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Completed
NCT05682911
Protective Effect of Zingiber Officinale L. Extract in Hypertensive Patients
Conditions: The Main Focus of This Study is to Evaluate the Safety of Zingiber Officinale L. Tablets as Hypolipidemic Agent in Hypertensive Patients
Sex: All
Ages: 18 Years – 65 Years
Phase: EARLY_PHASE1
Enrollment: 40
Sponsor: Jinnah Sindh Medical University
Location: Pakistan
Summary
Hyperlipidemia is a well-known risk factor for cardiovascular diseases (CVDs).
Coronary heart disease, stroke, and atherosclerosis are among the primary cause of death.
Various medicines are available for the treatment of hyperlipidemia however, they are linked with serious unwanted effects.
Zingiber officinale L. extract (Ginger) was used in folklore medicine as a hypolipidemic agent, Although, its clinical trial studies were not been investigated in the Pakistani population yet.
Our clinical study is the first to assess the hypolipidemic, antioxidant, and cardioprotective effect of ginger tablets on dyslipidemic patients regarded as important risk factors for cardiovascular morbidity.
A total of 40 dyslipidemic patients of age (18-65 years) of either sex were recruited in Al-Khidmat Hospital Karachi and allocated into two groups; the Simvastatin group (20 mg OD) and the Ginger treated group (500mg Ginger tablets BD) for 2 months.
At baseline, their Blood pressure (BP), heart rate (HR), Insomnia severity index (ISI), Minimental state examination (MMSE), Lipid profile, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), creatine kinase (CK-MB), C-reactive protein, Superoxide Dismutase (SOD) & Glutathione Peroxidase (GPx) were recorded and repeated after 2 months of follow-up.
Eligibility Criteria
Inclusion Criteria:Males and females (18-65)Diagnosis of primary hypercholesterolemiaWith total cholesterol 200-239mg/dl and LDL 100-159mg/dl.Exclusion Criteria:Familial hypoalphalipoproteinemiaPatients receiving antihyperlipidemic agents (Statins, Niacin, Fibrates and Bile Sequestrants) were excluded in recent past.Pregnant, breast feeding and women likely to become pregnantSubjects excluded who suffered from allergy or hypersensitivity from Ginger or its tablet excipients.All those subjects excluded with severe or unstable medical conditions like renal failure, Seizures, previous liver surgery, poor controlled diabetes, and drug/alcohol dependence.
Source: ClinicalTrials.gov (NCT05682911). StuddyBuddy aggregates publicly available trial information.