Effect of Moxibustion Intervention on Insomnia Patients

Not Applicable

Recruiting

• Conditions: Moxibustion; Insomnia
• Interventions: Device: Traditional Chinese moxibustion apparatus

• Registration Number: NCT06171308
• Lead Sponsor: Shanghai Mental Health Center

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） .

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The control group(using the moxibustion with blank patch)	Traditional Chinese moxibustion apparatus	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.
The study group(using the moxibustion)	Traditional Chinese moxibustion apparatus	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.

Primary Outcome Measures

Name	Time	Method
The score of PSQI	Baseline, week two, week four, week eight	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.

Secondary Outcome Measures

Name	Time	Method
The score of Quality of Life Scale (SQLS)	Baseline, week two, week four, week eight	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%.
The score of SF-36 scale	Baseline, week two, week four, week eight	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%.
The score of Clinical Gross Impression Scale (CGI)	Baseline, week two, week four, week eight	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%.
adverse reaction（TESS）evaluation	Baseline, week two, week four, week eight	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%.

Trial Locations

Locations (1)

moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）; 🇨🇳 Shanghai, Shanghai, China