A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism

Quan Jiang0 sites128 target enrollmentJuly 2024

ConditionsPostpartum Rheumatism

InterventionsSaussurea Involucrata Liquid Tonic

DrugsSaussurea Involucrata Liquid Tonic

Overview

Phase: Phase 4
Intervention: Saussurea Involucrata Liquid Tonic
Conditions: Postpartum Rheumatism
Sponsor: Quan Jiang
Enrollment: 128
Primary Endpoint: VAS (visual analog scale)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Quan Jiang

Responsible Party

Sponsor Investigator

Principal Investigator

Quan Jiang

chief physician

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Arms & Interventions

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.

Intervention: Saussurea Involucrata Liquid Tonic

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.

Intervention: Saussurea Involucrata Liquid Tonic