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

Not Applicable

• Conditions: Insomnia

• Registration Number: ITMCTR2000003221
• Lead Sponsor: Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSQI;Constitution scale score;

Secondary Outcome Measures

Name	Time	Method
FS-14;Sleep condition diary;HAS;Sleep data of smart bracelet;