A clinical trial to study the effects of Ashwagandha in patients with stress and anxiety having cardiovascular comorbidities.
Phase 3
Completed
- Conditions
- Generalized anxiety disorder,
- Registration Number
- CTRI/2023/07/054711
- Lead Sponsor
- Dr. Willmar Schwabe India Pvt. Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of the Investigational Product (IP) on stress levels by using the Hamilton Anxiety Rating Scale Day 30 and Day 60 from the baseline
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hi-Tech Medical College and Hospital
🇮🇳Khordha, ORISSA, India
Hi-Tech Medical College and Hospital🇮🇳Khordha, ORISSA, IndiaDr Amrit PattojoshiPrincipal investigator91-9438148100dramritp@yahoo.com