rheumatoid arthritis with insomnia
Conditions
Interventions
the test group:Shuhe granules, 2 times a day(One hour after breakfast and dinner), 12weeks
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The following criteria must all be met. (1) The research subjects should meet the following diagnostic criteria: ?Patients who meet the ACR/EULAR(2010) diagnostic criteria for RA classification and are in low to moderate disease activity according to DAS28-CRP scoring (2.6=DAS28-CRP=5.1); ?Patients who met the International Classification of Sleep Disorders (ICSD) criteria for insomnia; ? Patients with mild to moderate insomnia according to the insomnia severity index scale (ISI) score (8=ISI=21); (2) Age 18~70 years old, gender is not limited; (3) Written informed consent signed by the subject, family member (guardian) agreeing to participate in this trial;
Exclusion criteria
Exclusion criteria: 1) Patients who diagnosed acute or chronic infectious diseases, including hepatitis B or hepatitis C infection, previous history of cancer and evidence of active, latent, or improperly treated of Mycobacterium tuberculosis infection; (2)Patients who diagnosed with severe depression according to the Depression Self-Assessment Tool (PHQ-9) (total score= 15); (3)Patients who diagnosed with severe anxiety according to the Generalized Anxiety Scale (GAD-7) (total score= 15); (4)Patients who diagnosed with restless legs syndrome and sleep apnea syndrome; (5)Patients who diagnosed severe cardiovascular, brain, lung, liver, kidney, hematopoietic diseases; (6)Patients who are Pregnant, lactating or diagnosed with known mental disorders; (7) Patients with hemoglobin level less than 90 g/L, white blood cell count less than 3.0×109 per liter, or platelet count less than 100×109 per liter; (8) Patients with glomerular filtration rate less than 40ml/min; (9) The level of aspartate aminotransferase or alanine aminotransferase is 1.5 times higher than the upper limit of the normal range (10) Patients with active gastroduodenal ulcer or gastritis caused by long-term use of non-steroidal anti-inflammatory drugs; (11) Patients who are allergic to the experimental drug; (12)Patients enrolled in other clinical trials within 4 weeks before screened;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reaction protein(CRP);Rheumatoid factor(RF);Anti-cyclic citrullinated peptide antibody(CCP);Erythrocyte sedimentation Rate(ESR);Pittsburgh Sleep Quality Index;Fatigue Severiiy Scale;The Patient Health Questionnaire(PHQ-9);Generalized Anxiety Disorder 7(GAD-7); Montreal Cognitive Assessment;Traditional Chinese Medicine Questionnaire of quality of life on insomnia disease;Disease Activity Score 28-joint count (DAS28);The response rate of the ACR definition of improvement(ACR20);28 joint tenderness (TJC28);Health Assessment Questionnaire(HAQ);28-swollen joint count (SJC28);morning stiffness;visual analogue scale; | — |
Countries
China
Contacts
Public ContactZhimin Yang
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Outcome results
None listed