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Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

NCT00253942 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-11-15

No results posted yet for this study

Summary

Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.

Conditions

  • Persons With Mild to Moderate Knee Osteoarthritis

Interventions

PROCEDURE

Injecting bee venom as a treatment for OA

Sponsors & Collaborators

  • Kochan Institute for Healing Arts Research

    collaborator UNKNOWN

  • Rheumatology Therapeutics Medical Center

    lead OTHER

Principal Investigators

  • Boris Ratiner, MD · Medical Director of Rheumatology Therapeutics Medical Center

  • Andrew Kochan, MD · Medical Director of Kochan Institute for Healing Arts Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00253942 on ClinicalTrials.gov