A double-blind cross-over placebo controlled study of Evogen® Topical gel in the treatment of mild to moderate pain associated with osteoarthritis

Participants: Osteoarthritis of the knees Intervention: Evogen® Topical gel Comparator: Placebo Outcome: Reduction in VAS pain scale scores

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000226404

Acronym

N/A

Enrollment

Registered

2007-04-30

Start date

2007-05-30

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The purpose of the study is to determine the efficacy of Evogen® Topical gel in relieving pain in participants with diagnosed osteoarthritis of the knee. The study hypothesies that the application of Evogen® Topical gel four times a day for 1 week will produce a 50% reduction in pain level.

Interventions

Evogen® Topical gel (nutraceutical) 4 cc to be applied externally to the affected area every 6 hours for 1 week. Placebo dose protocol the same. Participants will use one treatment in the first week of the study, washout for 2 weeks then apply the other treatment for a further 7 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants who are medication free or stable on Glucosamine, NSAID (non steroidal anti inflammatory drugs) or Fish Oil treatment for 3 months.Participants of childbearing age who agree to continue using birth control measures for the duration of the study.

Exclusion criteria

A history of trauma associated with the affected jointRheumatoid or other inflammatory joint conditionsGoutParticipants with a VAS score above 7 at baseline.Participants who have just commenced on a treatment regimen for arthritis Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.

Outcome results