ITMCTR2200006603
Not yet recruiting
Phase 2
A randomized, double-blind, controlled clinical trial of Suhe Granules for chronic insomnia patients with Disharmony of Qi and Blood and Deficiency of Heart and Kidney
Guangdong Provincial Hospitai of Chinese Medicine0 sitesTBD
Conditionsinsomnia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- insomnia
- Sponsor
- Guangdong Provincial Hospitai of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) 18 years old or older;
- •(2\) Meet the diagnostic criteria for chronic insomnia of International Classification of Diseases\-11(ICD\-11\);
- •(3\) Meet the diagnostic criteria of Shuhe Granules:
- •Cold or wind intolerance, daytime mental fatigue, palpitations or dizziness, pale lower eyelids or red at the edge of lower eyelids, low menstrual flow and cold hands;
- •(4\) Signed the informed consent form;
Exclusion Criteria
- •(1\) Meet any criteria of the eliminating symptoms
- •eliminating symptoms:
- •a. The lower eyelid is completely red
- •b. Hand baking heat
- •c. The stool is dry and(or) hard
- •d. The moss is thick or dry and rough
- •e. The pulse\-to\-breath ratio is greater than 5
- •(2\) People who are preparing to become pregnant or pregnant or breastfeeding, or who need to accompany their children to sleep;
- •(3\) According to the medical history and consultation, the doctor confirms that 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, etc.;
- •(4\) Diagnosis of severe depression patients according to the Patient Health Questionnaire\-9 (PHQ\-9\)(total score \=15\);
Outcomes
Primary Outcomes
Not specified
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