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临床试验/NCT02565316
NCT02565316已完成2 期

Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Shiraz University of Medical Sciences0 个研究点目标入组 70 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
70
主要终点
Persian version of Beck Anxiety Inventory (BAI)

研究概览

简要总结

The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial. A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who having depression according to Persian-language version of the Beck Depression Inventory-Second edition and get score above 11 according to Persian version of Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation, allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism and patients who used substances or alcohol and patients who had indication for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having depression according to Persian-language version of the Beck Depression Inventory-Second edition
  • get score above 7 according to Persian version of Beck Anxiety Inventory (BAI)

排除标准

  • pregnancy and lactation
  • allergy to N. menthoides and Lamiaceae family
  • patients with suicidal thoughts or previous suicidal attempt
  • patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism
  • patients who used substances or alcohol
  • patients who had indication for electroconvulsive therapy -

研究组 & 干预措施

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

Active Comparator

干预措施: Nepeta menthoides Boiss & Bohse freeze dried extract (Drug)

Sertraline capsule

Active Comparator

干预措施: Sertraline (Drug)

结局指标

主要结局

Persian version of Beck Anxiety Inventory (BAI)

时间窗: 6 weeks

次要结局

  • side effects of intervention drugs(6 weeks)

研究者

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

Sepideh Kolouri

Shiraz University of Medical Sciences

Shiraz University of Medical Sciences

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