| CTRI Number |
CTRI/2024/12/077758 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of homoeopathic medicines in the cases of metabolic syndrome among adults |
|
Scientific Title of Study
|
Effect of individualized homoeopathic medicines in the cases of metabolic syndrome among adult population- a prospective pre-post clinical study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farhat Jabeen |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicines
Basement floor
Room no B16 and B17
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
6291694622 |
| Fax |
|
| Email |
drfarhatjabeen83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Goswami |
| Designation |
Guide & Associate Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicines
Basement floor
Room no B16 and B17
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9899602004 |
| Fax |
|
| Email |
vijaya84goswami@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD & PG incharge |
| Affiliation |
Bakson Homoeopathic medical college and hospital |
| Address |
Department of Homoeopathic Materia Medica
Second Floor
Room no S1
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college and hospital
B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Bakson homoeopathic medical college and hospital |
| Address |
Principal office
Ground floor
Room no G 22
Bakson homoeopathic medical college and hospital
B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farhat Jabeen |
Bakson homoeopathic medical college and hospital |
Out Patient Department(OPD)
Ground floor
Room no 1
Bakson homoeopathic medical college and hospital
B36 Knowledge Park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
6291694622
drfarhatjabeen83@gmail.com |
| Dr Farhat Jabeen |
Dr D P Rastogi Central Research Institute Of Homoeopathy |
Out Patient Department(OPD)
Ground floor A1/1
Room no 110
Sector 24 Noida
201301
Gautam Buddha Nagar
UTTAR PRADESH |
6291694622
drfarhatjabeen83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E88||Other and unspecified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
Oral Route of Administration
centesimal scale
pill form size 30 First dose at the time of case taking
subsequent doses according to follow ups
In L M Potency oral route of administration liquid form (water as a vehicle) one poopy sized globule of desired potency will be dissolved in 120ml of distilled water, one teaspoon is added in a cup of water is to be considered as
First dose given after case taking repetition is based on susceptibility and follow up of the patient at regular interval. |
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group between 18 to 54 years and all genders
Diagnostic criteria If any 3 conditions of the criteria given below is found in a participant he/she will be included in the study
Triglyceride level more than 150 mg/dl (Mild hypertriglyceridemia 150 to 499 mg/dL)
HDL level low less than 40 mg/dl
Blood pressure more than 130/85 mmHg (stage 1 and stage 2)
Fasting blood glucose level more than 120 to 240 mg/dl
BMI obesity class1 BMI 30 to 34.9 kg/meter square
Participants willing to give consent will be included
|
|
| ExclusionCriteria |
| Details |
Participants with other severe systemic illness requiring emergency care and who are immune compromised
Pregnant and lactating women
Participants who have taken any homoeopathic medicines for last 3 months
Participants with any substance use disorder and severe mental disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes will be observed in MSSS scale.
Changes can be positive or negative or no change. |
15 months
Enrolment-6 months
Follow up- 6 months
Statistical analysis- 3 months
First dose will be given after case taking.
Subsequent doses as per the follow ups.
MSSS scale will be used at baseline at 3 months and at 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/12/2024 |
| 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="3"
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
|
This prospective observational study aims to evaluate the effect of individualized homoeopathic medicines in the centesimal and L M potency in the cases of Metabolic syndrome. Primary outcome is to assess the change in MSSS scale at baseline at 3rd months at the 6th months. The result will be concluded accordingly. study duration is 15 months. sample size will be 47. |