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

NCT ID: NCT06430307

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-12-31

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.

Conditions

Postpartum Rheumatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Saussurea Involucrata Liquid Tonic

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

Group Type: EXPERIMENTAL

Saussurea Involucrata Liquid Tonic

Intervention Type: DRUG

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.

placebo of Saussurea Involucrata Liquid Tonic

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.

Group Type: PLACEBO_COMPARATOR

Saussurea Involucrata Liquid Tonic

Intervention Type: DRUG

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.

Interventions

Saussurea 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Quan Jiang

OTHER

Sponsor Role: lead

Responsible Party

Quan Jiang

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2022014P7A01

Identifier Type: -

Identifier Source: org_study_id