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NCT Number: NCT05540938

Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China-Japan Friendship Hospital

Beijing, 100029, China

Location status: Recruiting

Location contact

Zihan Wang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years.
  • Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
  • Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
  • Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
  • Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
  • Voluntary participation and signed written informed consent.

Exclusion criteria

  • Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
  • Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr <60ml/min) and other important organ function impairment or hematological system diseases.
  • Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
  • Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
  • Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
  • Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).

Treatment and study plan

Wangbi granules

Drug

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.

Wangbi granules simulant

Drug

Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.

Primary outcomes

  1. DAS28

    Time frame: 12 weeks

    Disease mobility score for 28 joints, higher scores indicate higher disease activity

Secondary outcomes

  1. Fatigue Scale-14

    Time frame: 12 weeks

    assessing the patient's fatigue level, the higher the score, the more severe the fatigue

  2. visual analogue scale

    Time frame: 12 weeks

    Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain

Study contacts

Contact information is provided by the study sponsor or research team.

Zihan Wang, Dr

CONTACT

[email protected]

+8618810902100

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • Peking Union Medical College Hospital
  • Southwest Hospital, China
  • The 980th Hospital of PLA Joint Logistics Support Force
  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

Registry information

Official study title

Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 15, 2022
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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