Effect of Moxibustion Intervention on Insomnia Patients

NCT06171308 | Unknown

• 1 other identifier: 2022-YJ14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia; Moxibustion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The score of Quality of Life Scale (SQLS)

  Baseline, week two, week four, week eight

• The score of SF-36 scale

  Baseline, week two, week four, week eight

• The score of Clinical Gross Impression Scale (CGI)

  Baseline, week two, week four, week eight

• adverse reaction（TESS）evaluation

  Baseline, week two, week four, week eight

Study Arms (2)

The study group(using the moxibustion)

ACTIVE COMPARATOR

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.

Device: Traditional Chinese moxibustion apparatus

The control group(using the moxibustion with blank patch)

PLACEBO COMPARATOR

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.

Device: Traditional Chinese moxibustion apparatus

Interventions

Traditional Chinese moxibustion apparatus DEVICE

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 control group(using the moxibustion with blank patch); The study group(using the moxibustion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria of ICD-10 insomnia;
• 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);
• Pittsburgh Sleep Quality Index (PSQI) score \> 7 at baseline;
• The treatment plan used in this study is tolerable, cooperative and compliant;
• Regardless of gender, age 18-65 years old;
• Understand the procedure and content of the test, and voluntarily sign the informed consent;

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

moxibustion equipment（Zhongshan Jiaxun medical equipment Co., LTD）

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

JING Cai, Undergraduate

CONTACT

13524000307; 1994510cj@163.com

JianMing Zhang, graduate student

CONTACT

18017311232; 18017311232@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: December 14, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)