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临床试验/CTRI/2020/11/028937
CTRI/2020/11/028937已完成2 期

Evaluation of Efficacy and Safety of AshwaDaat® Capsule in subjects with Stress and Insomnia â?? An Open label, multi center, non-comparative, interventional, prospective clinical study - NI

ODAAT PHARMA0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30

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.Subjects who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)
  • 2.Subjects not having any psychiatric conditions other than stress
  • 3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

排除标准

  • 1.Subjects suffering from any chronic physical, hormonal or psychiatric illness
  • 2.Subjects on treatment for stress and insomnia
  • 3.Subjects using oral or systemic contraceptive medications
  • 4.Subjects with uncontrolled diabetes and hypertension
  • 5.Subjects with substance dependence
  • 6. Chronic alcoholics and Habitual Tobacco chewers.
  • 7.Known cases of Severe/Chronic hepatic or renal disease.
  • 8.Known case of any active malignancy.
  • 9.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.
  • 10.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  • 11.Known case of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
  • 12.Subjects using any other investigational drug within 1 month prior to
  • recruitment or Subjects currently participating in any other Clinical study
  • 13.Known hypersensitivity to any of the ingredients used in study drug
  • 14.Pregnant and Lactating females.
  • 15.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

研究者

发起方
ODAAT PHARMA

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