The Clinical Efficacy of patients with chronic insomnia (liver depression spleen deficiency) Treated by Herb-partitioned moxibustion on the navel

Phase 1

• Conditions: chronic insomnia

• Registration Number: ITMCTR2200005574
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Aged between 18 and 60 years (no gender limitation);
2.Comply with the diagnostic criteria for chronic insomnia in ICSD-3;
3.Comply with the diagnostic criteria for chronic insomnia in troditional Chinese Medicine and syndrome differentiation belongs to liver depression spleen deficiency;
4.Pittsburgh Sleep Therapy Index (PSQI)>5 points;
5.Understand and agree to participate in this study and sign the informed consent form.

Exclusion Criteria

1.Serious heart,lung, liver, kidney and other systemic diseases; or migraine, dysmenorrhea and other chronic painful diseases; infectious diseases;
2.Extremely severe depression(patient health questionnaire, PHQ-9=20) and other mental disorders
3.Other sleep disorders rather than chronic insomniasuch as sleep apnea,restless leg syndrome;
4.Pregnant or breastfeeding or having the plan to be pregnant;
5.Patients not suitable for moxibustion, such as: allergic constitution,severe dermatosis around the acupoints;
6.Patients who had participated in or were participating in other clinical trials within 3 months prior to enrollment;
7.Patients with a history of alcohol abuse or drug dependence
8.Patients with joint deformity, difficulty in inactivity and unable to lie supine for a long time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index;Pittsburgh Sleep Quality Index;fatigue scale-14;generalized anxiety disorder-7;Actigraphy;Epworth Sleepiness Scale;patient health questionnaire;