A randomized, double-blind, placebo-controlled study to evaluate effectiveness of a natural phytochemical formulation ARC23004, on stress, sleep and mood in Healthy subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- 1) Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A
研究概览
简要总结
This study will be conducted to evaluate effectiveness of a natural phytochemical formulation "ARC23004", on stress, sleep and mood in Healthy subjects. Sufficient number of subjects will be enrolled in the study to get 90 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening and randomization visit. Follow up visit 2 will be on 7 ± 2 days, Follow up visit 3 will be on 30 ± 2 days and end of study visit will be on 60 ± 2 days. Subjects will be screened for the eligibility criteria during screening visit.
The subjects will be randomized in the ratio of 1:1:1 where they will either receive test product 60 mg, test product 120 mg or placebo. Subjects will be instructed to take 1 capsule before bed orally. Primary endpoint will be Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A, on Perceived Stress and on sleep and also Bond-Lader VAS (Mood Rating Scale) (BL-VAS) from Baseline, Visit 3 and EOS. The secondary endpoint will be Hormonal changes in serum cortisol* between 6-8 am and at 4 pm, Serotonin, dehydro epiandrosterone sulphate (DHEA-S) and testosterone, Change in stress and anti-inflammatory biomarkers, Fasting blood glucose from Baseline, Visit 3 and EOS. Change in BP and pulse, Change in CBC and blood lipids and assessment of Global Quality of Life Scale in Baseline and EOS will be performed. Also the frequency and intensity of AEs will be demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Subject with either gender, age between 18-65 (inclusive of both) years.
- •Subject having normal 12 lead ECG.
- •The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- •Subject having a score of at least 14 on the Perceived Stress Scale (PSS), free of psychiatric conditions other than stress.
- •Subjects who usually take more than 30 min to fall asleep and habitually take subjective total sleep time of less than or equal to 6.5 h per night (for at least 3 nights per week), having daytime complaints associated with disturbed sleep, having habitual bedtime between 8.30 p.m. to midnight, and contained Body Mass Index between 18.5 and 29.9 kg/sq.
- •Subjects who have given voluntary, written, informed consent to participate in the study.
排除标准
- •Subjects suffering from any chronic physical, hormonal or psychiatric illness.
- •Subjects with uncontrolled type 2 diabetics, blood pressure and symptomatic hypotension and heart disease.
- •History of heart attack, stroke and coronary/cerebrovascular events.
- •Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- •History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
- •Subjects with previous history of surgery.
- •Pregnant and lactating women.
- •Subjects taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication, any supplementations that impact on mood, stress, and sleep.
- •Subjects currently taking any herbal preparations, nutritional formulations, foods or formulations (including teas) containing valerian, chamomile, peppermint, mint, saffron, lavender, passionflower, lemon balm, tulsi, GABA, melatonin, theanine, magnesium, Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs.
- •Subjects practicing lifestyle approaches such as yoga, breathing techniques, meditation, relaxation exercises, aromatherapy, relaxation tapes, etc to manage stress.
- •Subjects who regularly take stimulants including but not limited to coffee, tea, colas/ soda, caffeine, teacrine, paraxanthine, guarana, herbal stimulants, etc.
- •2-3 hours before bed time.
- •Subjects who live in an environment that results in disturbed sleep patterns, e.g., household with small children/ babies that need attention in the night, noisy neighbourhoods, etc.
- •Subjects working in shift work.
- •Non – co-operative attitude of the subject.
- •Subjects with substance dependence including dependence on alcohol.
- •Subjects with allergies to any of the study product components.
- •Any condition that, in the opinion of the investigator, does not justify the subject’s inclusion for the study.
- •Excluding smokers since smoking can impact both perceived stress levels and sleep quality and anyone that consumes more than 2 drinks per day.
结局指标
主要结局
1) Impact of ARC23004 on Hamilton Anxiety Rating Scale HAM-A
时间窗: 60 days
2) Impact of ARC23004 on Perceived Stress
时间窗: 60 days
3) Impact of ARC23004 on Sleep
时间窗: 60 days
4) Bond-Lader VAS (Mood Rating Scale) (BL-VAS)
时间窗: 60 days
次要结局
- 2) Change in stress and anti-inflammatory biomarkers (Cortisol between 6-8 am and at 4 pm, C-reactive protein (CRP), IL-6, TNF-a).(60 days)
- 1) Hormonal changes in serum cortisol between 6-8 am and at 4 pm, Serotonin, dehydro epiandrosterone sulphate (DHEA-S) and testosterone.(60 days)
- 3) Change in BP and pulse.(60 days)
- 4) Fasting blood glucose.(60 days)
- 5) Change in CBC and blood lipids(60 days)
- 6) To assess Global Quality of Life Scale.(60 days)
- 7) To demonstrate safety and tolerability of study product by clinical monitoring of adverse events.(60 Days)
研究者
Dr Milan Satia
Ethicare Clinical Trial Service