CTRI/2022/12/048354尚未招募未知
A Randomized, Double-Blind, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Viwithan in Healthy, Stressed Adult Subjects.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subjects with Hamilton anxiety scale scoring between 6 and 17.
- •2.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
- •3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1. Subjects with history of
- •Diagnosable mental health disorder e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia
- •Severe neurological diseases or seizures
- •Uncontrolled / serious medical illness including diabetes, liver disease, hypertension
- •Cardiac Disease/Neurological Problems/
- •Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes)
- •Gastrointestinal tract bleeding / peptic ulcer disease
- •Acute narrow angle glaucoma
- •Prostate hypertrophy
- •2. Subjects with known hypersensitivity to Ashwagandha extract or allergic to any of the natural constituents of the Investigational Product.
- •3. Known HIV or Hepatitis B positive or any other immuno-compromised state
- •4. Subjectâ??s currently (or within the past 6 months prior to screening) taking any psychotropic medicines (e.g. anti-depressant, benzodiazepine, antipsychotic or mood-stabilizer, MAO inhibitor) or herbal preparation.
- •5. Subjects having symptoms of viral infection, including COVID-19 infection
- •6. History of smoking, alcohol/drug abuse
- •7. Subjects visually or mentally handicapped or having difficulty to communicate
- •8. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •9. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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