Health Condition 1: I00-I99- Diseases of the circulatory system
Conditions
Interventions
Intervention1: Garlixir Tm capsules 500 mg: One Capsule two times a day before breakfast and dinner for 84 days
Intervention2: Garlixir TM capsule 250 mg: One Capsule two times a day before breakfast
Sponsors
Biogen Extracts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 neoplasmâ??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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Total Cholesterol Screening, Day 42, and Day 84 (End of the treatment). â?¢LDL Cholesterol Screening, Day 42, and Day 84 (End of the treatment). â?¢Triglycerides Screening, Day 42, and Day 84 (End of the treatment). Timepoint: Screening, Day 42, and Day 84 (End of the treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Incidence and rate of adverse eventsTimepoint: Screening, Day 42, and Day 84 (End of the treatment). | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBIO Clinical Research PVT LTD
Outcome results
None listed