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Based on the"Three-spirit" theory of ear point pressure beans on type 2 diabetes with Yin deficiency effect of sleep disorders

Based on the"Three-spirit" theory of ear point pressure beans on type 2 diabetes with Yin deficiency effect of sleep disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000157
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Type 2 diabetes with sleep disorders

Interventions

Group A Test:The conventional treatment group received education on lifestyle regulation, appropriate physical activity, avoidance of nocturnal mental stimulation, restriction of nighttime fluid intak
Group A Test:Apply ear acupressure seeds to the patient based on routine treatment. Specifically, explain the purpose of the procedure to the patient and strictly follow the standard protocol for ear
Experimental Group B:Based on the conventional auricular acupressure bean application group, the "Three Shen" theory is applied as guidance, with the core treatment concept of sleep regulation being "

Sponsors

Sir Run Run Shaw Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for type 2 diabetes according to the "Guidelines for Prevention and Treatment of Type 2 Diabetes in China" (with a disease duration of more than 3 months), meet the PSQI sleep disturbance assessment criteria (with a disease duration of more than 1 month), and meet the TCM body constitution scale criteria for yin deficiency constitution (symptoms present within 1 month). The criteria are as follows: Diagnostic criteria of Western medicine: Refer to the "Guidelines for Prevention and Treatment of Type 2 Diabetes in China" (2020 edition). The specific diagnostic criteria are as follows: 1) Having typical diabetes symptoms (polydipsia, polyuria, polyphagia, and unexplained weight loss) plus a random venous plasma glucose level of =11.1 mmol/L; or plus 2) Fasting venous plasma glucose =7.0MMOL/L; or plus 3) Venous plasma glucose level is =11.1 mmol/L 2 hours after glucose loading. Diagnostic criteria for sleep disorders: This study adopts the Pittsburgh Sleep Quality Index (PSQI) recommended by the "Diagnostic and Treatment Guidelines for Insomnia Disorders in China" (2017 edition) as the criterion for determining sleep disorders. Diagnostic criteria for TCM constitution: Refer to the "Classification and Determination of TCM Constitution" and the "TCM Constitution Scale" published by the China Association of Traditional Chinese Medicine in 2009, as well as the scoring scale and determination criteria for yin deficiency constitution. 2) Aged 45-75 (inclusive). 3) Generally in good condition and able to cooperate with the test requirements. 4) Volunteer to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who have taken sedative and hypnotic western medicine within one month. 2) Patients with sleep disorders caused by autoimmune system diseases, heart, lung, liver, and kidney organ failure, hematopoietic system diseases, and external factors. 3) Patients with sleep apnea hypopnea syndrome. 4) Vulnerable groups include individuals with mental illnesses, cognitive impairments, critically ill patients, pregnant women, and illiterates.

Design outcomes

Primary

MeasureTime frame
PSQI;Judgment of Yin Deficiency Constitution Improvement;

Secondary

MeasureTime frame
Finger glucose test;Glycated hemoglobin;

Countries

China

Contacts

Public ContactWangting

Sir Run Run Shaw Hospital

15257168604@163.com+86 152 5716 8604

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026