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

NCT06430307 | Not Yet Recruiting Phase 4

• 1 other identifier: 2022014P7A01
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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

Keywords

Saussurea Involucrata Liquid Tonic; Traditional Chinese Medicine; Postpartum Rheumatism

Outcome Measures

Primary Outcomes (1)

• VAS (visual analog scale)

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

  8 weeks

Secondary Outcomes (4)

• SF-36

  8 weeks

• HADS

  8 weeks

• HAQ

  8 weeks

• VAS

  8 weeks

Study Arms (2)

Saussurea Involucrata Liquid Tonic

EXPERIMENTAL

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

placebo of Saussurea Involucrata Liquid Tonic

PLACEBO COMPARATOR

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

Interventions

Saussurea Involucrata Liquid Tonic 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.

Saussurea Involucrata Liquid Tonic; placebo of Saussurea Involucrata Liquid Tonic

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quan Jiang: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share