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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1 Evaluate efficacy of Ashwagandha in terms of decrease in score of Perceived Stress Scale (PSS)
研究概览
简要总结
A Prospective, Single centre, open label, single Arm Non-Comparative Study. For the primary endpoint (PSS), assuming an effect size of 0.55 will be attained during the study, the estimated number of subjects to be enrolled are 28 that can provide the desired effect with 95% confidence and 80% power of paired t-test. Informed consent will be obtained from the patients before enrolling in the study. The screening period will be -7 days. All 25 enrolled participants will receive the investigational product Ashwagandha DSTR Capsule along with SoC throughout the study duration.
Patients’ eligibility will be confirmed based on their medical history. Eligible patients then will be enrolled in single arm. Treatment will be given to patients for 12 weeks and One week followed by End of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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.
- •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.
- •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.
结局指标
主要结局
1 Evaluate efficacy of Ashwagandha in terms of decrease in score of Perceived Stress Scale (PSS)
时间窗: 1 from Screening visit to End of treatment (week 12)
次要结局
- 1 Depression anxiety and stress as measured by decrease in score of Depression and Anxiety Stress Scale 21(2 Evaluate efficacy of Ashwagandha in terms of decrease in score of Hamilton- Anxiety)
研究者
Dr Bhushan Chowdhary
Eras Bharti Hospital