A Non Randomized Single Arm Study to Evaluate the Safety and Efficacy of Cread AM an Ayurvedic Formulation to Manage Stress and Anxiety in Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1) To evaluate the efficacy of Cread AM in improving Anxiety in Adults as measured by General Anxiety Disorder 7 (GAD 7) scale from Screening to the end of the study (assessments at Day 1 and Day 56).
研究概览
简要总结
Stress and anxiety are among the most prevalent mental helath concerns worldwide, significantly impacting quality of life, cognitive function, and overall well being. The administrtion of Cread AM , an Ayurvedic formulation is expected to provide significant benefits in managing stress and anxiety while maintaining favourable safety profile.The current study aim to evaluating the safety and efficacy of Cread AM in managing stress and anxiety.
Primary objectives is to evaluate the efficacy of Cread AM in improving anxiety in adults as measured by GAD-7 scale from screening to end of visit and to assess the efficacy of Cread AM in managing stress levels in adults as measured by PSS scale from screening to end of visit.
Secondary objectives is to evaluate the impact of Cread AM on stress using serum cortisol levels day-1 and day-56, to monitor safety parameters at day-1 to day-56 and to assess the safety and tolerability of Cread AM throughout the study period by evaluating clinical and laboratory parameters.
The study will include 3 visits- Screening visit- Viist-1- Informed concent form, Demogarphic details, Medical history, General physical examination, Vital signs, Safety laboratory examinations, PSS and GAD-7 scores, Testproduct dispensing, Instructions for the next visit, Visit-2 -Telephonic Visit- Compliance of the testproduct, Instructions for the next visit and Visit-3- End of visit- General physical examination, Vital signs, PSS and GAD-7 scores, Compliance and retrival of the test product.
Cread AM will be administered as 460mg capsule taken orally twice daily for a total duration of 56 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female adults aged between 18 and 60 years.
- •Individuals presenting (at least 2 weeks) with mild to moderate stress and anxiety disorders as per DSM-V-TR Diagnostic Criteria and further fulfilling the following criteria: A score 10-26 on the Perceived Stress Scale (PSS)
- •Women of child-bearing potential willing to use an adequate method of contraception to avoid pregnancy throughout the study period
- •Willing to sign inform consent document and abide by the study procedures.
排除标准
- •Chronic alcoholics consuming more than 2 standard pegs per day.
- •Subjects with known hypertension or other cardiovascular diseases diseases.
- •However controlled case of hypertension with stable dosages medication can be enrolled in the study
- •Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions.
- •Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening).
- •Subjects currently taking medications other than oral contraceptives.
- •Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol.
- •Individu als with acute narrow angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning.
- •Individuals with any diagnosable mental health disor der in the past 6 months or those currently taking psychotropic medications or other herbal preparations.
结局指标
主要结局
1) To evaluate the efficacy of Cread AM in improving Anxiety in Adults as measured by General Anxiety Disorder 7 (GAD 7) scale from Screening to the end of the study (assessments at Day 1 and Day 56).
时间窗: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)
2) To assess the efficacy of Cread AM in in managing stress levels in adults as measured by Perceived Stress Scale (PSS) scale from Screening to the end of the study (assessments at Day 1
时间窗: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)
and Day 56).
时间窗: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)
次要结局
- 1) To evaluate the impact of Cread AM on stress using Serum(Cortisol levels at Day 1 and Day 56)
研究者
Dr Geetha L
Ayuryog Ayurvedic Centre