Sensoril® - Cardiovascular/Endothelial
Dysfunction Clinical Study
Study Design
Prospective, randomized, double blind study with placebo and positive
(Atorvastatin/Lipitor®) controls with 20 subjects in each group.
Patients with Type 2 diabetes stabilized on Metformin treatment
Inclusion Criteria
Patients of either sex, aged 18-75 years
Fasting plasma glucose of ≥110 mg/dL
Glycosylated haemoglobin (HbA1c) between 7 % and 9%
Taking stable dose of anti-diabetic treatment for the past 8 weeks prior to the
screening visit
Endothelial dysfunction defined as ≤ 6% change in reflection index (RI) on post
salbutamol challenge test
Exclusion Criteria
Patients with severe uncontrolled hyperglyceamia, uncontrolled hypertension,
cardiac arrhythmia, impaired hepatic or renal function, history of malignancy or
stroke, smoking, chronic alcoholism, any other serious disease requiring active
treatment and treatment with any other herbal supplements and pregnant and
lactating women.
15
CONFIDENTIAL
Sensoril® - Cardiovascular/Endothelial Dysfunction
Clinical Study – Demographics & Dosage Regimen
N
Parameter Placebo
Sensoril
250 mg
Sensoril
500 mg
Atorvastatin
N
20
20
20
20
Age
57.45±8.85
55.40±8.07
57.30±9.40
56.95±8.04
Sex (M/F)
12/8
14/6
13/7
13/7
Weight (Kg)
66.09±5.56
68.07±6.51
67.30±6.16
68.56±8.47
BMI (Kg/m
2
)
24.82±1.86
24.89±2.03
25.01±2.92
26.02±3.12
Duration:
12 weeks
Sensoril®:
250mg and 500 mg twice daily
Atorvastatin:
One capsule of Atorvastatin 10mg (night) and one capsule of Placebo (morning)
Placebo:
One capsule of placebo twice daily
16
CONFIDENTIAL
