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

NCT02655939 | Completed Phase 4

• 1 other identifier: FZ/150603/RFX+/OA
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Gonarthrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Reduction in anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 12.

  12 week for protocol A

• Reduction of anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 24.

  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

  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

  24 week for protocol B

• Improvement in structure cartilage of knee joint measured as change in MRI analysis from baseline to Week 24.

  24 weeks for protocol B

Study Arms (2)

Reflex Plus

ACTIVE COMPARATOR

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

Dietary Supplement: Reflex Plus

Placebo

PLACEBO COMPARATOR

Placebo Sachets to be taken once in a day Before breakfast for the study duration

Dietary Supplement: Placebo

Interventions

Reflex Plus DIETARY_SUPPLEMENT

Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,

Reflex Plus

Placebo DIETARY_SUPPLEMENT

Fructose,Orange flavor and sucralose

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead
• Fullife Healthcare Pvt Ltd: collaborator

Study Sites (1)

Mukund Hospital

Mumbai, Maharashtra, 400059, India

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Reflex

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr Sachin Dighe, B.A.M.S.

  sachin.d@vediclifesciences.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: January 14, 2016
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

IN (1)