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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 January 2025
• Main ID: NCT05540938
• Date of registration: 10/09/2022
• Prospective Registration: Yes
• Primary sponsor: China-Japan Friendship Hospital
• Public title: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: May 23, 2023
• Target sample size: 340
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05540938
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Zihan Wang, Dr

• Name: Zihan Wang

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18-75 years.

2. Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.

3. Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and
dampness and stasis blocking channels in Chinese medicine.

4. Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.

5. Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment
and stable treatment regimen for more than 4 weeks.

6. Voluntary participation and signed written informed consent.

Exclusion Criteria:

1. 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).

2. 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.

3. 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.

4. 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.

5. Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or
participating in other clinical trials.

6. Other conditions deemed by the investigator to be inappropriate for trial
participation (out-of-town patients unable to be followed up, etc.).


Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Wangbi granules

Drug: Wangbi granules simulant

Primary Outcome(s)

DAS28 [Time Frame: 12 weeks]

Secondary Outcome(s)

Fatigue Scale-14 [Time Frame: 12 weeks]

visual analogue scale [Time Frame: 12 weeks]

Secondary ID(s)

2022-NHLHCRF-LX-02-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

The 980th Hospital of PLA Joint Logistics Support Force

Southwest Hospital, China

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Peking Union Medical College Hospital