Prospective, Randomized, Multi-centric, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
This study is a multi-centre, multi-national, prospective, randomized, double-blind placebo-controlled study. The study lasts 12 weeks which includes 2 on-site visits and 2 remote visits. Primary objective is to compare the efficacy of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety. Secondary objectives to compare the safety of KSM-66 Ashwagandha (Withania somnifera) versus placebo in adults experiencing high stress and/or anxiety.
详细描述
To qualify for this study, subjects must report experiencing high stress or anxiety in the past few months. Subjects must be between 18 to 65 years of age. Subjects must be non-smoking. Subjects must be in generally healthy condition with no serious illnesses, which might interfere with study participation. Subjects are required to maintain usual dietary habits for the duration of the study.
Up to 50 participants will be enrolled in this study at the SF Research Institute (SFRI) site. Approximately half of the subjects will be randomized to receive test treatment supplements, KSM-66, designed to improve anxiety and stress. And the other half of subjects will be randomized to receive placebo (a pill in appearance of test treatment supplement, but is harmless, ingredient of starch powder). This study will require subjects to return questionnaires and remaining test products (via USPS mail or drop off in person if you are able) to the testing facility (Address: 2345 Ocean Ave, San Francisco, CA 94127) by the end of eight weeks testing.
After signing this consent form, subjects will answer questions regarding their medical history, including any medications they are taking. Physical exams with vital signs (pulse, temperature, sitting blood pressure and respiratory rate) will be performed at both visits by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist, or Medical Doctor. In order to be qualified to participate this study at initial Visit (Baseline), BMI score range between 20-35 are required.
A blood sample will be required from subjects. Subject's right or left arm will be used as the blood draw site, requiring a 5mL sample. The blood will be analyzing Cortisol level. These blood draws will be administered by a professional trained to perform this testing. It may be a Nurse (RN or LPN), Phlebotomist or Medical Doctor.
A two-page Hamilton Anxiety Rating Scale (HAM-A) Test and Perceived Stress Scale (PSS) will be given and administered as self-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (male and female) aged between 18 and 65 years
- •Experiencing signs and symptoms suggestive of high stress (e.g., difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion etc.)
- •Hamilton Anxiety Rating Scale (HAM-A) total score between14 and 30 at the screening/randomization visit
- •Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit
- •BMI between 20 and 35
- •No plan to commence new treatments over the study period
- •Non-smoker
- •Medication-free (any medications known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pill are permissible.
- •Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •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.
- •Patients having total score less than 14 on HAM-A at screening.
- •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.
- •Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
- •Patients with known post-traumatic stress disorder (PTSD)
- •Patients who have an established practice of meditation and relaxation techniques for three or more months
- •Patients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
- •Patients with history of alcohol, tobacco dependence or with any substance abuse
- •Pregnant and lactating women or suspected to be pregnant
- •Patients with known hypersensitivity to Ashwagandha
- •Patients who had participated in other clinical trials during previous 3 months
- •Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: 8 weeks
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety)
次要结局
- Perceived Stress Scale (PSS)(8 weeks)
- Clinical Global Impression-Improvement scale(8 weeks)
- serum cortisol(8 weeks)