Health Condition 1: E787- Disorders of bile acid and cholesterol metabolism
Conditions
Interventions
Intervention1: Policosanol
(PO2404): Dose: 22mg
Dosage form: Capsules
Frequency: one capsule per day after dinner
Duration:8 Weeks
Control Intervention1: Placebo: Dose: 22mg
Dosage form: Capsules
F
Sponsors
Cell Green Biolab Co., Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males and females aged between 30-60 years who are willing to given written informed consent. 2. Individuals with LDL cholesterol in normal (100-129 mg/dL), and borderline/alert (130-159 mg/dL). 3. Subjects who are willing and able to understand and follow the protocol and provide informed consent. 4. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications and supplement during the course of this study.
Exclusion criteria
Exclusion criteria: 1. Medication a. Drug addicts b. More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks. c. Consumption of cholesterol related medicines and treatment in the past 4 years d. Subjects whose blood chemistry parameters (Hematology and Biochemistry) are not within normal range. e. Diagnosed with high blood lipids and prescribed medication to improve blood lipids f. Taking drugs that affected body weight (fat absorption inhibitors and appetite suppressants, health food supplements related to obesity, psychiatric drugs such as depression, beta-blockers, diuretics, contraceptives, steroids, and female hormones) within the last month g. Have been diagnosed with hepatitis and are taking antiviral medications h. Use of Astemizole, Nedocromil, Cromolyn, long acting beta agonists, Ketotifen, Theophylline or testosterone within 4 weeks before. 2. Disease Condition a. eGFR less than 60 mL/min/1.73m2 factor b. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate) hematology, serum chemistry c. Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments. d. ALT, AST is more than 3 times the upper limit of normal. e. Patients with any illness or chronic disease in the last 3 years necessitating long-term medication f. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological) g. Subjects suffering from any serious medical or surgical illness. h. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ. i. Those who have undergone surgery within last 6months. 3. Other general conditions (physiological, lifestyle, allergic reactions, etc.) a. Pregnant and lactating women or those planning to become pregnant b. Allergies/adverse reactions to study substances c. Alcohol consumption (greeter than 40 g/day for men and greeter than 20 g/day for women (based on WHO guidelines for daily alcohol consumption) d. Excessive smokers (greeter than 20 cigarettes/day) e. Use of dietary supplements related to the function within 3 months prior to the start of the study f. Participation in another clinical trial within the last 3 months g. Those who are judged to be unsuitable for the study by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is 1.Percentage change in total cholesterol, low-density lipoprotein (LDL) cholesterol, triglyceride (TG), and high-density lipoprotein (HDL) cholesterol). 2.Percentage reduction in apolipoprotein, CETP, 7-alphahydroxylase 3.Percentage reduction in urine cholesterol Timepoint: Lipid Profile : Day 0 Week 4 and Week 8 7-alpha-hydroxylase Biomarker- Apolipoprotein, CETP : Day 0 Week 4 and Week 8 Urine Cholesterol: Day 0 and Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is to evaluate the safety of Policosanol (PO2404) & consumer acceptance.Timepoint: Day 0 Week 4 & Week 8;Safety Endpoints 1. Adverse events (AEs). 2. Abnormal findings in vital signs and medical interviews. 3. Abnormal changes in the hematology/blood chemistry test resultsTimepoint: Day 0 Week 4 and Week 8 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed