NCT02655939

Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis

Double Blind, Randomized, Multicentre, Placebo Controlled Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Reflex plus™ is a unique blend of Collagen Hydrolysate with Rosehip extract. The blend contains individual ingredients which have been widely studied for its effectiveness in osteoarthritis(OA). Collagen hydrolysate is accumulated in the cartilage and helps to repair the OA, related cartilaginous changes. Rosehip works in the anti-inflammatory pathway thus reducing the pain and inflammation of the joint. The two open-label studies have showed the effectiveness of the investigational product on OA. The 2 studies did not show any specific safety concern to be considered. The study demonstrated the synergistic effect of CH and Rosehip extract from former in-vitro results in the formulation. The supplement has been manufactured in GMP certified manufacturing units in Germany and India under strict quality control check. Hence, quality of the supplement and batch to batch consistency is well assured.

Detailed description

The purpose of this study is to assess the effect of Reflex Plus on osteoarthritis(OA) patients. The duration of the study is 12 / 24 weeks excluding the screening period of approximate 1 week. The test product being studied is Reflex Plus is composed of Collagen hydrolysate and Rosehip extract, it is a health supplement. It is expected to help in the building of cartilage for efficient joint functioning and relieving pain associated with arthritis It helps in cartilage protection and joint pain management.The primary endpoint of the study is the change in knee pain as measured by the WOMAC osteoarthritis (OA) index sum score between baseline and last visit in the comparison between IP and placebo.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Reflex Plus	Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,
DIETARY_SUPPLEMENT	Placebo	Fructose,Orange flavor and sucralose

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-01-14
• Last updated: 2017-03-28

Locations

1 site across 1 country: India