Postpartum Rheumatism
Conditions
Keywords
Saussurea Involucrata Liquid Tonic, Traditional Chinese Medicine, Postpartum Rheumatism
Brief summary
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism.
Interventions
DRUGSaussurea Involucrata Liquid Tonic
This product is a single preparation of Saussurea Involucrata Liquid Tonic. It is used for rheumatoid arthritis, rheumatoid arthritis and dysmenorrhea caused by insufficient kidney yang and cold-damp stasis.
Sponsors
Quan Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations * Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome. * Age 18-50 * Pain VAS score ≥4cm
Exclusion criteria
* Those in the puerperium (within 42 days after delivery). * Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy. * Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count \< 3.0×109/L, or hemoglobin \< 90 g/L, or platelet count \< 100.0×109/L in routine blood examination * Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc. * Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks. * Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution. * Existing or past history of cancer. * Those who have participated in other clinical drug studies in the past 2 months. * Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS (visual analog scale) | 8 weeks | The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | 8 weeks | the MOS item short from health survey, SF-36 |
| HADS | 8 weeks | Hospital Anxiety and Depression Scale |
| HAQ | 8 weeks | Stanford Health Assessment Questionnaire |
| VAS | 8 weeks | Visual Analogue Score |
Outcome results
None listed