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"Chou's Tiaoshen" Acupoints for Short-term Insomnia.

NCT06212934 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-01-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the curative effect of "Chou's Tiaoshen" acupoints in short-term insomnia and the explore the possible mechanism of the action. The main questions it aims to answer are:

* Whether the curative effect of caupuncturing"Chou's Tiaoshen" acupoints in the treatment of short-term insomnia is not inferior to that of Esazolam.
* What is the possible mechanism of acupuncture "Chou's Tiaoshen"acupoints for short-term insomnia.

Participants with short-term insomnia who met the criteria will be randomly assigned to "Chou's Tiaoshen"acupoints group and Esazolam group. Polysomnography, heart rate variability, cortisol and related scales will be measured before and after treatment to detect the changes in symptoms and signs before and after treatment.

Conditions

  • Short-term Insomnia

Interventions

OTHER

Acupuncture

"Chou's Tiaoshen" acupoints includes Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1), Sanyinjiao (SP-6), Shenmen (HT-7) . Using stainless steel needles (0.32×40)mm, HuaTuo, China). Then some other points like, Danzhong(CV-17), Daling(PC-7), Taixi (KI-3), Qihai (CV-6), Taichong (LR3), and Qiuxu(GB-40) are chosen. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1) are punctured at a depth of 20-25mm obliquely. Sanyinjiao (SP-6) and Shenmen (HT-7) are inserted 15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known as "De Qi"; Technique: Mild reinforcing and attenuating, retaining the needle for 30minutes. The treatment will be givenonce a day and 5 times a week in weekdays, the course will last two weeks.

DRUG

Estazolam

Participants will take estazolam 1mg 30min prior to bedtime everyday. The course of treatment is two weeks.

Sponsors & Collaborators

  • Beijing Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Huanqin Li, Doctor · Beijing Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2025-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212934 on ClinicalTrials.gov