The study on the acupuncture in treating Insomnia associated with chronic gastritis by the theroy of Tiaodu Hewei: a randmized controlled trial

Phase 1

• Conditions: Insomnia associated with chronic gastritis

• Registration Number: ITMCTR2000003726
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese 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) It conforms to the above diagnostic criteria of western medicine and Chinese medicine for chronic gastritis and insomnia, and insomnia is secondary to chronic gastritis;
(2) The age range is between 18 and 65 years old, without limitation to men or women;
(3) PSQI rating is ok and average;
(4) Duration of insomnia >= 1 month;
(5) Be able to understand the provisions of various daytime functional scales and complete the assessment;
(6) Agree to participate in the investigation and sign written informed consent.

Exclusion Criteria

(1) Patients with severe gastric and/or duodenal ulcers and pathological diagnosis of suspected malignant transformation;
(2) Patients with severe primary or concurrent diseases such as heart, brain, kidney, liver and hematopoietic system;
(3) Patients with systemic diseases such as pain, fever, cough, surgery and secondary insomnia caused by external environmental interference factors;
(4) women who are pregnant, breast-feeding or preparing for pregnancy;
(5) The patient had received other relevant treatments (such as diazepam, alprazolam and other drugs) within the last 2 weeks, which affected the efficacy
The observer;
(6) Patients with severe mental diseases such as schizophrenia;
(7) Participating in other clinical trials.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index, PSQI;

Secondary Outcome Measures

Name	Time	Method
SDS;wActiSleep-BT;Insomnia Severity Index, ISI;PRO;TCM syndrome score scale;