| CTRI Number |
CTRI/2020/07/026907 [Registered on: 29/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of KaraHeart for the management of cholesterol level in human participants. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to evaluate Efficacy and Safety of KaraHeart on the Lipid Profile of mild to moderate hyperlipidemia in subjects who are at risk for cardiovascular disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DGC/DF/01/19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sucharitha L |
| Designation |
Ayurvedic Physician |
| Affiliation |
Shettys Hospital |
| Address |
Dept. of Ayurveda,
Room No. 1, First Floor,
Plot No.11 &12, 12th F main, Kaveri Nagar, Bommanahalli
Bangalore
KARNATAKA
560068
India |
| Phone |
08025732886 |
| Fax |
|
| Email |
sucharitha.pandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrRajendran R |
| Designation |
Proprietor |
| Affiliation |
GreenChem |
| Address |
2030,1st Cross Rd, HAL 2nd Stage, Kodihalli,
Bangalore
KARNATAKA
560008
India |
| Phone |
08025269569 |
| Fax |
|
| Email |
rajendran22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Dheeraj Kumar Deep |
| Designation |
Head-Clinical Operations |
| Affiliation |
D2L Clinical Solutions Pvt. Ltd. |
| Address |
1st Floor,Nandi Infotech, KIADB Plot # 8,1st Cross, Sadaramangala Industrial Area, Mahadevpura Post
Bangalore
KARNATAKA
560048
India |
| Phone |
08030850666 |
| Fax |
|
| Email |
dheeraj@d2lclinical.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GreenChem |
| Address |
2030, 1st Cross Road, HAL 2nd Stage, Kodihalli,Bangalore-560008 |
| Type of Sponsor |
Other [Herbal & Ayurvedic Products Manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KARALLIEF INC |
One Mifflin Place, Cambridge, MA 02138, USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSucharitha L |
Shettys Hospital |
Plot No, 11 & 12, 12th F Main Rd, Kaveri Nagar, Bommanahalli
Bangalore
KARNATAKA |
08025732886
sucharitha.pandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shetty’s Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventative Interventions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KaraHeart (500mg) |
Synergistic composition of herbal extracts |
| Comparator Agent |
Placebo (500mg) |
Inert product with no health effect |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult men and women subjects between the age groups of 20–60 years with the confirmed case of mild to moderate hyperlipidemia.
2.As per ATP III guidelines; baseline LDL ranging >100 mg/dL, TC >200 mg/dL, TGL ranging 150-199 mg/dL, VLDL-Cholesterol >40 mg/dL, HDL-cholesterol: Men- <40mg/dL, and women -<50mg/dL
3.Subjects having all or at least any one of the diagnostic criteria mentioned above will be selected for the study.
4.Subjects with low BMI but abnormal lipid profile.
5.Subjects who are able to understand the risks/benefits of the protocol and are willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Subjects on concurrent lipid-lowering medications like statins, or fibrates, or dietary supplements within 30 days prior to screening.
2.Subjects suffering from Hyperlipidemia due to Consumption of drugs such as glucocorticoids.
3.Subjects with chronic diseases requiring continuous use of vasoactive,diuretics or lipid-lowering drugs.
4.Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain.
5.Subjects having history of any major illness of cardiovascular diseases eg.Angina pectoris, myocardial infarction etc.
6.Subjects having a history of thyroid disorder (TSH- levels of <0.4 or >10µg/dL), renal disorder, cholelithiasis or polycystic ovary syndrome (PCOS).
7.Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose 140-199 mg/dl.
8.Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 μmol/L, female 110 μmol/L). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from the baseline to the end of the treatment period in the levels of total cholesterol,High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL)and Triglyceride (TGL) |
Day 0, Day 30, Day 60, Day 90, Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein A1 |
Day 0 and Day 120 |
| Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein B |
Day 0 and Day 120 |
| Change from the baseline to the end of the treatment period in the level of Lipid peroxidation |
Day 0 and Day 120 |
| Change from the baseline to the end of the treatment period in the level of HbA1C |
Day 0 and Day 120 |
| Change from the baseline to the end of the treatment period in the level of C-Reactive Protein |
Day 0 and Day120 |
| Change from the baseline to the end of the treatment period in the level of Ankle Brachial reflex |
Day 0 and Day 120 |
| Change from the baseline to the end of the treatment period in the level of Total Cholesterol Vs HDL Cholesterol |
Day 0, Day 30, Day 60, Day 90, Day 120 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of KaraHeart versus placebo in improving the symptoms of hypercholesterolemia in otherwise healthy population aged between 20 to 60 years. The observed outcomes through primary and secondary endpoints results will be analysed to check the safety and efficacy of this synergistic herbal formulation. |