NCT06171308

Effect of Moxibustion Intervention on Insomnia Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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） .

Conditions

• Insomnia
• Moxibustion

Interventions

Type	Name	Description
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. 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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: China