A Prospective, Randomized, Double-Blind, Parallel, placebo-controlled Clinical lnterventional Study to Evaluate the Safety and Efficacy of zenroot Ashwagandha 1.5% on Stress, Anxiety and Mood in Subjects with Stress.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean change from baseline on stress as assessed by Perceived Stress Scale
研究概览
简要总结
stress is a common problem faced by everyone in day-to-day life from different sources like job, family problems, pollution, noise etc. Stress is a condition arising from external physical or mental overload. It can make a person feel embattled, nervous, anxious, or otherwise less capable of a full and normal response to environmental demands.
The study is A Prospective, Randomized, Double-Blind, Parallel, Placebo-controlled Clinical Interventional Study to Evaluate the Safety and Efficacy of Zenroot Ashwagandha 1.5% on Stress, Anxiety and Mood in Subjects with Stress.This herb has been studied as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardioprotective, thyroid modulating, immunomodulating, antibacterial, antifungal, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic agent. Ashwagandha contains a range of bioactiveslike withanolides, sitoindosides and other alkaloids that are pharmacologically and medicinally important. These protect the cells from oxidative damage and diseases.
Considering all the benefits of Ashwagandha cited above, the present study will be conducted to evaluate the efficacy of the Zenroot Ashwagandha 1.5% Capsules its adaptogenic properties to reduce stress and its associated features. Additionally, Zenroot Ashwagandha 1.5% capsules will also be evaluated for its positive impact on anxiety, mood, impaired sleep quality due to stress, cortisol and alpha-amylase lowering property.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Stressed male or female adults aged between 18 to 55 years (both limits inclusive).
- •BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive).
- •Subjects with mild to moderate stress as determined by a score ≥7 or ≤26 on the PSS.
- •Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period.
- •Subjects willing to refrain from taking any medications or preparations for addressing stress or anxiety or mood (herbal, dietary supplements, homeopathic preparations, etc.) during the study.
- •Subjects willing to refrain from consuming alcohol 24 hours prior to the test days.
- •Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days
- •Subjects willing to refrain from vigorous physical activity 12 hours prior to test days.
- •Subjects who agree to stay weight stable during the study period.
- •Subjects who agree to have a minimum 7–8-hour sleep before the visit days and during the study period.
- •Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject).
- •Subjects willing to provide written consent.
- •Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
- •Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
- •Subjects with a psychiatric diagnosis including anxiety or depression
- •Subjects with sleep disturbances and/or are taking sleep aid medication
- •Subjects having hypersensitivity or history of allergy to the study product
- •Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications
- •Subjects with a history of drug and /or alcohol abuse at the time of enrolment
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
- •Subjects with positive Urine Pregnancy Test prior randomization
- •Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
- •Subjects with severe stress based on PSS score greater than 26
- •Subjects with uncontrolled hypertension -systolic blood pressure greater 160 mm Hg or diastolic blood pressure greater 100 mm Hg at screening
- •Excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater than or equal to 3 cups of caffeinated coffee/day) throughout the study period.
结局指标
主要结局
Mean change from baseline on stress as assessed by Perceived Stress Scale
时间窗: Baseline and End of Study (Day 84)
次要结局
- Mean change from baseline on stress biomarkers - serum cortisol levels, and salivary(alpha-amylase)
研究者
Dr Manasvi M
Bengaluru Neuro Centre