CTRI/2024/12/077984尚未招募不适用
Role of Ashwagandha Root Extract (ARE) in Stress and Anxiety in Healthy Adults: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean change in score for
研究概览
简要总结
•All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
•Subjects will be informed about the purpose of the study and signed informed consent will be taken.
•Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (week 12).
•All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, visit 3 (week 8) ± 4 days, and visit 4 (week 12) ± 4 days.
•The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1.Adults (male and female) aged between 18 and 65 years.
- •2.Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
- •3.Participants with a Perceived Stress Scale (PSS) score ≥13 and without any other psychiatric conditions.
- •4.BMI between 20 and 35 kg/m
- •5.No plan to commence new treatments over the study period.
- •Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks.
- •Use of analgesics (once a week) or contraceptive pills will be permissible.
- •7.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •1.Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
- •2.Patients currently (or within the past 4 weeks prior to screening) taking any over-the-counter use of herbal extracts such as Ginkgo Biloba, St. John’s Wort, Omega-3, etc.
- •3.Patients with a depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia, and mania.
- •4.Patients with known post-traumatic stress disorder (PTSD) and Generalized Anxiety Disorder (GAD).
- •5.Patients who have an established practice of meditation and relaxation techniques for three or more months.
- •6.Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
- •7.Patients with a history of alcohol, tobacco dependence, or any substance abuse.
- •8.Pregnant and lactating women or suspected to be pregnant.
- •Patients with known hypersensitivity to Ashwagandha.
- •Patients who had participated in other clinical trials during the previous 3 months.
- •Patients who have any clinical condition, according to the investigator, do not allow safe fulfilment of clinical trial protocol.
- •Participants having any chronic physical, haematological, hormonal, or psychiatric illness and history of substance dependence.
结局指标
主要结局
Mean change in score for
时间窗: Baseline, Week 4, Week 8, Week 12
Profile of Mood States (POMS, abbreviated version) questionnaire and Patient Reported Outcomes Measurement Information System (PROMIS-29) questionnaire from baseline.
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.(Baseline, Week 4, Week 8, Week12)
- Mean change in scores for Oxford Happiness Questionnaire (OHQ) questionnaire from baseline.(Baseline, Week 4, Week 8, Week 12)
- • Mean change in scores for Pittsburgh Sleep Quality Index (PSQI) questionnaire from baseline.(Baseline, Week 4, Week 8, Week 12)
- Mean change in stress hormone (Sr. cortisol) from baseline.(Baseline, Week 12)
- Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.(Baseline, Week 12)
- Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.(Baseline, Week 12)
- Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.(Baseline, Week 4, Week 8, Week 12)
- Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks(Baseline, Week 4, Week 8, Week 12)
研究者
DrRajesh Yashwant Patil
Gautami Nursing Home
研究点 (1)
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