A Single Centre, Double Blind, Placebo-controlled Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress in Subjects with Mild to Moderate Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
研究概览
简要总结
A single centre, double blind, placebo-controlled clinical study design in healthy subjects to evaluate the efficacy of dietary supplement to alleviate stress in subjects with mild to moderate stress
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must complete pre-study assessment questionnaire and have a minimum stress level score of ≥
- •The subject is a healthy male or female 25-55 years of age at the time of informed consent.
- •The subject must have a BMI of ≥18.5 and ≤30.0 kg/m2 and be willing to have their height and weight measured.
- •No reported history of psychological or mental disorders.
- •Free of anti-depressants/anti-anxiety/mood enhancing/recreational drugs (e.g., marijuana, THC, CBD) intake for at least 6 months prior to screening.
- •Free of any 'over the counter' or prescribed medications except for female participants taking contraceptive pills.
- •Agree to abstain from smoking, vaping, or using recreation drugs (e.g., marijuana, THC, CBD) during the study.
- •Willing and able to give informed consent.
排除标准
- •Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
- •Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.
- •Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
- •Having taken anti-depressants/anti-anxiety/mood enhancing/ recreational drugs (e.g., marijuana) within 6 months prior to screening.
- •Having smoked, vaped, or used recreational drugs (e.g., marijuana, THC, CBD) within the last 6 months prior to screening.
- •Having any known chronic skin conditions that may be exacerbated with using a topical product.
- •Pregnant, planning to become pregnant or nursing.
- •Any known allergy or intolerance to any of the ingredients contained in supplements or topical product.
- •Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results.
- •Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, and atopic dermatitis.
- •Individuals currently taking certain medications which in the opinion of the investigators may interfere with the Study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antihypertensive drugs, antibiotics, or other topical drugs at the test sites.
- •Individuals who have routinely used an alpha-hydroxy-acid (AHA) or a betahydroxy-acid (BHA) containing product within two weeks or Retin-A®, Retin-A Micro®, Renovar®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of the Study start or have taken Accutane® within one year of the Study start.
- •Individuals who have used Retinol in the last six months.
- •Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site.
- •Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical.
- •Individuals taking high dose biotin (i.e., >5 mg / > 5000 μg per day).
- •Individuals who work night shifts.
结局指标
主要结局
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
时间窗: 30 days
Hamilton Anxiety Rating Scale (HAM-A) (1) was assessed using a questionnaire and scored on a scale of 0 to 4, with 0 (no presence of anxiety) to 4 (severe anxiety). (1) Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 1959, 32, 50-55.
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
时间窗: 30 days
Hamilton Depression Rating Scale (HDRS) (1) was assessed using a questionnaire and scored using a scale of 0 to 20, with 0-7 (within normal range or remission) while a score of 20 (indicating moderate depression. (1) Hamilton, M. A rating scale of depression. J. Neurol. Neurosurg. Psychiatry, 1960, 23, 56-62.
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)
时间窗: 30 days
Perceived stress was assessed with Perceived Stress Scale (PSS) using a validated questionnaire on a score of 0 to 40, with 0 (no stress) and 20 or above (higher perceived stress) at day 1, day 7 and at day 30.
次要结局
- Assessment of mood using Profile of Mood States (POMS) scale(30 days)
- Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale(30 days)