ITMCTR2000003357
Not yet recruiting
Phase 1
The clinical efficacy research and Intestinal flora of Wu-Mei-Wan Decoction in treatment of early awakening insomnia
inyi City People's Hospital0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- inyi City People's Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) in line with the western medicine diagnostic criteria for insomnia
- •(2\) in accordance with the clinical manifestations of early awakening: sleep awakening time than normal time above 30 min in advance, or wake up earlier than usual 1 \~ 2 h, the total sleep time is less than 6 h; Includes the following 1 to several items: extremities cold, apex pain, thirst, hunger, restlessness and restlessness.
- •(3\) the total PSQI score was \> and 7;
- •(4\) between the ages of 18 and 60, both male and female;
- •(5\) to understand the clinical observation significance of this drug, actively cooperate with the clinical follow\-up and clinical evaluation of the researchers engaged in this drug, and have good compliance;
- •(6\) patients voluntarily participate in this study with full knowledge;
- •(7\) drugs that damage liver and kidney functions have not been applied within 3 months;
- •(8\) denied participating in other treatments within 3 months;
- •(9\) have not taken any sedatives within one week;
- •(10\) those who are conscious, agree and able to cooperate in collecting clinical data.
Exclusion Criteria
- •(1\) patients with insomnia who complained of multiple dreams and impaired shallow social function;
- •(2\) excluding secondary insomnia: insomnia caused by systemic diseases such as pain, fever, cough, surgery, external interference, etc., as well as insomnia caused by physical diseases or mental disorders, such as depression; Anxiety disorder; People with mental illness;
- •(3\) patients with serious primary and serious organic diseases including heart, cerebrovascular, lung, liver, kidney and hematopoietic system;
- •(4\) patients with allergic constitution;
- •(5\) women during pregnancy and lactation;
- •(6\) patients with alcohol and drug dependence and substance abuse;
- •(7\) patients with decompensated respiratory dysfunction, myasthenia gravis and severe sleep apnea.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Evaluation of clinical efficiency of intestinal tract blood flow measurement using the ICG fluorescence method in a colorectal cancer surgeryJPRN-UMIN000012432Juntendo University Faculty of Medicine20
Not yet recruiting
Not Applicable
Comparison of Efficacy of SRP Alone & in Combination with LDD & Mouthwash in patients with PeriodontitisCTRI/2023/07/055061SGT UNIVERSITY
Not yet recruiting
Phase 1
Investigating the clinical efficacy and mechanism of Runfei Huayu recipe in treating connective tissue disease merger interstitial lung disease based on Th17/Treg glycolytic pathwayITMCTR2200006523Taizhou Hospital of traditional Chinese Medicine
Completed
Not Applicable
Confirmation study about effects on intestinal microbiota and safety of dietary fiber mixture powder intake in healthy subjectsJPRN-UMIN000041199CPCC Company Limited60
Not yet recruiting
Not Applicable
A clinical trial to evaluate to GastroIntestinal protective eFfect of Tegoprazan for utilization of potent P2Y12 inhibitors in patients with Acute Coronary Syndrome (GIFT-ACS trial)Diseases of the circulatory systemKCT0007897Yonsei University Yongin Severance Hospital124