| CTRI Number |
CTRI/2024/03/063537 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of individualised homoeopathic medicines in managing HbA1C levels in patients suffering from Type2 Diabetes Mellitus using Synthesis Repertory. |
|
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicines in managing HbA1C levels in patients suffering from Type2 Diabetes Mellitus using Synthesis Repertory by Frederik Schroyens: An open label 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 |
SHANA ANSARI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
DEPARTMENT OF CASE TAKING AND REPERTORY, NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK- GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA.
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7376748268 |
| Fax |
|
| Email |
ansari.shana2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BINOD KUMAR BHAGAT |
| Designation |
PROFESSOR Department of Case Taking and Repertory |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
DEPARTMENT OF CASE TAKING AND REPERTORY, NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK- GE, SECTOR-III, BIDHANNAGAR,SALT LAKE, KOLKATA.
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BINOD KUMAR BHAGAT |
| Designation |
PROFESSOR Department of Case Taking and Repertory |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
DEPARTMENT OF CASE TAKING AND REPERTORY, NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK- GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA.
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK- GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA, WEST BENGAL
PIN- 700106 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
NATIONAL INSTITUTE OF HOMOEOPATHY, BLOCK- GE, SECTOR-III, BIDHANNAGAR, SALT LAKE, KOLKATA, WEST BENGAL, PIN 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 |
| Dr SHANA ANSARI |
NATIONAL INSTITUTE OF HOMOEOPATHY |
DEPARTMENT OF CASE TAKING AND REPERTORY,
BLOCK- GE,
SECTOR-III, BIDHANNAGAR,SALT LAKE, KOLKATA.
North Twentyfour Parganas
WEST BENGAL |
7376748268
ansari.shana2@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: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALISED HOMOEOPATHIC MEDECINES SELECTED USING SYNTHESIS REPERTORY |
Indicated individualised homoeopathic medicine will be prescribed after proper case taking and then repertorisation using synthesis repertory. Fifty-millesimal potency and centesimal potency will be prescribed to the patients. Dose and frequency of the medicine prescribed will be selected as per the susceptibility of the case. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients diagnosed with Type2 Diabetes Mellitus and not taking any allopathic or other conventional treatment will be considered for the study.
2)Those who are taking hypoglycemic medication will be requested to discontinue the course for a period not exceeding 7days at whatsoever time and those agreeing to it will be considered for this study.
3)Patients whose HbA1c level is above 6.5mg/dl.
4)Adults of both gender and belonging to age group 18yrs-65yrs.
5)Subjects of all socio-economic status and all religions.
6)Patients giving written consent to participate in the study and agree to comply with protocol.
7)Illiterate patients will also be included after providing verbal explanation in vernacular language about the study and getting verbal response and written consent if they agree to participate in study.
8)Subjects who agree to undergo laboratory investigation whenever required.
|
|
| ExclusionCriteria |
| Details |
1)Patients with insulin dependence or on any drug dependence for any chronic illness which cannot be discontinued.
2)Patients of unstable mental or psychiatric illness or suffering from any other life-threatening illness/organ failure and immune- compromised state etc.
3)Patients who are pregnant or lactating mothers.
4)Patients not willing to participate in the study.
5)Substance abuse and/or dependence.
6)Cases already undergoing homoeopathic treatment elsewhere for any chronic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c levels of each individual patient will be recorded at the time of inclusion into the study (baseline) and after 6 months of treatment, then both the data will be compared. |
HbA1c levels of each individual patient will be recorded at the time of inclusion into the study (baseline) and after 6 months of treatment, then both the data will be compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
11/03/2024 |
| 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
|
Type 2 Diabetes Mellitus is a complex heterogenous metabolic disorder characterised by chronic elevation of plasma glucose levels. The most important pathophysiologic features are decreased insulin sensitivity (insulin resistance) and impaired insulin secretion. It is a major public health issue and an important contributor to morbidity and mortality, not only in India but all around the world. It is most common in people over 30s but is also seen increasingly in adolescents and young adults due to rising levels of obesity, physical inactivity and energy-dense diets. Characteristic laboratory finding is HbA1C levels which is diagnostic also. Type2 Diabetes Mellitus can be successfully managed using homoeopathic medicines, by bringing changes in HbA1C levels to normal range. An open label, prospective clinical study to know the effectiveness of individualised homoeopathic medicines in managing HbA1C levels in people suffering from Type 2 Diabetes Mellitus will take place at National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal. Study has a target to achieve sample of 40 patients. Outcome assessment will be done by seeing changes in HbA1C levels at baseline and after 6 months. The results will be analysed as per appropriate statistical methods and inference will be done thereafter. |