| CTRI Number |
CTRI/2025/11/097142 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of homoeopathic medicines on dyslipidemia in 20 to 65 years of age |
|
Scientific Title of Study
|
A Comparative study on the effectiveness of Moringa oleifera and individualised homoeopathic medicine in the management of Dyslipidemia |
| 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 Thara Sabu |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical Colllege,Trivandrum |
| Address |
Department of Organon of Medicine,Government Homoeopathic Medical College, Iranimuttom, Manacaud P. O, Trivandrum
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8590332440 |
| Fax |
|
| Email |
tharakappalumakkal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preema E P |
| Designation |
Professor and head of the department |
| Affiliation |
Government Homoeopathic Medical College, Trivandrum |
| Address |
Department of Organon of Medicine, Government Homoeopathic Medical College, Iranimuttom, Manacaud P. O, Trivandrum
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8547714025 |
| Fax |
|
| Email |
preemariyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thara Sabu |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical Colllege,Trivandrum |
| Address |
Department of Organon of Medicine, Government Homoeopathic Medical College, Iranimuttom, Manacaud P. O, Trivandrum
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8590332440 |
| Fax |
|
| Email |
tharakappalumakkal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Thara Sabu |
| Address |
Department of Organon of Medicine, Government Homoeopathic medical College,Iranimuttom Manacaud P.O, Thiruvananthapuram, Kerala,India
695009 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Thara Sabu |
Government Homoeopathic Medical College, Thiruvananthapuram |
Department of Organon of Medicine Government Homoeopathic Medical College,Iranimuttom, Manacaud P.O, Thiruvananthapuram 695009
Kerala, India
Thiruvananthapuram
KERALA |
8590332440
tharakappalumakkal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE,THIRUVANANTHAPURAM IRANIMUTTOM, MANACAUD P.O THIRUVANANTHAPURAM 695009 INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualised homoeopathic medicine |
Individualised homoeopathic medicine given to second group and reviewed at an interval of 2 to 4 weeks for 3 months |
| Intervention |
Moringa oleifera |
Moringa oleifera of different potencies given to first group and reviewd at an interval of 2 to 4 weeks for 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases satisfying diagnostic criteria where total cholesterol is less than 350 mg/dl.
2. Patients of both sexes
3. Patients in the age group of 20–65 years. |
|
| ExclusionCriteria |
| Details |
1. Cases with other serious illnesses and comorbidities.
2. Cases using lipid lowering drugs and other drugs that affect the lipid metabolism.
3. Cases with total cholesterol more than 350 mg/dl |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in lipid profile values are evaluated especially LDL and HDL levels. |
Values are reviewed at an interval of 2 to 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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 3 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="0"
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
|
A Prospective quasi experimental study will be conducted at Government Homoeopathic Medical College, Thiruvananthapuram over a period of one year. 46 patients aged between 20 and 65 years with total cholesterol below 350 mg per dl will be selected and divided into two groups. One group will be given Moringa oleifera and the other individualised homoeopathic medicine. The study aims to evaluate and compare the effectiveness of moringa oleifera and individualised homoeopathic medicine in managing dyslipidemia. |