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Bee Venom for Knee Osteoarthritis

Phase 3

Waitlist Available

Led By Boris Ratiner, MD

Research Sponsored by Rheumatology Therapeutics Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Morning stiffness less than 30 minutes duration

On a stable dose of medication or none at all due to intolerance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether bee venom can relieve pain for people with mild to moderate osteoarthritis. 40 people will be in the study, with 30 getting bee venom and 10 getting histamine as a control. Each person will get 14 injections over 18 weeks. The study will track whether the bee venom group has less pain and discomfort, improved function, and so on.

Who is the study for?

This trial is for people over 35 with mild to moderate knee osteoarthritis who can manage pain with only Acetaminophen. Participants must not have severe arthritis pain, inflammatory conditions like RA, recent invasive knee procedures, or allergies to bee venom or Lidocaine. They should be able to walk and climb stairs without significant issues.Check my eligibility

What is being tested?

The study tests if injectable bee venom can safely reduce pain and improve function in knee osteoarthritis patients compared to histamine control. Subjects will receive multiple injections over 18 weeks, aiming for long-term benefits beyond the treatment period.See study design

What are the potential side effects?

Expected side effects of bee venom include redness and itchiness at the injection site but are anticipated to be minor and tolerable for those not allergic to it. Histamine may cause similar reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My morning stiffness lasts less than 30 minutes.

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I am on a steady dose of medication or not taking any due to side effects.

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My pain level is between 4 and 8 when I walk.

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I have been diagnosed with osteoarthritis in one knee.

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I can manage my pain with only Acetaminophen for the study duration.

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I am older than 35 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 50 ft. walk and 4 step up/down climb time

Change in Knee Injury and Osteoarthritis Outcome Score

Change in Visual Analog Scale

+1 more

Secondary outcome measures

Adverse event incidence

Baseline and visit 12 laboratory assessments

Change in tenderness and motion

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rheumatology Therapeutics Medical CenterLead Sponsor

Kochan Institute for Healing Arts ResearchUNKNOWN

Boris Ratiner, MDPrincipal InvestigatorMedical Director of Rheumatology Therapeutics Medical Center

Media Library

Bee Venom (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00253942 — Phase 3

Knee Osteoarthritis Research Study Groups:

Knee Osteoarthritis Clinical Trial 2023: Bee Venom Highlights & Side Effects. Trial Name: NCT00253942 — Phase 3

Bee Venom (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00253942 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial consider patients who are octogenarians?

"This study is only recruiting patients aged 35 or younger. Out of the 688 clinical trials that are searching for patients outside this age group, 38 trials are looking for people under 18."

Answered by AI

Is this drug protocol cleared by the FDA?

"This trial is a Phase 3, which means that while there is some evidence of the treatment's efficacy, there is also multiple rounds of data supporting safety."

Answered by AI