Health Condition 1: - Health Condition 2: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: 3% Arjunoglucoside: Two tablets, containing 375 mg each of 3% Arjunoglucoside twice a day, b.i.d
Control Intervention1: Placebo: Two tablets of Placebo of equal weight, twice a day, b
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female of 35 to 65 years old, both inclusive. 2.Atherogenic index of plasma > 0.1 3.BMI >= 30 kg/m2 4.Total cholesterol > 200mg/dL; LDL > 150mg/dL; Serum Triglyceride > 150mg/dL; HDL Cholesterol 5.Blood Pressure - Systolic 140-159 mm Hg and/or diastolic 90-99 mm Hg ( Grade 1 hypertension) 6.Females with child-bearing potential who agree to use barrier method of contraception throughout the study period. 7.Patients must be willing to come for regular follow-up visits. 8.Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating or female having the intention to be pregnant within next three months. 2.Do not agree to stop Smoking & Alcohol intake during the study duration 3.BMI > 40 kg/m2 4.Subjects having history of diabetes (Type I or Type II) 5.Fasting Blood Glucose >= 126 mg/dl and HbA1c >= 7%. 6.Patients undergoing any other regimen apart from the prescribed standard management 7.Having untreated BP of systolic = 160 mmHg and diastolic 100 mmHg. 8.Patients having Lactose intolerance. 9.Liver dysfunction (serum bilirubin > 1.5 times upper limit of normal or serum transaminase > 2 times upper limit of normal 10.Patients having neurodegenerative & major psychiatric disorders 11. Subjects with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR of 60 or less) 12.A history of significant multiple and/or severe allergies or anaphylactic reactions 13.Patient with known history of hypersensitivity to the investigational product 14.Patient has participated in any clinical trial within last 3 months 15.Any other condition which the Principal Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Blood pressure - systolic and diastolic blood pressure 2. Non HDL cholesterol /Cholesterol Ratio 3. Apolipoprotein A1 4. Apolipoprotein B 5. Apo B : Apo A1 6. Atherogenic index of plasma Timepoint: 1. Baseline to Final visit 2. Screening to Final visit 3.Baseline to Final visit 4. Baseline to Final visit 5. Baseline to Final visit 6. Screening to Final visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of 3% Arjunoglucoside on lipid parameters 2. To evaluate the effect of 3% Arjunoglucoside on FBS and HbA1c 3. Mean change in hs-CRP 4. Safety evaluation of 3% Arjunoglucoside upon occurrence AE and significant change in laboratory parameters.Timepoint: 1. Screening & day 90 2. Screening & day 90 3. baseline & final Visit 4. screening & final visit | — |
Countries
India
Contacts
Public ContactDr Alphons Philips
Sami-Sabinsa Group limited
Outcome results
None listed