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Active and passive intervention conbined with characteristic treatment regimens of traditional Chinese medicine in insomnia: A multicentre, randomized, double-blind, placebo-controlled trial

Research on health state intervention by active and passive ways and management techniques based on the combination of traditional Chinese medicine constitution (subtopic 3) : clinical evaluation of intervention techniques for subthreshold depression, insomnia and mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032041
Enrollment
Unknown
Registered
2020-04-18
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Insomnia

Interventions

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of insomnia in western medicine; The following conditions are met: (1) One or more of the following phenomena observed by the patient or his parents or caregivers: Difficulty in falling asleep; Difficulty in sleep maintenance; The awakening time is earlier than expected; Refuse to go to sleep till the time of sleeping; It is difficult to sleep without parents or caregivers; (2) One or more of the following phenomena related to nocturnal sleep difficulties observed by the patient's chief complaint or his parents or caregivers: Fatigue or malaise; Decreased attention, concentration or memory; Social, family, professional or learning decline; Emotional instability or irritability; Daytime sleepiness; Behavioral problems, such as overactive, impulsive, or aggressive; The decrease of magic power, energy or work initiative; Easy to make mistakes or accidents; Very concerned or dissatisfied with their sleep quality. (3) There are still complaints of sleep wakefulness difficulty with sufficient sleep time, opportunity and suitable sleep environment; (4) The above-mentioned sleep difficulties and related daytime symptoms occur at least 3 times a week; (5) The above sleep difficulties and related daytime symptoms lasted at least 3 months; (6) These sleep difficulties and related daytime symptoms cannot be better explained by other sleep disorders. 2. Patients between 18 and 59 years old; 3. Patients with conscious, clear and available language communication; 4. Patients without olfactory disturbance; 5. Patients with Pittsburgh sleep quality index > 5; 6. Patients who have not used sleeping drugs or have stopped using sleeping drugs for more than one month; 7. Patients who understand and can cooperate with the corresponding trial scheme and are willing to sign the informed consent; Those who meet all the above conditions are included in the study.

Exclusion criteria

Exclusion criteria: 1. All patients with general diseases such as pain, fever, cough, operation, etc., as well as external environmental interference factors causing insomnia; 2. The patients with anxiety or depression, or the patients with serious mental diseases that affect sleep, such as the patients with severe mental diseases; 3. Pregnancy, lactation and objects with pregnancy plan; 4. Patients who are allergic to aromatic drugs or have a history of serious adverse reactions and severe allergic constitution; 5. Patients with other serious circulatory system, hematopoietic system, digestive system, endocrine system and other diseases; 6. Patients who are participating in clinical trials of other drugs. Those who meet any of the above conditions are excluded from this study.

Design outcomes

Primary

MeasureTime frame
PSQI;Constitution scale score;

Secondary

MeasureTime frame
HAS;FS-14;Sleep data of smart bracelet;Sleep condition diary;

Countries

China

Contacts

Public ContactHan Zhenyun

Beijing University of Chinese Medicine

tohanzhenyun@sina.com+86 13581647676

Outcome results

None listed

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