CTRI/2022/05/042640招募中未知
To evaluate the efficacy and safety of Ashwagandha supplementation in improving quality of life and alleviating the symptoms in individuals with anxiety and depression; A double-blind, randomized, placebo-controlled study
SamiSabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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.Male or Female in the age of 18 to 60 years.
- •2.Hamilton Depression Rating Scale (HDRS) from 8 ââ?¬â?? 18.
- •3.Hamilton Anxiety Rating Scale (HARS) from 6-24.
- •4.Willingness to provide informed consent and comply with the trial protocol.
排除标准
- •1.Pregnant and lactating female or female having the intention to be pregnant within next three months.
- •2.Education level below 8th grade of schooling, Uncorrected visual impairment, food allergies/insensitivities; any hormonal status likely to induce an unstable/fluctuating emotional state (e.g., menopausal transition); presence of life event likely to induce unstable/fluctuating emotional state (e.g., change of professional function/ situation, death of a family member, divorce, surgery); worked night shifts.
- •3.Engaged in high levels of physical activity; consumed >500 mg caffeine per day;
- •current smokers and alcohol abusers.
- •4.Using medication or psychotherapy for depression.
- •5.Have major psychiatric, medical, or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle intervention
- •6.With chronic gastrointestinal diseases, severe immune deficiency.
- •7.Not on stable doses of medications for blood pressure for at least one month prior to starting study medication or having uncontrolled hypertension > 160/100 mmHg.
- •8.Not on stable doses of medications for diabetes for at least one month prior to starting study medication or having uncontrolled HbA1c > 7.5%.
- •9.Having a history of stroke.
- •10.History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies in the last one month.
- •11.History of acute medical/surgical complications which require hospitalization.
- •12.Participants with history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, heart valvular disease) haematological, hepatic (SGOT or SGPT levels > 2 Upper Limit of Normal), renal (serum creatinine ââ?°Â¥ 1.3 mg/dl), respiratory, or genitourinary abnormalities or diseases.
- •13.A history of significant multiple and/or severe allergies or anaphylactic reactions.
- •14.Participants with known history of hypersensitivity to the investigational product.
- •15.Participants who have participated in other clinical trial within last 3 months.
- •16.Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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