Effect of Moxibustion Intervention on Insomnia Patients

Last updated: December 6, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Traditional Chinese moxibustion apparatus

Clinical Study ID

NCT06171308
2022-YJ14
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet the diagnostic criteria of ICD-10 insomnia;
  2. In line with the relevant diagnostic criteria of TCM syndrome differentiation ofheart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria accordingto the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment ofInsomnia 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 informedconsent;

Exclusion

Exclusion Criteria:

  1. Participating in other clinical studies;
  2. Exclude patients with serious physical diseases or diseases that may affect theevaluation 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

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Traditional Chinese moxibustion apparatus
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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) .

Connect with a study center

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

    Shanghai, Shanghai
    China

    Active - Recruiting

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