| CTRI Number |
CTRI/2025/03/082006 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of trinitrotoluenum 200c in comparison with individualised homoeopathic medicines in anaemia and in vitro antioxidant assay |
|
Scientific Title of Study
|
Prospective randomised clinical trial to evaluate the effectiveness of trinitrotoluenum 200c in comparison with individualised homoeopathic medicines in anaemia and in vitro antioxidant assay |
| 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 Alin Sara Alex |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9495931613 |
| Fax |
|
| Email |
ponnupallickal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alin Sara Alex |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18
WEST BENGAL
700106
India |
| Phone |
9495931613 |
| Fax |
|
| Email |
ponnupallickal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumaravel V |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9748163274 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Dr Alin Sara Alex
NATIONAL INSTITUTE OF HOMOEOPATHY
BLOCK -GE, SECTOR -III, SALT LAKE, KOLKATA - 700106 |
|
|
Primary Sponsor
|
| Name |
Self Dr Alin Sara Alex |
| Address |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18 |
| Type of Sponsor |
Other [Self] |
|
|
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 Alin Sara Alex |
National Institute of Homoeopathy |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata 700106 West Bengal Department of Homoeopathic Materia Medica OPD Room no 18
Kolkata
WEST BENGAL |
9495931613
ponnupallickal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
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 |
| Comparator Agent |
Individualised homoeopathic medicine |
Individualised homoeopathic medicine in control group.
Detailed and thorough case taking will be done.
Repetition of the doses and change of potency will be done as per the case in hand following the directions laid down by Dr Samuel Hahnemann. |
| Intervention |
Trinitrotoluenum 200c |
Trinitrotoluenum 200c in intervention group.
Detailed and thorough case taking will be done.
Repetition of the doses and change of potency will be done as per the case in hand following the directions laid down by Dr Samuel Hahnemann. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age groups 18-60 of both sex and religion
Persons with more than 7 out of 14 clinical signs and symptoms of anaemia
Cases with haemoglobin concentration less than 12g per dl in males and less than 11.5g per dl in females
Patients willing to give written consent for participating in the study and complete follow up during study
Patients who are able to read Bengali or English or Hindi |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 60
Cases with haemoglobin concentration less than 7g per dl
Cases with serious illness like chronic kidney disease malignancy heart diseases
Pregnant and lactating mothers
Immunocompromised patient
Patient suffering from any severe psychiatric illness
Patient not willing to give written consent
Patients not willing to undergo any investigation if needed |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The response of the patients will be observed and changes in the haemoglobin level before and after the intervention will be assessed |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of antioxidant properties of Trinitrotoluenum by antioxidant assay |
3 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
18/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 defined as a condition in which there is quantitative or qualitative or both deficiency of red blood cell or haemoglobin in circulating blood. WHO estimates worldwide that 40% of children aged 6 to 59 months 37% of pregnant women and 30%of women aged 15 to 49 years are affected by anaemia. Research question is trinitrotoluenum 200c effective in the treatment of anaemia in comparison with individualised homoeopathic medicines and has antioxidant property. Null hypothesis is there is no significant change in the levels of haemoglobin treated with Trinitrotoluenum 200c in comparison with individualised homoeopathic medicine for 6 months.Alternative hypothesis there is significant change in the levels of haemoglobin treated with Trinitrotluenum 200c in comparison with individualised homoeopathic medicine for 6 months. The aim of this study is to determine the effectiveness of Trinitrotoluenum 200c in comparison with individualised homoeopathic medicine in the treatment of anaemia and to assess the antioxidant properties.The primary objective is to compare the pre and post treatment effect of Trinitrotoluenum 200c and individualised homoeopathic medicines in patients suffering from anaemia through randomised clinical trial.Secondary objective is identification of antioxidant properties of trinitrotoluenum 200c by antioxidant assay.It is a prospective randomised clinical trial conducted at the OPD setting of National Institute of Homoeopathy Kolkata where each case will be taken in detail appropriate consent taken and patient will be enrolled. Adequate dietary modifications will be advised for good results.Appropriate statistical tools will be used and data analysed at the end of the study. |