Clinical trial NCT06430307: Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postpartum Rheumatism
Keywords: Saussurea Involucrata Liquid Tonic
Traditional Chinese Medicine
Postpartum Rheumatism
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: VAS (visual analog scale)
timeFrame: 8 weeks
Secondary outcomes:
measure: SF-36
timeFrame: 8 weeks
measure: HADS
timeFrame: 8 weeks
measure: HAQ
timeFrame: 8 weeks
measure: VAS
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: