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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Rheumatism
• Intervention / Treatment: Drug: Saussurea Involucrata Liquid Tonic

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Visual Analogue Score	8 weeks
SF-36	the MOS item short from health survey, SF-36	8 weeks
HADS	Hospital Anxiety and Depression Scale	8 weeks
HAQ	Stanford Health Assessment Questionnaire	8 weeks

Collaborators and Investigators

• Sponsor: Quan Jiang

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Saussurea Involucrata Liquid Tonic; Postpartum Rheumatism
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 2022014P7A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No