Title
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
Phase
Phase 4Lead Sponsor
Vedic Lifesciences Pvt. Ltd.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
OsteoarthritisIntervention/Treatment
collagen rose hips extract ...Study Participants
258Reflex 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.
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.
Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,
Fructose,Orange flavor and sucralose
Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration
Placebo Sachets to be taken once in a day Before breakfast for the study duration
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.
