OmniCreme® was tested in a double blind placebo controlled clinical trial. 64 patients were recruited. 32 patients used creme (active group) 32 used placebo creme. Creme was used twice a day for two weeks.

Joint and muscle pain currently affect affect a large portion of the population. Given the side effects with some conventional drug therapies, a clinical study was undertaken on an OTC topical creme to confirm its efficacy and absence of side effects. The study was planned and executed as per Good Clinical Practices (GCP) laid down by the International Conference on Harmonization (ICH), in order that the data generated may be acceptable to physicians in any of the ICH member country including the USA.

• 51% reduction in pain
• 52% improvement in function
• 53% reduction in fatigue felt after exertion
• 56% reduction in tenderness of the affected area
• 50% improvement in range of motion ( less stiffness)
• No allergic reaction was observed when creme was externally applied on the undamaged skin.
• 69% of active group said they received total or partial relief from their symptoms
• 8% of active group said they received no relief from their symptoms
• 85% of the active group patients said they liked the product

This Phase II randomized controlled trial clearly demonstrates the efficacy, acceptability, tolerability and safety of the OTC “topical pain relief” creme under study. It can be a useful agent in the management of several types of mild to moderate painful conditions such as arthritis, cervical pain, lumbago, tennis elbow, frozen shoulders, sprains, etc. without the use of oral analgesics and anti-inflammatory agents.