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The clinical efficacy research and Intestinal flora of Wu-Mei-Wan Decoction in treatment of early awakening insomnia

The clinical efficacy research and Intestinal flora of Wu-Mei-Wan Decoction in treatment of early awakening insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033404
Enrollment
Unknown
Registered
2020-05-31
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

early awakening insomnia

Interventions

Sponsors

Linyi City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
intestinal flora;PSQI;Quality of life scale of traditional Chinese Medicine;

Countries

China

Contacts

Public ContactZhu xiaosong

Linyi City People's Hospital

zxs_sdu@163.com+86 15106677973

Outcome results

None listed

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