Clinical effect of Acupuncture Pretreatment on sleep deprivation and the mechanism of immune protein regulatio

Not Applicable

Recruiting

• Conditions: Sleep deprivation

• Registration Number: ITMCTR2100004430
• Lead Sponsor: Changchun University of Traditional Chinese Medicine

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: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy young male volunteers aged 18-30 years;
2. The body mass index of subjects with body weight over 45kg was 18.5-23.9;
3. The subjects should not have any congenital defects or chronic diseases within 3 years before enrollment, and should not have any pathological or abnormal clinical findings in physical examination, such as severe primary diseases of cardiovascular system, lung, liver, kidney and hematopoietic system;
4. Subjects with no sleep disorder and Pittsburgh sleep quality index (PSQI) score < 5;
5. Subjects with SDS score <= 50 and SAS score <= 53;
6. Seven days before the start of the first clinical trial, participants must maintain normal night sleep time (between 21:00 and 09:00);
7. Seven days before the start of the first clinical trial, participants must sleep at least seven hours every night;
8. Non smoking subjects;
9. The subjects who voluntarily sign the written informed consent;
Note: those meeting the above 9 items at the same time will be included.

Exclusion Criteria

1. Subjects who regularly drank alcohol (> 210g / week) within 6 months before enrollment. Beer (5% v / V): 250ml = 10g, Shaojiu (20% v / V): 50ml = 8g, wine (12% v / V): 125ml = 12g);
2. Subjects who participated in another clinical study within 2 months before enrollment;
3. Subjects who had donated whole blood within 2 months before enrollment, or had donated blood components within 1 month before enrollment;
4. Subjects with sitting systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg at the time of screening;
5. Subjects who took prescription or non prescription drugs within 7 days before the first clinical trial;
6. Subjects who had drinking history of caffeine, tea and wine within 7 days before the first clinical trial;
7. Subjects who had received acupuncture treatment for any disease within 7 days before enrollment;
8. Subjects with severe skin infection, weak constitution and a history of acupuncture sickness at acupoints;
Note: any one of the above items is excluded.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Encephalofluctuograph Technology;The Positive and Negative Affect Scale (PANAS);Fatigue Severity Scale (FSS);Profile of Mood States (POMS);Stanford Sleepiness Scale (SSS);Face Reader;Brief Fatigue Inventory (BFI);

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index (PSQI);Intelligent management system of healthy sleep (TPF);Self-Rating Anxiety Scale (SAS);Self-rating depression scale (SDS);Sleep diary;Safety indicators, such as blood routine, second stool routine, coagulation function, liver function, kidney function, electrocardiogram, etc.;