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

Q

Quan Jiang

Status and phase

Begins enrollment this month
Phase 4

Conditions

Postpartum Rheumatism

Treatments

Drug: Saussurea Involucrata Liquid Tonic

Study type

Interventional

Funder types

Other

Identifiers

NCT06430307
2022014P7A01

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

128 participants in 2 patient groups, including a placebo group

Saussurea Involucrata Liquid Tonic
Experimental group
Description:
Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.
Treatment:
Drug: Saussurea Involucrata Liquid Tonic
placebo of Saussurea Involucrata Liquid Tonic
Placebo Comparator group
Description:
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.
Treatment:
Drug: Saussurea Involucrata Liquid Tonic

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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