OsteoarthritisPhase 4NCT02655939
Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
A Phase 4 study testing Reflex Plus in people with Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Reflex Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomized, Multicentre, Placebo Controlled Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Reflex Plus, Placebo
- Keywords
- Gonarthrosis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex PlusDietary supplement
Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,
PlaceboDietary supplement
Fructose,Orange flavor and sucralose
| Study group | Role | What they receive |
|---|---|---|
| Reflex Plus | Active comparator | Reflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration Receives: Dietary Supplement: Reflex Plus |
| Placebo | Placebo comparator | Placebo Sachets to be taken once in a day Before breakfast for the study duration Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 weeks for protocol B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fullife Healthcare Pvt Ltd
- Responsible party
- Sponsor
- Investigators
- Dr Sachin Dighe, B.A.M.S., Study director, sachin.d@vediclifesciences.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655939
- Sponsor's protocol ID
- FZ/150603/RFX+/OA
- Status last verified
- Mar 2017
- First submitted
- 2 Dec 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Multicentre, Placebo Controlled Study to Assess the Efficacy and Safety of Reflex Plus™ in Osteoarthritis
- ClinicalTrials.gov ID
- NCT02655939
- Acronym / sponsor ID
- FZ/150603/RFX+/OA
- Conditions
- Osteoarthritis
- Keywords
- Gonarthrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fullife Healthcare Pvt Ltd
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflex Plus | Active comparator | Dietary Supplement: Reflex PlusReflex Plus TM, Sachets to be taken once in a day Before breakfast for the study duration |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo Sachets to be taken once in a day Before breakfast for the study duration |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflex PlusCollagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g, | Dietary supplement | Reflex Plus |
| PlaceboFructose,Orange flavor and sucralose | Dietary supplement | Placebo |
Primary outcome
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 12.
Time frame: 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.
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 24.
Time frame: 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.
5 secondary outcomes
Reduction in anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 12.
Time frame: 12 week for protocol A
Reduction of anti-inflammatory markers measured as change from baseline in Serum C reactive protein (CRP) at Week 24.
Time frame: 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
Time frame: 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
Time frame: 24 week for protocol B
Improvement in structure cartilage of knee joint measured as change in MRI analysis from baseline to Week 24.
Time frame: 24 weeks for protocol B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sachin Dighe, B.A.M.S. study director
sachin.d@vediclifesciences.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reflex Plus in people with Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction from baseline in total score of WOMAC osteoarthritis index at Week 12. (time frame: 12 week for protocol A). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.