CTRI/2022/04/042212已完成4 期
An open label, multicentric, prospective, non-randomized, phase-IV post-marketing, surveillance study to evaluate the efficacy and safety of Zero Tension Tablet in individuals suffering from mild to moderate stress, anxiety and insomnia disorders - Zero Tension Tablet
ALNA BIOTECH PVTLTD0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adults in the age of 18-60 years.
- •2. Subjects with general good health as determined by the investigator.
- •3. Individuals presenting with mild to moderate stress, anxiety and insomnia disorders and further fulfilling one or both of the following criteria:
- •a. Score of 17-24 on the Hamilton-A Scale
- •b. A score 14-26 on the Perceived Stress Scale (PSS)
排除标准
- •1. Individuals who have taken prior medication for stress or anxiety in the last three months.
- •2. Individuals with comorbid conditions such as thyroid disorders, uncontrolled hypertension and uncontrolled diabetes mellitus.
- •3. Individuals with mental disorder such as Schizophrenia, Alzheimerââ?¬•s disease etc, except anxiety and insomnia.
- •4. Individuals with significant and uncontrolled acute or chronic coexisting illness related to cardiovascular, respiratory, gastrointestinal, immunological, metabolic, endocrinology, neurological system or any other condition which in the investigatorââ?¬•s judgement contraindicate entry into the study.
- •5. History of taking (within 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anticonvulsant, centrally acting corticosteroids, opioid pain relievers) hypnotics, narcotic analgesics, antidepressants, anticonvulsants, sedating H1 antihistamines, over-the-counter and prescriptions stimulants, decongestants, melatonin, drugs for oral alkalization, and all other drugs or supplements known to affect sleep cycle.
- •6. A known history or present condition of allergies that may require medical attention.
- •7. History or present case of alcohol or drug dependence (illicit drug users)
- •8. Present case of smoking and self-declared illicit drug users (including cannabis and cocaine)
- •9. Individuals suffering from PCOS or PCOD.
- •10. Subjects not willing to stop the use of another product similar to the test product during study period.
- •11. Subjects who are pregnant or are planning to get pregnant during the course of the study.
研究者
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