| CTRI Number |
CTRI/2025/09/094518 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on homeopathic treatment of abnormal lipid levels in adult age group |
|
Scientific Title of Study
|
Assessment of the effectiveness of individualized homoeopathic medicines as an add on therapy compared to conventional treatment in the management of dyslipidemia in adult age group 18-65 years |
| 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 Chetana Nandkishor Dhomane |
| Designation |
PG STUDENT |
| Affiliation |
Student |
| Address |
Pg student department of homoeopathic materia medica Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8551003533 |
| Fax |
|
| Email |
chetana.dhomane8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetana Nandkishor Dhomane |
| Designation |
PG STUDENT |
| Affiliation |
Student |
| Address |
pg student department of homoeopathic materia medica ground floor Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
8551003533 |
| Fax |
|
| Email |
chetana.dhomane8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaphekar P A |
| Designation |
Professor and HOD department of homoeopathic materia medica |
| Affiliation |
|
| Address |
Department of homoeopathic materia medica ground floor Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9423580018 |
| Fax |
|
| Email |
priyagauri.chaphekar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD Ipd cpmplex department of homoeopathic materia medica ground floor Dr D Y Patil Homoeopathic medical college and research centre pimpri pune 411018 maharasthra India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Chetana Nandkishor Dhomane |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
8551003533
chetana.dhomane8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre Institutional Ethics Committee |
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 |
Individualised homoeopathic medicines |
Individualised homoeopathic medicines with ongoing conventional treatment |
| Comparator Agent |
Placebo |
placebo with Conventional Medicine going on |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Impression of abnormal values in blood test-lipid profile and liver function test
Adult age group 18-65 years
Triglycerides level 150-499 mg/dL
Low Density Lipoprotein level- 100-189 mg/dL
High Density Lipoprotein level 40-60 mg/dL
|
|
| ExclusionCriteria |
| Details |
Below 18 years and above 65 years
Triglyceride level above 500 mg/dL
Low Density Lipoprotein level above 190 mg/dL
High Density Lipoprotein level below 40 mg/dL
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the changes in lipid profile test and liver function test |
To see the changes in lipid profile test and liver function test in 3-4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patients on the basis of lipid profile test and liver function test |
To assess the patients on the basis of lipid profile test and liver function test in 3-4 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/10/2025 |
| 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 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
|
Study will be done on patients who are diagnosed with Dyslipidemia with abnormal lipid parameters ie increase in Triglyceride Level or Low Density Lipoprotein Level or decrease in High Density Lipoprotein level along with ongoing conventional treatment Patients will be divided into 2 groups one group will be prescribed homoeopathic medicines and other group will be given placebo The outcome will be assessed on the basis of changes in lipid parameters and liver function test It is a comparative clinical trial double arm study |