Evaluation of the effects of supplementation extract prepared from Capparis spinosa on clinical manifestations in patients with refractory rheumatoid arthritis.

Evaluation of the effects of supplementation extract prepared from Capparis spinosa on clinical manifestations, para-clinical and immunological factors in patients with refractory rheumatoid arthritis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151028024760N5

Enrollment

Registered

2022-11-09

Start date

2023-06-22

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Rheumatoid arthritis. Rheumatoid arthritis with rheumatoid factor

Interventions

Intervention 1: Intervention group: Refractory rheumatoid arthritis (RA) patients will be treated by extract prepared from Capparis spinosa (600 mg daily for three months) that will be produced at Pha

Eligibility

Sex/Gender

All

Age

35 Years to 60 Years

Inclusion criteria

Inclusion criteria: Resistant rheumatoid arthritis (RA) patients to non-biological disease-modifying anti-rheumatic drugs (DMARDs) Treated RA patients by non-biological drugs Treated RA patients by Prednisolone, Hydroxychloroquine, Sulfasalazine and Methotrexate Refractory RA patients with no other Rheumatic disorders and inflammatory diseases

Exclusion criteria

Exclusion criteria: Non-resistant RA patients to non-biological disease-modifying anti-rheumatic drugs (DMARDs)

Design outcomes

Primary

Measure	Time frame
Disease activity score 28-joint count-erythrocyte sedimentation rate (DAS28-ESR). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Clinical and laboratory findings.;Visual analog scale (VAS) to assess the level of joint pain. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The amount of pain that a patient feels.	—

Secondary

Measure	Time frame
Rheumatoid factor (RF). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test.;C-reactive protein (CRP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test.;Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) test.;Erythrocyte sedimentation rate (ESR). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Erythrocyte sedimentation rate in millimeters.;Regulatory T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;Th17 cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;CD4+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;CD8+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;FOXP3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;T-bet transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;ROR-gamma T transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;GATA3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy	—

Measure

Time frame

Rheumatoid factor (RF). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test.;C-reactive protein (CRP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test.;Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) test.;Erythrocyte sedimentation rate (ESR). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Erythrocyte sedimentation rate in millimeters.;Regulatory T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;Th17 cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;CD4+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;CD8+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique.;FOXP3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;T-bet transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;ROR-gamma T transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR).;GATA3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDR. Mojgan Mohammadi

Mashhad University of Medical Sciences

Mohammadimzh@mums.ac.ir+98 51 3711 2611

Outcome results

None listed

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