Prospective randomized controlled trial of auricular point therapy in the treatment of diabetic patients with anxiety and depressio

Phase 1

Recruiting

• Conditions: Diabetes mellitus combined with anxiety and depression

• Registration Number: ITMCTR2100005415
• Lead Sponsor: Fangshan Hospital Beijing University of 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) meet the diagnostic criteria for type 2 diabetes. (the patient's cognitive and functional status is relatively complete; excluding serious cardiovascular, brain and kidney complications; glycosylated hemoglobin (HbA1c) < 9.0%; the syndrome differentiation of traditional Chinese medicine is liver depression and phlegm obstruction with stasis syndrome: it is mainly characterized by drinking and eating more, thirst and drinking, chest and rib swelling and tightness, accompanied by insomnia, tinnitus, upset and irritable, restlessness, forgetfulness and other symptoms, light tongue, fat tongue, white and greasy fur, twisted sublingual collaterals and stringed veins.)

(2) The evaluation of the scale indicates patients with mild to moderate anxiety and / or depression. (for patients with anxiety or depression with a scale score of 5-19, the course of anxiety and / or depression is less than 5 years)

(3) Age 30-75 years old.

(4) The subjects or their families agreed and signed the informed consent form.

Exclusion Criteria

(1) Ear skin infection and other factors affect the operator of ear point comprehensive therapy.

(2) Complicated with more serious primary diseases of other organs or systems.

(3) Unable to cooperate with the operator of auricular point comprehensive therapy.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Improvement rate of insomnia symptoms;

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose;Blood glucose 2 hours after meal;Traditional Chinese Medicine symptom score;Time within glucose target range;SF-36;HbA1c;PHQ-9;GAD-7;