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Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-a and IL-1

Efficacy evaluation of oral formulation of Bene extract in treatment of moderate to severe rheumatoid arthritis and its effect on serum level of inflammatory cytokines TNF-a and IL-1

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201101049223N1
Enrollment
134
Registered
2020-12-21
Start date
2020-12-21
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis. Seropositive rheumatoid arthritis

Interventions

Intervention 1: Intervention group: For 3 months, receive 2 capsules per day of Baneh extract containing 75 mg of luteolin which will be prepared by Mashhad School of Pharmacy. Intervention 2: Control

Sponsors

Gonabad University of Medical Sciences
Lead Sponsor
Gonabad University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 to 65 years Score 6 out of ten ACR / EULAR 2010 criteriaModerate-severe disease according to SDAI criteria (above 11) Patients who continue to have joint pain and swelling despite receiving standard medications (methotrexate, hydroxychloroquine, sulfasalazine, and prednisolone). The type of drug and its dose should be constant for at least 1 month before the study and remain the same during the study. Filling in the written consent

Exclusion criteria

Exclusion criteria: pregnancy and lactation diabetes melitus HF with EF<40% severe infection need IV antibiotics smoking more than 10 cigarette per day

Design outcomes

Primary

MeasureTime frame
Laboratory response. Timepoint: At the beginning of the study and 3 months later. Method of measurement: based on simplified disease activity index (SDAI).;Clinical response to treatment (improved function of joints and morning dryness). Timepoint: At the beginning of the study and 3 months later. Method of measurement: Based on patient interview and clinical examination.;Serum level of ESR, CRP, IL-1, TNF-a. Timepoint: At the beginning of the study and 3 months later. Method of measurement: laboratory exam.

Secondary

MeasureTime frame
Finally the patient is clinically. Timepoint: End of treatment. Method of measurement: Clinical examination and laboratory results.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDavoud Salarbashi

Gonabad University of Medical Sciences

davoud.salarbashi3@gmail.com+98 51 5722 5027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026