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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005415
Enrollment
Unknown
Registered
2021-12-17
Start date
2021-04-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus combined with anxiety and depression

Interventions

Treatment group:Basic therapy combined with auricular point comprehensive therapy

Sponsors

Fangshan Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Improvement rate of insomnia symptoms;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactHong Zhang
hong_xueming@sina.com13911721600

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026