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临床试验/CTRI/2025/10/096681
CTRI/2025/10/096681尚未招募不适用

Effect of needling at acupuncture points (H7 and P6) and auricular points (Shenmen and Point Zero) on sleep quality in patients with insomnia: A randomized controlled trial

Government Yoga and Naturopathy Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

A Randomized controlled study design will be adopted in this study. All the eligible subjects will be randomly divided into 2 groups. Participants in the study group will receive a combination of needling at acupuncture points (H7 and P6) and auricular points (Shenmen and Point Zero), while the control group will undergo sham acupuncture, which involves superficial needling at non-acupuncture points on the body and shallow insertion in non-auricular sites for about for 20 minutes per session, 10 days for 2 weeks. Assessments will be performed before and after a two-week intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Insomnia Severity Index (ISI) score should be greater than 14 Willing to participate in the study Patients diagnosed with insomnia by using Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.

排除标准

  • Female participants who are pregnant or currently breastfeeding Individuals engaged in night shift work schedules Participants diagnosed with sleep apnea, narcolepsy, restless legs syndrome, or any chronic painful condition Regular Use of caffeine exceeding 600 mg per day History of alcohol or drug abuse.

研究者

发起方
Government Yoga and Naturopathy Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr M Sandhiya

Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai

研究点 (1)

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