| CTRI Number |
CTRI/2024/12/077870 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Homoeopathy in treatment of Dyslipidemia among adults |
|
Scientific Title of Study
|
Effect of individualized homoeopathic medicines in Dyslipidemia among adults : an exploratory 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 Nitya Pandey |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
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 |
8826140073 |
| Fax |
|
| Email |
nits.pnd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Mathur |
| Designation |
Guide and Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
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 |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Professor and HOD |
| 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 I
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 G22
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
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 Nitya Pandey |
Bakson Homoeopathic Medical College and Hospital |
Outpatient Department(OPD)
Ground floor
Room no 1
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
8826140073
nits.pnd@gmail.com |
| Dr Nitya Pandey |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Out Patient Department (OPD)
Ground Floor A 1/1
Room no 110
Sector 24 Noida
201301
Gautam Buddha Nagar
UTTAR PRADESH |
8826140073
nits.pnd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E78||Disorders of lipoprotein metabolism and other lipidemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Oral route of administration
Centesimal scale 30 pill size
LM scale liquid form
First dose at the time of case taking
Subsequent doses according to follow ups
Intervention duration is atleast 6 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed cases of Dyslipidemia according to National Cholesterol Education Programme
Age group 18-54 years of both sexes
Participants undergoing allopathic medication but with no improvement
Participants willingly giving consent for participation |
|
| ExclusionCriteria |
| Details |
Participants with systemic diseases or immunocompromised conditions
Participants with severe psychiatric issues
Participants took homoeopathic medicines in past 3 months
Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that there will be lowering of parameters of Lipid profile after intervention which will be reflected in blood reports on comparing at baseline and at 6 months |
15 months study
6 months enrollment period
6 months follow up period
3 months statistical analysis
first dose after case taking
subsequent doses as per follow ups
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
19/12/2024 |
| 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 is an exploratory study to assess the effect of individualized homoeopathic medicines in cases of Dyslipidemia among adultsSample size of the study is 32 It is expected that there will be lowering of lipid profile parameters after intervention on comparing the data of baseline and at six months. |