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

Phase 4

Not yet recruiting

• Conditions: Postpartum Rheumatism
• Interventions: Drug: Saussurea Involucrata Liquid Tonic

• Registration Number: NCT06430307
• Lead Sponsor: Quan Jiang

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Study Start: 2024-07
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saussurea Involucrata Liquid Tonic	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.
placebo of Saussurea Involucrata Liquid Tonic	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.

Primary Outcome Measures

Name	Time	Method
VAS (visual analog scale)	8 weeks	The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.

Secondary Outcome Measures

Name	Time	Method
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