| CTRI Number |
CTRI/2025/02/080807 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of effect of homoeopathic medicine in case of diabetes mellitus type 2 in reduction of hba1c levels |
|
Scientific Title of Study
|
Evaluation of the effect of Cephalandra indica in centesimal potencies in reducing HbA1c levels in Type II Diabetes mellitus single arm interventional 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 Vaishnabi Rastogi |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
GE Block, Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163218851 |
| Fax |
|
| Email |
vaishnabi94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnabi Rastogi |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
GE Block, Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homeopathic Materia medica OPD Room no 18
WEST BENGAL
700106
India |
| Phone |
9163218851 |
| Fax |
|
| Email |
vaishnabi94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapan Paul |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
GE Block, Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Dr Vaishnabi Rastogi |
| Address |
National Institute of Homoeopathy
GE Block, Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homeopathic Materia medica OPD Room no 18 |
| Type of Sponsor |
Other [Self Dr Vaishnabi Rastogi] |
|
|
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 Vaishnabi Rastogi |
National institue of Homoeopathy |
National Institute of Homoeopathy
GE Block, Saltlake Sector 3 Kolkata 700106 West Bengal Department of Homeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL |
9163218851
vaishnabi94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of 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 |
| Comparator Agent |
nil |
nil |
| Intervention |
Specific homeopathic medicine Cephalandra indica in centesimal potency |
Specific homeopathic medicine Cephalandra indica in centesimal potency monthly after complete follow up and final analysis after 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age from 30 to 60 years
all genders willing to give written consent for participation and able to understand Bengali/ English/ Hindi
HbA1c more than 6.5% less than 8 %
Fbs more than 126 mg/dL less than 250 mg/dL
Ppbs more than 200 mg/dL less than 350 mg/dL
Patients with symptoms of Cephalandra indica |
|
| ExclusionCriteria |
| Details |
Patients aged below 30 and above 60 years
Patients having severe complications like hypoglycaemic coma retinopathy malignancy etc
Immunocompromised patients suffering from HIV TB or psychiatric illness or under any antihypertensive anti diabetic or steroid medication or taking homeopathic medicine for any other systemic disorder in the last 3 months
Patients not willing to give written consent or undergo any investigation as well as pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cephalandra indica causes significant reduction in serum HbA1c levels in patients suffering from Type 2 Diabetes mellitus |
Baseline 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cephalandra indica in centesimal potency causes significant changes in serum FBS, PPBS levels in patients of Diabetes mellitus type 2
Cephalandra indica in centesimal potency causes significant changes in the score of quality of life questionnaire SF36
Causal relationship is established between intervention and outcome through MONARCH |
Baseline 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
23/02/2025 |
| 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 Yet Recruiting |
| 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
|
Research Question is Does Cephalandra indica in centesimal potency have any significant effect in reducing HbA1c levels in patients of Type 2 Diabetes mellitus over 6 months of treatment? Null Hypothesis is There is no significant reduction in HbA1c level in patients of Diabetes mellitus type 2 treated with Cephalandra indica in centesimal potency over 6 months. Alternate hypothesis is There is significant reduction in HbA1c level in patients of Type 2 Diabetes mellitus treated with Cephalandra indica in centesimal potency over 6 months. Aim is to determine the usefulness of Cephalandra indica in centesimal potency in patients suffering from Type 2 Diabetes mellitus where the primary objective is to compare the mean score of HbA1c levels over 6 months of treatment. The secondary objective is to compare the mean score of serum FBS and PPBS level in patients of Type 2 Diabetes mellitus over 6 months of treatment. To compare the mean score of the Quality of life SF36 questionnaire in patients of Type 2 diabetes mellitus over 6 months of treatment and to assess the causal relationship between the given intervention and the clinical outcome through MONARCH at 6th month. It is a single arm interventional study , conducted at the OPD setting of National Institute of Homoeopathy, Kolkata where each case will be taken in detail, appropriate consent taken and then the patient will be enrolled. Adequate lifestyle and dietary modification will be advised for good results. Appropriate statistical tools will be used and data analysed at the end of the study. |