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

Phase 2

• Conditions: insomnia

• Registration Number: ITMCTR2200006603
• Lead Sponsor: Guangdong Provincial Hospitai 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) 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);
(5) Diagnosis of patients with severe anxiety according to the Generalised anxiety disorder-7(GAD-7)(total score =15);
(6) Those who have participated in clinical trials of other drugs in the past 30 days;
(7) Patients with other mental illnesses

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
The total score of Fatigue Scale-14(FS-14);The total scores and the various scores of the Pittsburgh sleep quality index;The total score of the Patient Health Questionnaire-9 (PHQ-9);The total score of the Sleep Diary;The total score of the Generalised anxiety disorder-7(GAD-7);