Effects of aqueous extract of black barberry fruit on active rheumatoid arthritis Patients

Effects of aqueous extract of black barberry fruit on clinical signs, some inflammatory factors, glycemic profile, lipid Profile, blood pressure, and percent of body fat in active rheumatoid arthritis patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201409249472N7

Enrollment

Registered

2015-01-18

Start date

2015-03-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Active rheumathoid arthritis. Other specified rheumatoid arthritis

Interventions

Intervention 1: Taking aqueous extract of black barberry supplement, 2000 miligram (2* 1000 milligrams capsules aqueous extract of black barberry per day for 3 months (12 weeks). Intervention 2: Takin

Placebo

Taking aqueous extract of black barberry supplement, 2000 miligram (2* 1000 milligrams capsules aqueous extract of black barberry per day for 3 months (12 weeks)

Taking placebo, 2000 miligram (2* 1000 milligrams capsules) maltodextrin per day for 3 months (12 weeks).

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: person with RA disease as American College of Rheumatology (ACR) criteria; age between 20-69 years; having RA from 1 years ago; active rheumatoid arthritis; acceptance of patient; not having diabetes mellitus, hypertension, thyroid problem, renal failure and liver dysfunction; not smoking; not being pregnant or lactated; not receiving omega-3 or antioxidants supplements from 3 month ago; not getting contraceptive drugs; exclusion criteria: reluctance for continuing the cooperation ; taking less than 80% of supplements given to patients at baseline (the compliance lower than %80); sudden strickening to an acute disease; migration ; any change in drug and treatment protocol that can cause omission from study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: First day and three months later. Method of measurement: visual analogue scales.;Morning stiffness. Timepoint: First day and three months later. Method of measurement: Examintion.;Number of inflammated joints. Timepoint: First day and three months later. Method of measurement: Examintion.;DAS28. Timepoint: First day and three months later. Method of measurement: Examintion.;Hs-CRP. Timepoint: First day and three months later. Method of measurement: elisa.;TNF a. Timepoint: First day and three months later. Method of measurement: Elisa.;ESR. Timepoint: First day and three months later. Method of measurement: Westergren.;FBS. Timepoint: First day and three months later. Method of measurement: GOD/POD.;TC. Timepoint: First day and three months later. Method of measurement: Enzymatic.;TG. Timepoint: First day and three months later. Method of measurement: Enzymatic.;LDL. Timepoint: First day and three months later. Method of measurement: Formula.;HDL. Timepoint: First day and three months later. Method of measurement: Enzymatic.;Systolic and diastolic blood pressure. Timepoint: First day and three months later. Method of measurement: Mercuyi barometer.;Body fat percent. Timepoint: First day and three months later. Method of measurement: BIA.	—

Measure

Time frame

Pain. Timepoint: First day and three months later. Method of measurement: visual analogue scales.;Morning stiffness. Timepoint: First day and three months later. Method of measurement: Examintion.;Number of inflammated joints. Timepoint: First day and three months later. Method of measurement: Examintion.;DAS28. Timepoint: First day and three months later. Method of measurement: Examintion.;Hs-CRP. Timepoint: First day and three months later. Method of measurement: elisa.;TNF a. Timepoint: First day and three months later. Method of measurement: Elisa.;ESR. Timepoint: First day and three months later. Method of measurement: Westergren.;FBS. Timepoint: First day and three months later. Method of measurement: GOD/POD.;TC. Timepoint: First day and three months later. Method of measurement: Enzymatic.;TG. Timepoint: First day and three months later. Method of measurement: Enzymatic.;LDL. Timepoint: First day and three months later. Method of measurement: Formula.;HDL. Timepoint: First day and three months later. Method of measurement: Enzymatic.;Systolic and diastolic blood pressure. Timepoint: First day and three months later. Method of measurement: Mercuyi barometer.;Body fat percent. Timepoint: First day and three months later. Method of measurement: BIA.

—

Secondary

Measure	Time frame
Body mass index. Timepoint: First day and three months later. Method of measurement: Calculation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Naheed Aryaeian

Iran University of Medical Sciences

n-aryaeian@sina.tums.ac.ir+98 21 8877 9118

Outcome results

None listed

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