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Clinical trial

Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm

ID
Name
2021-SR-015
Description
The purpose of this study is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia .
Trial arms
Trial start
2021-01-22
Estimated PCD
2023-05-30
Trial end
2023-05-30
Status
Completed
Treatment
Suanzaoren Decoction and Huanglian Wendan Decoction
Twice daily. Chinese herbal medicine includes: includes: 25 grams of Suanzaoren, 10 grams of chuanxiong, 30 grams of fushen, 10 grams of Polygala tenuifolia, 10 grams of Pinellia ternata, 12 grams of tangerine peel, 15 grams of Zhuru, 30 grams of forged keel, 30 grams of forged oyster,10 grams of aurantii fructus, 6 grams of coptis chinensis, 30 grams of Albizzia bark.Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient.
Arms:
Chinese medicine group
Other names:
Wild Jujube Seed Decoction and Huanglian Wendan Decoction
Estazolam 1Mg Tab
1mg tablet once daily
Arms:
Western medicine group
Other names:
Estazolam, Estazolam Tablets, Estazolam Pill
Size
187
Primary endpoint
Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks
Baseline and Week 4
Cessation rate of Western medicine hypnotics at Month 6
Month 6
Eligibility criteria
Inclusion Criteria: * Outpatients or inpatients. * It conforms to the chronic insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition). * Chronic insomnia patients with Yin yang imbalance and Ying Wei Disharmony Syndrome. * Informed consent, voluntary participation in the study. Exclusion Criteria: * Sleep apnea syndrome leads to insomnia. * Severe depression, suicidal tendency or having committed suicide. * Pregnant and lactating women. * It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR \> 1.5n (n is the upper limit of normal value), ALT \> 2n (n is the upper limit of normal value), WBC \< 3.0 × 109 / L; * Those who cannot give full informed consent due to mental disorders. * According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment. * Subjects who are participating in other clinical studies.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 187, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

2 products

3 indications

Organization
The First Affiliated Hospital with Nanjing Medical University
Product
Suanzaoren Decoction
Indication
Insomnia
Indication
Circadian Rhythm
Indication
Traditional Chinese Medicine
Product
Estazolam