跳至主要内容
临床试验/CTRI/2025/07/090721
CTRI/2025/07/090721招募中不适用

Clinical Effectiveness of Medha Vati Extra Power in the Management of Stress and Anxiety: Prospective, Open Label, Single Arm, Observational Study.

Patanjali Research Foundation3 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
61
试验地点
3
主要终点
Improvement in Stress and Anxiety assessed by the change in Depression Anxiety Stress Scales 21 scores.

研究概览

简要总结

This is a prospective, open label, single arm, observational study. Subjects will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. Eligible subjects will take Medha Vati Extra Power Tablet for 60 days. The  Improvement in Stress and  Anxiety assessed by the change in Depression Anxiety Stress Scales 21 scores from baseline to Day 7. In Perceived stress scale and Hamilton Anxiety Rating Scale from baseline to Day 30 and Day 60.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Subjects with complaints of Stress and/or Anxiety.
  • Hamilton Anxiety Rating Scale total score 14 or higher at the screening.
  • Perceived Stress Scale PSS 10 score 13 or higher at the screening.
  • Subjects must provide written informed consent to participate in the study.
  • Willing to do regular follow up.

排除标准

  • Subjects with depressive episode, suicidal tendency obsessive compulsory disorder schizophrenia and mania.
  • Subjects with history of alcohol smoking tobacco or with any substance abuse.
  • Subjects with severe hepatic renal cardiovascular or respiratory disease.
  • Pregnancy or breastfeeding.

结局指标

主要结局

Improvement in Stress and Anxiety assessed by the change in Depression Anxiety Stress Scales 21 scores.

时间窗: from baseline to day 7

次要结局

  • Improvement in Stress and Anxiety assessed by the change in Perceived Stress Scale and Hamilton Anxiety Rating Scale scores(from baseline to day 30 and Day 60)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Rakesh Dehari

Patanjali Wellness

研究点 (3)

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