A single-center, double-blind, randomized, placebo-controlled clinical study of Shuhe granule in the treatment of chronic insomnia with qi-blood disharmony and deficiency of both heart and kidney
- Conditions
- insomnia
- Registration Number
- ITMCTR2024000035
- Lead Sponsor
- Guangdong Provincial Hospitai of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) 18 to 65 years of age.
(2) meet the diagnostic criteria of chronic insomnia in western medicine.
(3) meet the diagnostic criteria of insomnia in traditional Chinese medicine.
(4) consistent with the syndrome of disharmony between qi and blood and deficiency of both heart and kidney.
(5) sign the informed consent form.
(1) comply with any one of the excluded symptoms.
a. The lower eyelid is all red.
b. The hands are hot.
c. Stool dry knot, hard.
d. Thick, greasy or dry rough moss.
e. The pulse-to-interest ratio is greater than 5.
(2) people who are preparing for pregnancy or pregnancy or lactation or who need to accompany their children to sleep.
(3) according to medical history and consultation, doctors confirm secondary insomnia caused by other diseases. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.
(4) patients with severe depression were diagnosed according to the depression screening tool (PHQ-9) (total score = 15).
(5) patients with severe anxiety were diagnosed according to the generalized anxiety disorder scale (GAD-7) (total score = 15).
(6) patients with severe insomnia according to insomnia severity index (ISI) (total score = 22).
(7) those who have participated in clinical trials of other drugs in the past 30 days.
(8) complicated with other mental disorders.
(9) the hemoglobin level is less than 90g/L, the white blood cell count is less than 3.0 × 10 ^ 9 / L, or the platelet count is less than 100 × 10 ^ 9 / L.
(10) patients whose glomerular filtration rate is lower than that of 40ml/min.
(11) Aspartate aminotransferase or alanine aminotransferase was 1.5 times higher than the upper limit of the normal range.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The total socres of Insomnia Severity Index (ISI);
- Secondary Outcome Measures
Name Time Method Syndrome score of traditional Chinese medicine;Generalized anxiety Disorder scale (GAD-7);Visual analogue fatigue score (VFAS);The total scores and the various scores of the Pittsburgh sleep quality index;Syndrome score of traditional Chinese medicine;Patient Health Questionnaire(PHQ-9);Fatigue severity scale (FSS);