CTRI/2025/07/091819尚未招募Unknown
An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. Sukoon Tablets in patients having Stress Issues.
Jeena Sikho Lifecare Limited1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年8月8日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 2. EEG Score
研究概览
简要总结
An open label single arm study.
Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.
Patients will be assigned to investigational product for 30days, following up on 1st and 15th and 30th day.
Subject from 18-65 years
Test Product: Shuddhi Dr. Sukoon Tablets
Dose: 1-1 Tablet (BD)
Route of Administration: Oral
Duration: day 1st , 15th and 30th
· Perform the following assessments
o SGA
o EEG
o QOL(DASS-21)
研究设计
- 研究类型
- Observational
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 from 18-65 years of age.
- •Subject suffering from one or multiple mental health Issues from- anxiety, insomnia, mood disorder etc.
- •Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •Subjects that have participated in any other interventional clinical trial in the previous 90 days.
- •Subjects with known sensitivity to any of the constituents of the investigational product.
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •Pregnant/nursing mothers.
结局指标
主要结局
2. EEG Score
时间窗: Day 1, Day 15, Day30
1. SGA(Subject Global Assessment) score
时间窗: Day 1, Day 15, Day30
3. Change in mental QOL Score (DASS-21).
时间窗: Day 1, Day 15, Day30
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Raakhee Mehra
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur
研究点 (1)
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