Clinical trial NCT06171308: Effect of Moxibustion Intervention on Insomnia Patients
Official title: Effect of Moxibustion Intervention on Insomnia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Moxibustion
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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） .

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of ICD-10 insomnia;
2. In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse);
3. Pittsburgh Sleep Quality Index (PSQI) score \> 7 at baseline;
4. The treatment plan used in this study is tolerable, cooperative and compliant;
5. Regardless of gender, age 18-65 years old;
6. Understand the procedure and content of the test, and voluntarily sign the informed consent;

Exclusion Criteria:

1. Participating in other clinical studies;
2. Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
3. there is a clear risk of suicide or danger to oneself or others;
4. Exclude pregnant or lactating women, or those planning pregnancy;
5. Persons with alcohol and drug dependence within 1 year prior to screening.

Primary outcomes:
measure: The score of PSQI
timeFrame: Baseline, week two, week four, week eight
Secondary outcomes:
measure: The score of Quality of Life Scale (SQLS)
timeFrame: Baseline, week two, week four, week eight
measure: The score of SF-36 scale
timeFrame: Baseline, week two, week four, week eight
measure: The score of Clinical Gross Impression Scale (CGI)
timeFrame: Baseline, week two, week four, week eight
measure: adverse reaction（TESS）evaluation
timeFrame: Baseline, week two, week four, week eight
Other outcomes:
Locations:
city: Shanghai
country: China
facility: moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）
state: Shanghai
Study officials:
References: