| CTRI Number |
CTRI/2024/01/062141 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Fucus homoeopathic medicine in High blood cholesterol levels |
|
Scientific Title of Study
|
Prospective Clinical Study on Hyperlipidaemia patients treated with Fucus vesiculosus Q |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOWJANYA B |
| Designation |
PG SCHOLAR |
| Affiliation |
vinayaka missions homeopathic medical college |
| Address |
Room No. 3d1, Medical Unit-IV, PG Department of Practice of Medicine, Ground Floor,OPD Block,Vinayaka Missions Homeopathic Medical College and Hospital,NH-47,Sankari Main Road,Seeragapadi PO, Salem,
Salem
TAMIL NADU
636308
India |
| Phone |
7780579683 |
| Fax |
|
| Email |
sowjanya.baragada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVenkatesan H |
| Designation |
Professor, Head of Department and Guide |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No. 3d1, Medical Unit-IV, PG Department of Practice of Medicine, Ground Floor,OPD Block, Vinayaka Missions Homeopathic Medical College and Hospital,NH-47,Sankari Main Road,Seeragapadi PO, Salem,
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOWJANYA B |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No. 3d1, Medical Unit - IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homeopathic Medical College and Hospital, NH-47, Sankari Main Road, Seeragapadi PO,
Salem
TAMIL NADU
636308
India |
| Phone |
7780579683 |
| Fax |
|
| Email |
sowjanya.baragada@gmail.com |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSIONS HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL, NH-47, SANKARI MAIN ROAD, SEERAGAPADI PO, SALEM, TAMILNADU - 636308 |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSIONS HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
NH-47,SANKARI MAIN ROAD, SEERAGAPADI PO, SALEM, TAMILNADU - 636308 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DRSOWJANYA B |
VINAYAKA MISSIONS HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Room No. 3d1, Medical Unit-IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homeopathic Medical College and Hospital, NH-47, Sankari Main Road, Seeragapadi PO, Salem
Salem
TAMIL NADU |
7780579683
sowjanya.baragada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FUCUS VESICULOSUS Q |
5 drops in 10 ml water - 3 times a day for 5 Months to each Patient |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Hyper Lipidemia patients with both High Cholesterol and Tri-glyceride levels.
Patients of age between 25 years and 75yrs |
|
| ExclusionCriteria |
| Details |
Patients with history of comorbic conditions like CHD,
Patients undergoing long term and continuing treatment for hypaerlipidemia
Pregnant females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood cholesterol levels ( LDL,HDL,VLDL), Reduction in tri-glycerides |
5 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Simon Broom diagnostic criteria for Familial Hyper cholesterolemia |
5 Months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There are over three million adults throughout the united states and europe that currently have a diagnosis of hyperlipidemia , Dyslipidemia is the most important atherosclerotic risk factor .Review on population based studies in india shows increasing mean total cholesterol levels .Recent studies have reported that high cholesterol is present in 25 -30%of urban and 15 - 20% rural subjects . In homeopathy many studies have contributed for the effectiveness of homeopathic management of hyperlipidemia treated with different homoeopathic mediciones like Cholesterinum , Cardus , Lycopodium , Fucus vesiculosus .Among those remedies fucus vesiculosus is a less explored remedy and Fucus have a high nutritional value and is considered as a good source of dietary fibres and minerals especially iodine .Homoeopathic action of this medicine on hyperlipidemia is well established .yet no scientific studies have been conducted and reported on this.These details intended to undertake a research study on the hyperlipidemia treated with fucus
|