Effect of Moxibustion Intervention on 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

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Moxibustion
• Intervention / Treatment: Device: Traditional Chinese moxibustion apparatus

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JING Cai, Undergraduate; Phone Number: 13524000307; Email: 1994510cj@163.com
• Study Contact Backup: Name: JianMing Zhang, graduate student; Phone Number: 18017311232; Email: 18017311232@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）
      • Contact: Yi Mei, Undergraduate; Phone Number: 18017311269; Email: 18017311269@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The study group(using the moxibustion); The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.; 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.; 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.; The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.	Device: 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.; 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.; 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.; The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.
Placebo Comparator: The control group(using the moxibustion with blank patch); The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.; 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.; 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.; The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.	Device: 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.; 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.; 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.; The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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%.	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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2022-YJ14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No