CTRI/2023/07/054711已完成3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the impact of the Investigational Product (IP) on stress levels by using the Hamilton Anxiety Rating Scale
研究概览
简要总结
The purposed study is a Phase III, randomized, double-blind, two-arm, placebo-controlled clinical study to assess the safety and efficacy ofAshwagandha extract in patients with stress and anxietyhaving cardiovascular comorbidities. The study is proposed to be conducted at single site in India to recruit approximately 60 number of patients to meet the objective of this study. Primary outcome of this study is to assess the impact of the Investigational Product on stresslevels by using the Hamilton Anxiety Rating Scale and secondary outcome is to assess the impact of the Investigational Product on Unspecified Anxiety Disorder along with cardiovascular comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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 ≥
- •â‰¤ 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 GAD ≥ 5 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.
排除标准
- •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.
- •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.
结局指标
主要结局
To assess the impact of the Investigational Product (IP) on stress levels by using the Hamilton Anxiety Rating Scale
时间窗: Day 30 and Day 60 from the baseline
次要结局
- To assess the impact of the IP onUnspecified Anxiety Disorder (DSM-5(300.00; ICD-10 F41.9 resp. ICD-11 6B0Z) along with following)
研究者
研究点 (1)
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