Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
NCT02655939 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 258
Last updated 2017-03-28
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Reflex Plus
Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,
- DIETARY_SUPPLEMENT
-
Placebo
Fructose,Orange flavor and sucralose
Sponsors & Collaborators
-
Fullife Healthcare Pvt Ltd
collaborator UNKNOWN -
Vedic Lifesciences Pvt. Ltd.
lead INDUSTRY
Principal Investigators
-
Dr Sachin Dighe, B.A.M.S. · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- India
Study Locations
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