| CTRI Number |
CTRI/2016/09/007273 [Registered on: 12/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the Efficacy and Safety of Garlixir TM capsules (250 mg or 500 mg) in Hyperlipidemia patients |
|
Scientific Title of Study
|
A prospective, randomized, double blind, three-arm, parallel group, placebo controlled clinical Study to evaluate the Efficacy and Safety of Garlixir TM capsules (250 and 500 mg) in hyperlipidemia patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/BE/0129/54 Version 01 Dated 29-Jan-2016 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajanna Muniswamappa BAMS MS AYU |
| Designation |
Physician |
| Affiliation |
Bangalore Diabetes Center |
| Address |
#426,IV Cross,II Block,Kalyan Nagar,
Bangalore
KARNATAKA
560043
India |
| Phone |
9880367101 |
| Fax |
|
| Email |
dr.rajanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBIO Clinical Research PVT LTD |
| Address |
ICBio Clinical Research Pvt. Ltd. #16,18 ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director-Operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16,18 ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Bio-gen Extracts Pvt. Ltd. |
|
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Primary Sponsor
|
| Name |
Biogen Extracts Pvt Ltd |
| Address |
Plot No. 57, 1st Stage, Sompura Industrial Area,Bangalore 562 111, Karnataka, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajanna Muniswamappa |
Bangalore Diabetic Center |
#426,4th cross, 2nd block Kalyannagar
Bangalore
KARNATAKA |
9880367101
dr.rajanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medisys Clinisearch Ethical Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garlixir TM capsule 250 mg |
One Capsule two times a day before breakfast and dinner for 84 days |
| Intervention |
Garlixir Tm capsules 500 mg |
One Capsule two times a day before breakfast and dinner for 84 days |
| Comparator Agent |
Placebo |
One Capsule two times a day before breakfast and dinner for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient meeting the requirements of any one of the following parameters:-
.Total cholesterol (201-239 mg/dl),
.LDL-C (130-159 mg/dl),
.Triglycerides (161-230 mg/dl).
2.Patients willing to give a written informed consent along with audio video visual and willing to visit the site for a regular follow up.
3.Patients willing to abide by and comply with the study protocol requirements & restriction
BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2)
4.Patient should be non-alcoholic.
5.Patients willing to abstain from usage of any NSAIDs during the study duration
6.Patients willing to abstain from heavy exercise (Jogging, Weight lifting etc.) during the study duration
|
|
| ExclusionCriteria |
| Details |
1.Patients with history or presence of
.Any clinically significant Respiratory system disorders
.Central nervous system disorders
.Reproductive system disorders
.Gastro intestinal disorders & having problems in swallowing or digesting.
.Diabetes (type I or II) or history of gestational diabetes
.Heart disease
.Active neoplasm’s
.Renal or liver disease
.Hyperthyroidism or Hypothyroidism
2.Patients who are pregnant, lactating or nursing.
3.Patients currently advised or are on lipid lowering medications (known to affect lipid metabolism, platelet function, or antioxidant status)
4.Patients currently advised or are on blood pressure medications.
5.Patient undergoing the following medications
.Protease inhibitors (e.g., indinavir, saquinavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs such as nevirapine, efavirenz), isoniazid,
.Blood Thinners such as warfarin and heparin
.Anti-platelet drugs such as Aspirin & clopidogrel
.Calcium channel blockers including diltiazem
.Azole antifungals including ketoconazole, Fluconazole etc
.Medications with Garlic Supplements.
.Patients using oral contraceptives & Steroids.
.Patients smoking 20 or more cigarettes per day (Heavy smokers)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Total Cholesterol Screening, Day 42, and Day 84 (End of the treatment).
•LDL Cholesterol Screening, Day 42, and Day 84 (End of the treatment).
•Triglycerides Screening, Day 42, and Day 84 (End of the treatment).
|
Screening, Day 42, and Day 84 (End of the treatment).
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| •Incidence and rate of adverse events |
Screening, Day 42, and Day 84 (End of the treatment).
|
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2016 |
| Date of Study Completion (India) |
21/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A prospective, Randomized, Double blind , three arm , parallel Group, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Garlixir TM capsule (250 mg or 500 mg) in Hyperlipidemia Patients.
The Main Objective of the study is to evaluate the Efficacy of Garlixir TM Capsule In Hyperlipidemia patients by evaluating the Changes in Laboratory parameters :- Total Cholestrol, LDL Cholestrol, And Triglycerides from Screening to EOT
The secondary objective of the study is to Evaluate the safety of Garlixir TM capsule in Hyperlipidemia patients by recording the Incidence and rate of adverse events from Screening to EOT
In this trial total number of subjects is 78 and they will be follow up for 12 weeks.
The data will be analyzed with 5% significance level and 80% power for study using SAS.
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