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| Name | Class |
|---|---|
| Fullife Healthcare Pvt Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflex Plus | Active Comparator | Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration |
|
| Placebo | Placebo Comparator | Placebo Sachets to be taken once in a day Before breakfast for the study duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflex Plus | Dietary Supplement | Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g, |
| |
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
Herniated Spinal Disc
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)
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| Name | Affiliation | Role |
|---|---|---|
| Dr Sachin Dighe, B.A.M.S. | sachin.d@vediclifesciences.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mukund Hospital | Mumbai | Maharashtra | 400059 | India |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012018 | Reflex |
| ID | Term |
|---|---|
| D009460 | Neurologic Examination |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Placebo |
| Dietary Supplement |
Fructose,Orange flavor and sucralose |
|
| 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 |
| D010808 | Physical Examination |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |