Effect of ß-Caryophyllene on Multiple Sclerosis

Evaluation of the safety and effectiveness of ß-Caryophyllene on clinical symptoms of Multiple Sclerosis patients: a double-blind and placebo-controlled clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180103038199N19

Enrollment

120

Registered

2025-06-19

Start date

2025-08-23

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group 1: Patients with multiple sclerosis receiving one 30 mg capsule containing beta-caryophyllene and 220 mg Avicel (prepared at Mashhad University of Medical Sciences)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with MS based on common diagnostic criteria. Having at least one attack in the last two years EDSS motor disability score between 3.5 and 6.5 Age between 18 and 55 years old

Exclusion criteria

Exclusion criteria: History of alcohol or drug addiction History of pregnancy or breastfeeding in the last 12 months Kidney dysfunction eGFR below 30 Liver dysfunction with more than a two-fold increase in liver enzymes Treatment with steroids during the last 2 months before the start of the study Having a neurological disease in addition to MS Uncontrolled hypertension Having infectious disease (Including respiratory and urinary tract infections) Having a history of severe respiratory or skin sensitivity

Design outcomes

Primary

Measure	Time frame
Change in disease symptoms based on EDSS. Timepoint: At the beginning of the study, 1 month and 3 months later. Method of measurement: Checklist.	—

Secondary

Measure	Time frame
Average time to onset of first attack. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Checklist.;Average number of attacks. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Checklist.;Complete Blood Count with Differential. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Hematology Analyzer.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Alanine Transaminase. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Aspartate Transaminase. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Urea. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Creatinine. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.	—

Measure

Time frame

Average time to onset of first attack. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Checklist.;Average number of attacks. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Checklist.;Complete Blood Count with Differential. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Hematology Analyzer.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Alanine Transaminase. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Aspartate Transaminase. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Urea. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.;Creatinine. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Laboratory kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Reza Askari

Mashhad University of Medical Sciences

askariv@mums.ac.ir+98 51 3800 2264

Outcome results

None listed

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