Evaluation of therapeutic effect of thumbtack needle on high altitude insomnia

Phase 1

• Conditions: insomonia disorder

• Registration Number: ITMCTR2200006610
• Lead Sponsor: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Insomnia was diagnosed according to the insomnia disorder standard of the fifth edition of the diagnostic and Statistical Manual of mental diseases (DSM-V); 2. insomniac group inclusion criteria: ? Patients with insomnia as the main complaint, who meet the above diagnostic criteria and have typical symptom groups of insomnia; ? PSQI = 8 points; ? Age = 18 years old; ? They volunteered to participate in this study and signed informed consent.

Exclusion Criteria

? Those who combine with diseases that have not been effectively controlled or are extremely serious, such as persistent pain, malignant tumors, cardiovascular and cerebrovascular diseases, neuroendocrine diseases, neuromuscular diseases and digestive tract diseases caused by various reasons, resulting in insomnia disorders; Comorbid personality disorder or mental retardation; ? Those with severe depression and anxiety (SAS > 70; Self rating Depression Scale (SDS)>73); ? Use alcohol and / or other drugs or dependent drugs; ? Have suffered from depression or other mental diseases within 6 months before enrollment; ? Those who were treated with insomnia drugs within 1 month before enrollment; ? Those who participated in any other clinical trial within 1 month before baseline; ? Pregnant and lactating patients. ? Those who cannot cooperate with the treatment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of Pittsburgh sleep quality index before and after treatment;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome questionnaire;Self rating Depression Questionnaire;Metabonomics;Anxiety self rating questionnaire;