A randomized, double-blind, parallel controlled clinical study of tangerine peel enzyme in the treatment of insomnia with deficiency of heart and splee
- Conditions
- insomnia
- Registration Number
- ITMCTR2200005639
- Lead Sponsor
- Guangdong Hospital of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) Over 18 years old.
(2) The diagnosis of chronic insomnia meets the Western medical standard.
(3) It meets the standard of deficiency syndrome of heart and spleen in traditional Chinese medicine.
(4) Pittsburgh sleep quality index (PSQI) total score > 7
(5) Sign informed consent
(1) People who are ready for pregnancy or during pregnancy or lactation or need to sleep with their children.
(2) According to the medical history and consultation, the doctor confirmed the secondary insomnia caused by other diseases.
For example: local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis
(3) Patients with moderate and severe depression (total score = 10) were diagnosed according to the patient's self rating depression tool (PHQ-9)
(4) Patients with moderate and severe anxiety were diagnosed according to GAD-7 (total score = 10)
(5) According to the medical history and consultation, the doctor confirmed that the patient needs to be managed according to the disease management mode.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh sleep index scale total score;
- Secondary Outcome Measures
Name Time Method Patient depression self assessment tool (PHQ-9);Generalized anxiety scale (GAD-7);Insomnia TCM quality of life scale (tcmqli-21);