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Clinical Study of Qinghao Biejia Decoction Combined with Auricular Acupoint Seed Embedding in Improving TCM Syndromes and Sleep Parameters in Perimenopausal Insomnia Patients

Clinical Observation on the Therapeutic Effect of Qinghao Biejia Decoction Combined with Auricular Acupoint Seed Embedding in Improving Insomnia Symptoms of Liver and Kidney Yin Deficiency Type during Perimenopause

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000037
Enrollment
Unknown
Registered
2026-01-09
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Insomnia during perimenopause

Interventions

Auricular point embedding bean group:Auricular point embedding bean
Traditional Chinese medicine group:Traditional Chinese medicine
Traditional Chinese medicine combined with auricular point embedding bean group:Traditional Chinese medicine combined with auricular point embedding bean

Sponsors

Deqing County Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.It meets the diagnostic criteria of Western medicine. According to the diagnostic criteria for insomnia in the "Classification and Diagnostic Criteria of Mental Disorders in China" issued by the Psychiatry Branch of the Chinese Medical Association: 1) Sleep disorders are almost the only symptom, including light sleep, difficulty falling asleep, frequent dreams and early awakening, difficulty falling back asleep after waking up, or discomfort, fatigue or daytime drowsiness after waking up, etc. 2) Possessing the advantageous concept of insomnia and being extremely concerned about the outcome of insomnia. Dissatisfaction with the quality and quantity of sleep can cause obvious distress or impairment of social functions. 4) It occurs at least three times a week and has been happening for at least one month. 5) Rule out secondary insomnia caused by physical illness or mental disorder symptoms. According to the diagnostic criteria for perimenopause in Obstetrics and Gynecology: 1) For women aged 45 to 55, in addition to menstrual disorders, hot flushes and sweating are typical specific symptoms, which may be accompanied by irritability, palpitations, insomnia, chest tightness, headache, abnormal emotions, memory loss, blood pressure fluctuations, and soreness and pain in the waist and legs. 2) Endocrine tests: Estrone and estradiol levels are decreased, while follicle-stimulating hormone and luteinizing hormone levels are increased. 2. It meets the diagnostic criteria for TCM syndromes. Referring to the content related to "various syndromes before and after menstruation" in the "Twelfth Five-Year Plan" textbook for higher education in the national Traditional Chinese medicine industry published by China Press of Traditional Chinese Medicine, "Gynecology of Traditional Chinese Medicine", and in combination with the diagnostic criteria for insomnia with liver and kidney Yin deficiency in the "Diagnostic and Therapeutic Standards for Diseases and Syndromes in Traditional Chinese Medicine" : Main symptoms: insomnia, hot flushings, sweating, and soreness and weakness of the waist and knees. Secondary symptoms: Irritability, quick temper, dizziness, tinnitus, constipation. Tongue appearance and pulse: The tongue is red with little or thin yellow coating, and the pulse is taut, fine and rapid. 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who have used sex hormone drugs or participated in other clinical trials within the past three months, or those who have used antipsychotic drugs or antidepressants within the three months prior to the study; Patients who have undergone oophorectomy, ovarian tumors, premature ovarian failure, severe liver or kidney insufficiency, or those with serious diseases in other systems, or malignant tumors; People with severe allergic constitutions; Those with severe primary diseases of the liver, kidneys, endocrine system, hematopoietic system, etc. Those with rashes or skin ulcers on the auricle

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index score(PSQI);Changes in TCM syndrome points;

Secondary

MeasureTime frame
Blood routine test, liver and kidney function,urine routine test, stool routine test;Electrocardiogram;Physical examination;

Countries

China

Contacts

Public ContactYing Wu

Deqing County Hospital of Traditional Chinese Medicine

1014315040@qq.com+86 15205822855

Outcome results

None listed

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