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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Reflex Plus

• Registration Number: NCT02655939
• Lead Sponsor: Vedic Lifesciences Pvt. Ltd.

Brief 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-14
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Sachets to be taken once in a day Before breakfast for the study duration
Reflex Plus	Reflex Plus	Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration

Primary Outcome Measures

Name	Time	Method
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 24.	24 week for protocol B	To study the change in WOMAC index score from Baseline to Week 24 with respect to: Pain, Stiffness, Physical Function .Total WOMAC score 27 we expect a decrease from baseline WOMAC score in the subjects with knee joint pain.
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 12.	12 week for protocol A	To study the change in WOMAC index score from Baseline to Week 12 with respect to: Pain, Stiffness, Physical Function .Total WOMAC score 27 we expect a decrease from baseline WOMAC score in the subjects with knee joint pain.

Secondary Outcome Measures

Name	Time	Method
Improvement in structure cartilage of knee joint measured as change in MRI analysis from baseline to Week 24.	24 weeks for protocol B	To study the effect of Reflex Plus™ on structure of knee joint measured as change in MRI analysis from baseline to Week 24.
Reduction of anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 24.	24 week for protocol B	To study the change on anti-inflammatory markers, Serum C reactive protein (CRP) measured from baseline to Week 24.; C- reactive protein Normal Range is \< 5.0 mg/dl which is expected to be raised in subjects with Osteoarthritis.
Increase in joint flexibility measured as change from baseline in axis and range of motion as assess by goniometry at Week 12.baseline in axis and range of motion as assess by goniometry at Week 24	24 week for protocol B	To study the change on joint flexibility measured as change from baseline by goniometry to Week 24.; Joint Inspection Joint Palpation,Impaired Movement,Axis of Joint,Range of Motion To study the change in MRI for index joint as change from baseline to Week 24.we expect change in range of motion as assessed by goniometry Joint Inspection Joint Palpation,Impaired Movement,Axis of Joint,Range of Motion To study the change in MRI for index joint as change from baseline to Week 24.we expect change in range of motion as assesed by goinometry
Reduction in anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 12.	12 week for protocol A	To study the change on anti-inflammatory markers, Serum C reactive protein (CRP) measured from baseline to Week 12.; C- reactive protein Normal Range is \< 5.0 mg/dl which is expected to be raised in subjects with Osteoarthritis.
Increase in joint flexibility measured as change from baseline in axis and range of motion as assess by goniometry at Week 12.baseline in axis and range of motion as assess by goniometry at Week 12	12 week for protocol A	To study the change on joint flexibility measured as change from baseline by goniometry to Week 12.; Joint Inspection Joint Palpation,Impaired Movement,Axis of Joint,Range of Motion We expect change in range of motion as assessed by goniometry

Trial Locations

Locations (1)

Mukund Hospital; 🇮🇳 Mumbai, Maharashtra, India