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临床试验/TCTR20230711006
TCTR20230711006尚未招募2 期

Effects of herbal formula from Dillenia species extract for insomnia person: a double-blinded randomized controlled trial.

ational Innovation Agency (NIA) and Sciseeit.Co, Ltd.0 个研究点目标入组 80 人开始时间: 2023年7月11日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80

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

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • 1. Male or female with age from 18 to 70 years old
  • 2. Participants who diagnosed as insomnia by DSM-V assessment criteria.
  • 3. Patients who understand Thai language and be able to communicate with the research teams
  • 4. Participants who willing to participate the study

排除标准

  • 1.Participants who experienced allergy to oleamide, Dillenia extract or other ingredients of the product.
  • 2.Pregnant or breastfeeding woman
  • 3.Patients who had an obstructive sleep apnea: OSA.
  • 4.Participant with abnormal liver function (AST, ALT > 3 times higher than normal).
  • 5.Participants with chronic kidney disease or acute kidney injury (GFR < 30 ml/min/1.73m2).
  • 6.Prticipant with BMI more than 30 (which is a risk to occur an OSA).
  • 7.Participants with other underlying diseases or medical problems that would interfere with the study such as a heart disease, schizophrenia, moderate to severe depression or anxiety that required treatment with other medications
  • 8.Participant who treating insomnia with other methods beside those prescribed in this study.
  • 9.Patients who are using medications or products that affect sleep quality (such as antianxiety, antihistamine, hemp, marijuana, amphetamine, stimulant, beta-blockers, steroids, theophylline etc.) 14 days before the study.

研究者

发起方
ational Innovation Agency (NIA) and Sciseeit.Co, Ltd.

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