CTRI/2024/06/069402
尚未招募
未知
A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of Ashwagandha DSTR Capsule in Subject with Moderate Stress Mild Anxiety Depression Low Stamina and Strength - NI
M/s Synthite Industries Private Limited0 个研究点目标入组 0 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: F430- Acute stress reaction
- 发起方
- M/s Synthite Industries Private Limited
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Include both male and female, age between 18\-60 years.
- •2\.Score on the 10\-item Perceived Stress Scale (PSS) ranging from 14 to 26 at the time of screening.
- •3\.Free of psychiatric conditions other than stress, anxiety, mild to moderate depression and cognitive deficits in moderately stressed subjects as per the discretion of the Investigator.
- •4\.Self\-reported moderate stress, mild anxiety, or depression
- •5\.Willing and able to provide written informed consent prior to performing study procedures.
- •6\.Participants experiencing reduced stamina and strength, as assessed by subjective reporting.
- •7\.Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods.
- •8\. Subjects willing to comply with the protocol requirements.
排除标准
- •1\.Suffering from any chronic physical, hormonal or psychiatric illness.
- •2\.Currently taking any herbal preparations or formulations for stress management (containing Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs).
- •3\.Drug abuse or aberrant laboratory findings during the screening. Medical history of clinically diagnosed severe depression, psychiatric disorder.
- •4\.Currently taking mood stabilizer, anti\-psychotic, anti\-convulsion or any opioid –based analgesics.
- •5\.Allergy or sensitivity to any of the ingredients in the study treatment.
- •6\.Subjects with serious, critical illness, or severe mental illness.
- •7\.Any other condition, which the Principal Investigator thinks, may jeopardize the study.
- •8\.Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and/or known history of Hepatitis B virus (HBV), defined by presence of hepatitis B surface antigen (HBsAg) and/or known history of Hepatitis C virus (HCV), defined by presence of hepatitis C antibody (HCVAb).
- •9\.Pregnant or lactating women.
- •10\.Taking any of the following classes of medications: benzodiazepines, central nervous system depressants, immune suppressors, cardiovascular medication.
结局指标
主要结局
未指定
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