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Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients The participants were enrolled according to the principle of randomization and single blindness, and the analysis was adjusted every quarter according to the research schedule. The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with only western medicine.
Clinical evaluation of the main efficacy indicators: The score of PSQI scale was assessed. The reduction rate of PSQI scale was ≥ 25% as effective, and the difference between the two groups was compared as the basis for evaluating the main efficacy indicators. The efficacy of insomnia symptoms was evaluated by the difference of PSQI score reduction rate between groups before and after intervention.
Secondary clinical outcome measures: Quality of Life Scale (SQLS), SF-36 scale, Clinical Gross Impression Scale (CGI), adverse reaction（TESS） .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study group(using the moxibustion) | Active Comparator | The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
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| The control group(using the moxibustion with blank patch) | Placebo Comparator | The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese moxibustion apparatus | Device | The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
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| Measure | Description | Time Frame |
|---|---|---|
| The score of PSQI | The reduction rate of PSQI scale ≥25% was regarded as effective, and the difference between the two groups was compared as the basis for evaluating the main therapeutic effect indicators. The efficacy of insomnia symptoms was evaluated by the difference in the reduction rate of PSQI scores between the two groups before and after the intervention. | Baseline, week two, week four, week eight |
| Measure | Description | Time Frame |
|---|---|---|
| The score of Quality of Life Scale (SQLS) | The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JING Cai, Undergraduate | Contact | 13524000307 | 1994510cj@163.com | |
| JianMing Zhang, graduate student | Contact | 18017311232 | 18017311232@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD） | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Baseline, week two, week four, week eight |
| The score of SF-36 scale | The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%. | Baseline, week two, week four, week eight |
| The score of Clinical Gross Impression Scale (CGI) | The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%. | Baseline, week two, week four, week eight |
| adverse reaction（TESS）evaluation | The score reduction rate was taken as the therapeutic grade standard, and the score reduction rate =[(pre-treatment score - post-treatment score) ÷ pre-treatment score]×100%. The score reduction rate after treatment was ≥ 75% for clinical recovery, 50%-75% for obvious effect, 25%-50% for effective, and < 25% for ineffective. Total response rate = (effective + effective + cured)/total cases *100%. | Baseline, week two, week four, week eight |
| D001523 |
| Mental Disorders |