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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540938
• Other study ID #: 2022-NHLHCRF-LX-02-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 15, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: China-Japan Friendship Hospital
• Contact: Zihan Wang, Dr
• Phone: +8618810902100
• Email: wzhbucm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28	Disease mobility score for 28 joints, higher scores indicate higher disease activity	12 weeks
Secondary	Fatigue Scale-14	assessing the patient's fatigue level, the higher the score, the more severe the fatigue	12 weeks
Secondary	visual analogue scale	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	12 weeks