ankylosing spondylitis
Conditions
Interventions
Treatment group :Bushen Qiangdu Sanhan granule
Placebo group:placebo
Sponsors
ShangHai GuangHua Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following requirements to be considered for study enrollment: (1) age=18 years (2) defined ankylosing spondylitis according to the New York criteria revised in 1984. (3) meet the criteria of stagnation of asthenia kidney and cold-syndrome in du-channel in Dalv.(Referring to Practical Traditional Chinese Medicine College of Rheumatology (2nd edition) (edited by Wang Chengde and published by Peoples Medical Publishing House in 2009). Primary symptoms: ?lumbosacral pain, back pain, ?limited lumbar spinal movement, ?fears the cold and prefers warmth, or cold pain in joint, ?morning stiffness. Secondary symptoms: ?soreness and weakness of waist and knees, ?fatigue and weakness, ?absence of thirst or thirst without desire to drink, ?creeping chill of scrotum or excessive thin clear leukorrhea, ?shapeless stools, or frequent urination at night. Tongue veins: dark red tongue, white thin or white thick, deep and taut pulse or with fine pulse. The diagnosis is confirmed with all the main symptoms, or =3 secondary symptoms, and the tongue and pulse are generally consistent. (4)low to moderate disease activity: Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)=1.3 and <3.5. (5)in reproductive age, female patient or male patient's spouse needs to have a negative pregnancy test. (6)understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if any of the following are met. (1)complication causing musculoskeletal disorders other than AS (i.e., rheumatoid arthritis, reactive arthritis, psoriatic arthritis, systemic scleroderma, inflammatory myopathy, or mixed connective tissue disease); (2)treated with NSAIDs within 2 weeks prior to enrolment (3)treated with a biologic DMARD or a biosimilar DMARD (i.e., etanercept or biosimilar of etanercept) within 12 weeks before randomisation (5)treated with DMARDs (i.e.,sulfasalazine thalidomide or methotrexate) within 4 weeks before randomisation (6)ready to have a baby in within 6 months. (7)current pregnancy, breastfeeding (8)Those with serious diseases such as heart, brain, lung, liver, kidney, tumor, infection or hematopoietic system. (9)peripheral blood leukocytes or neutrophils below the lower limit of normal. (10)abnormal liver function with AST or ALT levels above the upper limit of normal (11)abnormal kidney function with Cr above the upper limit of normal (12)history of substance abuse or alcoholism or mental illness (13)allergy to the ingredients of the study drug (including excipients). (14)inappropriateness for study inclusion as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP);Traditional Chinese Medicine Syndrome Score Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bath Ankylosing Spondylitis Functional Index (BASFI);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Metrology Index (BASMI);erythrocyte sedimentation rate (ESR);C-reactiveprotein (CRP); | — |
Countries
China
Contacts
Public ContactCheng Peng
ShangHai GuangHua Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed