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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Reflex Plus
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male and Female, aged ≥ 50 yrs and ≤ 70 yrs, with BMI<30. WOMAC pain score, between 8-16 on a scale of 0 to 20. Diagnosis confirmed of Gonarthrosis, by clinical and radiological means by Jaeger-Wirth score ≥2. Females to be included in the study should have reached menopause. Subjects willing to stop the restricted supplements and medications prior to inclusion in study and even during the study. Subjects using topical applications and rescue medication willing to stop the use 48 hours prior to all assessment. Subjects with Fasting blood glucose level ≤ 140 and Systolic blood pressure ≤ 160 mm of Hg and diastolic blood pressure ≤ 100 mm of hg. Subjects willing to adhere to protocol and complete subject diary. Patient willing and able to provide signed informed consent. Exclusion Criteria Knee pain or functional impairment of the knee joint from causes other than osteoarthritis. Peripheral arterial occlusive disease Acute meniscus injuries Rheumatoid Arthritis Infection-associated arthritis Coxarthrosis Bony injuries of lower extremities(e.g. femoral neck fracture) in the last 12 months Herniated Spinal Disc Any other severe organic and/or systemic diseases (e.g. renal, hepatic, cardiovascular) as per investigator's discretion Known allergies and/or sensitivities to ingredients of Reflex Plus™ or rescue medication Regular intake of products that may influence the study outcome, e.g.: Nutritional Supplement such as vitamin supplements Mineral products, protein, amino acid concentrates Chondroprotective agents such as glucosamine sulfate, chondroitin sulfate, gelatin, hyaluronic acid and methylsulfonylmethane. Fish oil capsules (omega 3 fatty acid capsules) Treatment with cartilage protection products in the last 3 months. Treatment (oral ingestion and injection) with steroidal and non-steroidal anti-inflammatory drugs with an exception of the following short-acting NSAID: acetylsalicylic acid, diclofenac, ibuprofen, celecoxib; other analgesics e.g. paracetamol, metamizole and phenazone. Cortisone treatment within less than 3 weeks prior to study inclusion. Intake of Opioid analgesics. Intake of anticoagulants of the coumarin type, such as acenocoumarol and phenprocoumon. Simultaneous treatment of osteoarthritis of knee with magnetic therapy, shockwave therapy, acupuncture Smokers will be excluded from the study. Occasional smokers willing to abstain smoking during the study can be considered. History of drug and alcohol abuse. Simultaneous participation in another clinical trial or participation in such within the last 6 weeks.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reflex Plus<br>Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration | Dietary Supplement: Reflex Plus<br>* Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,<br>|
| Placebo Comparator: Placebo<br>Placebo Sachets to be taken once in a day Before breakfast for the study duration | Dietary Supplement: Placebo<br>* Fructose,Orange flavor and sucralose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction from baseline in total score of WOMAC osteoarthritis index at Week 12. | 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. | 12 week for protocol A | 
| Reduction from baseline in total score of WOMAC osteoarthritis index at Week 24. | 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. | 24 week for protocol B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 12. | 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. | 12 week for protocol A | 
| Reduction of anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 24. | 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. | 24 week for protocol B | 
| 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 | 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 | 12 week for protocol A | 
| 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 | 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 | 24 week for protocol B | 
| Improvement in structure cartilage of knee joint measured as change in MRI analysis from baseline to Week 24. | To study the effect of Reflex Plus™ on structure of knee joint measured as change in MRI analysis from baseline to Week 24. | 24 weeks for protocol B | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonarthrosis