Efficacy and Safety of Saussurea Involucrata Liquid Tonic in Patient With Postpartum Rheumatism

Quan Jiang

Status and phase: Not yet enrolling; Phase 4

Conditions: Postpartum Rheumatism

Treatments: Drug: Saussurea Involucrata Liquid Tonic

Study type: Interventional

Funder types: Other

Identifiers

NCT06430307

2022014P7A01

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Saussurea Involucrata Liquid Tonic

Experimental group

Description:

Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.

Treatment:

Drug: Saussurea Involucrata Liquid Tonic

placebo of Saussurea Involucrata Liquid Tonic

Placebo Comparator group

Description:

placebo of Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.

Treatment:

Drug: Saussurea Involucrata Liquid Tonic