A randomized, double-blind, two-arm, placebo-controlled Phase III clinical study to assess the safety and efficacy of Ashwagandha extract in patients with stress and anxiety having cardiovascular comorbidities.

Dr. Willmar Schwabe India Pvt. Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年9月18日

试验速览

暂无简介。

•Male and female subjects =18 and = 65 years old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ - SF)
•People who have a history or clinical diagnosis of a pre-existing hypertension
•BMI of = 18 - = 34.9 kg/m2
•Having at least three of the following five metabolic risk factors:
•i. Waist circumference > 94 cm (40 inches) for men and > 80 cm (35 inches) for women
•ii. Fasting triglycerides > 150 mg/dL
•iii. Blood pressure =130 mm Hg (Systolic Blood Pressure)
•and/or =85 mm Hg (Diastolic Blood Pressure)
•iv. Fasting blood glucose = 100 mg/ dl
•v. Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women)
•HAM-A total score = 18
•All participants will be encouraged to not make any major lifestyle changes during the study period.
•They will be informed that any major changes may result in exclusion from the study.
•Participants willing to provide written informed consent.

•History of myocardial infarction since 1 year.
•Heart failure symptoms greater than New York Heart Association Functional Class II.
•Hemodynamically significant valvular or left ventricular (LV)
•tract obstruction.
•Subjects without a pacemaker and with any of the following:
•i. Sinus bradycardia ( < 50 bpm)
•ii. Sick sinus syndrome
•iii. Atrioventricular block of more than 1st degree
•Syncopal episodes presumed to be due to uncontrolled life threatening arrhythmias.
•Planned cardiac surgery or coronary angioplasty within 6 months of screening.
•History of recent non-haemorrhagic stroke or transient ischemic attack (TIA), history of haemorrhagic stroke.
•Hyperthyroidism.
•Known chronic liver disease or end stage renal disease.
•Severe, symptomatic benign prostatic hyperplasia which may require surgery.
•Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
•Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain or any other anxiolytic agents.
•Treated hypertension stabilized for less than 3 months.
•Morbid obesity (BMI > 40 Kg/m2).
•Subjects with a blood pressure range of systolic = 180 mm Hg and diastolic = 120 mm Hg.
•Nursing or pregnant women

发起方