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.

Biogen Extracts Pvt Ltd0 个研究点目标入组 78 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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)

发起方

Biogen Extracts Pvt Ltd