum 40 cases will be enrolled for the study. 4. Case-taking will be done as per the strict homoeopathic principle. 5. Baseline scoring will be taken using Hb% and FSS. 6. Analysis and evaluation of each cases will be done. 7. Miasmatic analysis will be done. 8. Repertorization will be done by using Boenninghausen Characteristic and Repertory. 9. Final selection of the remedy will be done after consultation with Materia Medica. 10. Potency, Doses and Repetition of the indicated remedies will be guided strictly as per homoeopathic principle. 11. General( non-medical) management including appropriate diet and regimen will be advised. 12. Subsequent prescription (follow-up) will be generated according to relevant homoeopathic principle and will be recorded in the follow-up sheet 13. The baseline data will be compared with the data obtained after 6th months. 14. the score obtained will be compared and the result will be analyzed as per statistical methods and interference will be done thereafter.
|