An interventional study of facial acupuncture and facial scraping in Insomnia, sponsored by Pei Yuan. Not yet recruiting. Open to participants aged 16 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Pei Yuan · Not applicable, Interventional, and Treatment
Insomnia is one of the most common mental disorders and has shown an upward trend in recent years. The commonly used western medicine treatment methods are easy produce drug-related adverse reactions, and there are problems such as the decline of efficacy and the production of drug dependence after long-term medication. Traditional Chinese medicine treatment of insomnia on syndrome differentiation. In this study, taking the common heart and spleen deficiency syndrome and liver depression transforming into fire syndrome as examples, based on the theory of zangfu andingluo, we explored the selection of acupoints for acupuncture treatment of insomnia and conducted clinical efficacy observation. Combined with the analysis of the changes of Pittsburgh Quality Index, Hamilton Anxiety Scale, Traditional Chinese Medicine Syndrome Efficacy Rating, Infrared Thermal Image Acquisition, Forehead Adhesive Sleep Recorder and other data, the acupuncture treatment of insomnia patients was expounded.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 82 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Procedure: facial acupuncture
Procedure: facial scraping
Acupuncture at specific points, each time leaving the needle for 30 minutes, twice a week, for four weeks.
Scrape the specific areas of the face, each time for 15-20 minutes, twice a week, with an interval of at least 2, for 4 weeks continuously, a total of 8 times.
Pittsburgh Sleep Quality Index
There are 19 sleep-related self-assessment questions that make up 7 components ranging from 0 to 3 points. The total score evaluation is: 0 to 5. Good sleep quality. 6 to 10. The sleep quality is okay. 11-15 Sleep quality is average; The sleep quality from 16 to 21 was very poor. The PSQI score reduction rate = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. Cure: PSQI score reduction rate ≥75%. Effective rate: 50%≤ deduction rate \< 75%. Effective: 25%≤ deduction rate \< 50%. Invalid: PSQI deduction rate \< 25%. The total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients)/Total number of patients in this group of trials ×100%
Time frame: Week 4
Traditional Chinese Medicine Syndrome Efficacy Assessment
According to the "Diagnostic and Therapeutic Criteria for Symptoms of Traditional Chinese Medicine", 11 observation indicators for insomnia of the heart andleen deficiency type were formulated. The TCM syndrome scoring table consists of 11 symptoms including sleep, dreaminess, palpitation, asthenia, dizziness,orexia, abdominal distension, loose stool, complexion, tongue image, and pulse condition. The first four items are scored according to 0, 2, 4 and 6 points, and the remaining seven items are scored according to 0-3 points, with a full score of 45 points. The higher the score, the consistent the symptoms are with the heart and spleen deficiency type.
Time frame: Week 4
Hamilton Anxiety Scale
The table includes 14 items, all of which adopt a 5-point scoring method of 0-4 points, 0 points: asymptomatic 1 point: mild; 2 points: moderate; 3 points: severe; 4 points: extremely severe.
Time frame: Week 4
Infrared thermal image acquisition
Compare the average temperature (℃) of the forehead and abdomen before and after treatment. A decrease in temperature after treatment indicates effectiveness. Through infrared thermal imaging, the sleep line on the forehead: ａ．Significantly effective: the sleep line completely disappears; ｂ．Effective: the sleep line changes from bilateral to unilateral;Ｃ．Ineffective: the sleep line does not change significantly. The total effective rate of sleep line improvement = (number of significantly effective cases number of effective cases) / number of cases × 100.0%.
Time frame: Week 4
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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