Clinical Observation of Facial Acupuncture for Insomnia Based on Zangfu Meridian Theory
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for insomnia in both Western and traditional Chinese medicine and the classification criteria for TCM syndrome differentiation;
- •Between 16 and 30 years old (including 16 and 30 years old);
- •No mental or language disorders;
- •PQSI score ≥ 7;
- •No hypnotic medication treatment within two weeks before the study;
- •Patient informed consent, and voluntarily participate in this.
排除标准
- •Those who do not meet the above inclusion criteria;
- •Those with secondary insomnia caused by organic diseases, mental diseases etc.;
- •Those who faint at acupuncture or refuse acupuncture;
- •Those who have received any facial acupuncture or thread embedding within 3 months;
- •Those who have received radiofrequency or laser wrinkle removal treatment within half a year;
- •Those who have received facial tissue filler injection and A-type botulinum toxin injection and other long-term facial rejuvenation treatment within one year;
- •Pregnant or lactating, those preparing for pregnancy during the treatment process;
- •Those who work night shifts for a long time, with irregular work and rest;
- •Those withocrine function, immune function diseases, and those with severe primary diseases of the heart, brain, liver, kidney and hematopoietic system;
- •Those who cannot cooperate with the treatment. Note: Those who meet any of the above items are not included in this trial.
研究组 & 干预措施
Facial acupuncture treatment group
干预措施: facial acupuncture (Procedure)
Facial scraping treatment group
干预措施: facial scraping (Procedure)
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: Week 4
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%
次要结局
- Traditional Chinese Medicine Syndrome Efficacy Assessment(Week 4)
- Hamilton Anxiety Scale(Week 4)
- Infrared thermal image acquisition(Week 4)
研究者
Pei Yuan
lecturer
Shanghai University of Traditional Chinese Medicine