Effect of Moxibustion Intervention on Insomnia Patients

Shanghai Mental Health Center

Status: Enrolling

Conditions: Moxibustion; Insomnia

Treatments: Device: Traditional Chinese moxibustion apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT06171308

2022-YJ14

Details and patient eligibility

About

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

Full 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） .

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

The study group(using the moxibustion)

Active Comparator group

Description:

The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine. 1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.

Treatment:

Device: Traditional Chinese moxibustion apparatus

The control group(using the moxibustion with blank patch)

Placebo Comparator group

Description:

The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine. 1. The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 2. The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment. 3. The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.

Treatment:

Device: Traditional Chinese moxibustion apparatus