Effect of Natural Senolytic Agents & NLRP3 Inhibitors on Osteoarthritis
Key facts
- Who runs it
- Assiut University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- People taking part
- 60 people, planned
- Started
- 1 Jul 2022
- Ended
- 1 Dec 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Quercetin and Fisetin tab.
- Quercetin Cap/Tab,Fisetin Cap/tab and Glycyrrhizin capsules
- Placebo
- Record updated
- 25 July 2023
- Why it stopped
- unavailability of drugs
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- male or female, ages 40-80
- Are willing to comply with all study related procedures and assessments
- ambulatory as defined by ability to complete functional performance testing
- Radiographic evidence of Kellgren-Lawrence grade II-IV osteoarthritis in one or both knees
- Scores 4-10 on the Numerical Rating Scale (NRS) for pain
Who cannot take part
- Subjects who are unable to tolerate oral medication
- Surgery on the Study Knee in the past 6 months
- intra-articular injection of corticosteroids or hyaluronic acid in the past 6 months
- Subjects with uncontrolled medical conditions
- subjects with significant liver or renal disease
- Pregnant or nursing females
- Subjects who do not have the capacity to consent themselves
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Objective: To determine the efficacy of natural senolytic agents and NLRP3 Inflammasome inhibitors for reducing knee symptoms and effusion-synovitis in patients with symptomatic knee osteoarthritis and knee effusion-synovitis.
Read full original descriptionShow less
Design: Randomized, double-blind, placebo-controlled trial. Setting: Single-center study with outpatients from university hospital , Faculty of Medicine , Assiut, Egypt .
Participants: 60 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis. Randomized to 3 arms ( natural Senolytic agents alone, natural senolytic plus natural NLRP3 Inflammasome inhibitors and placebo) Intervention: The senolytic agents act by Hit-and-run strategy therefore, intermittent dosing regimens will be applied. 1250 mg/day quercetin + 1000mg/day Fisetin for 3 consecutive days every 3 weeks (n = 20), quercetin + Fisetin for 3 consecutive days followed by 100mg/day glycyrrhizin for one week every 3 weeks (n=20) or matched placebo (n = 20) over 15 weeks Measurements: . The primary outcome measures were change in knee pain (assessed by visual analogue scale VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI). Secondary outcomes are listed as follows: knee pain, function, and stiffness assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), OARSI-OMERACT (Outcome Measures in Rheumatology Clinical trials- Osteoarthritis Research Society International) responders to treatment, cartilage compositional change assessed by cartilage T2 relaxation time (ms), pain medication usage, change in quality of life (Assessment of Quality of Life (AQoL-4D) questionnaire),
The 3 groups in the trial
- (Quercetin +Fisetin)Existing treatment, for comparison
20 participants with symptomatic knee osteoarthritis and ultrasonography defined effusion-synovitis will take natural Senolytic agents. The senolytic agents act by Hit-and-run strategy therefore, intermittent dosing regimens will be applied. 1250 mg/day quercetin + 1000mg/day Fisetin for 3 consecutive days every 3 weeks.over 12 weeks
Treatment: Quercetin and Fisetin tab.
- Quercetin +Fisetin +Glycyrrhizin)Existing treatment, for comparison
20 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis will take Quercetin 1250 mg + Fisetin 1000 mg for 3 consecutive days followed by 100mg/day Glycyrrhizin for one week every 3 weeks over 12 weeks .
Treatment: Quercetin Cap/Tab,Fisetin Cap/tab and Glycyrrhizin capsules
- PlaceboPlacebo, for comparison
Placebo controlled group
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Efficacy of Natural Senolytic Agents and NLRP3 Inhibitors in Treatment of Osteoarthritis: Randomized, Double Blinded ,Placebo Controlled Trial
- Record updated
- 25 July 2023