Knee OsteoarthritisNCT04470336
To Assess the Efficacy of Collagen Supplement in Osteoarthritis
A study testing Collagen Supplement and Glucosamine chondroitin in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial summary
Collagen Supplement is a natural ingredient that contains undenatured collagen derived from chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Collagen Supplement and Glucosamine chondroitin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesIndia
- Study dates
- 9 Jul 2020to 12 Apr 2021
- Phase
- Interventional
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male \& female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3 months prior to screening.
- BMI ≥ 18.5 and ≤ 29.9 kg/m2.
- Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs).
- Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.
- Radiographic evidence of grade II/III knee OA based on one of following criteria.
- Participants willing to stop the restricted supplements and medications prior to inclusion and throughout the study period.
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- Participants willing to stop any home-based remedies or any other form of topical products intended for knee joint pain relief or any other reason for the entire study duration.
- Willing to stop the use of study designated rescue medication 48 hours prior to all assessment visits.
- Willing to abstain from food containing type II collagen only from cartilage, e.g. chicken, fish, beef, pork, etc. 48 hours prior to all assessment visits.
Who cannot join
- Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders, etc.), abnormal medical history or physical findings.
- Participants with history of type II diabetes and uncontrolled hypertension.
- Fasting Blood glucose > 125 mg/dl
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis.
- Any history of trauma, fractures or surgery to the index joint.
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- Any planned surgery (diagnostic or therapeutic intervention) to the index joint during the participation in the study.
- Participants with deformity of the knee joint.
- Participants with a diagnosed condition which may involve or involves the index joint that includes but is not limited to known rheumatic or inflammatory conditions such as rheumatoid arthritis, osteomyelitis, osteoporosis, gout, and bone metastasis.
- Other pathologic lesions on X-rays of the knee.
- Current smokers or chronic alcoholics
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Dr. Randive's knee and spine clinic
Mumbai, Maharashtra, 400093
PKC Hospital
Mumbai, Maharashtra, 400705
Dr Sonawane orthopedic clinic
Mumbai, Maharashtra, 400709
Rainbow Multispeciality hospital and trauma center
Navi Mumbai, Maharashtra, 400708
Shubham Sudbhawana Super Specialty Hospital
Varanasi, Uttar Pradesh, 221005
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis
Collagen Supplement is a natural ingredient that contains undenatured collagen derived from chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee Osteoarthritis
Read the detailed description
Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of cartilage in movable joints that leads to friction between bones creating pain, stiffness, and abnormal movement. It is estimated to affect more than 20% of the population over the age of 60 years and is considered to be a major cause of morbidity, disability, and limitations on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA being 2nd most common rheumatological disorder. , As global life expectancy increases, the prevalence of OA is expected to rise further ultimately resulting in a greater burden for healthcare. Currently, the management has largely been palliative, focusing on the alleviation of symptoms.
The principles of OA treatments primarily are to alleviate pain and stiffness and maintain function. The current treatment guidelines recommend a combination of physical therapy, use of analgesia with Acetaminophen or NSAIDs, and surgical intervention when deemed necessary. While medications slow the progression of OA and other inflammatory conditions, no proven disease-modifying agents for the treatment of knee OA currently exists. The majority of individuals are successfully managed with a combination of the aforementioned treatments, but there is still a significant group of patients in whom these treatments do not provide adequate relief. Furthermore, there remains a lack of treatments that have demonstrated effectiveness in stopping or reversing the degenerative process. , Besides, there are considerable side effects associated with the use of these drugs. As a result, OA sufferers have turned to natural nutraceuticals to ease their pain and discomfort.
In recent years, several novel agents have emerged as potential treatment alternatives to improve pain, stiffness, and function with the possibility of altering disease progression. These products are commonly used because they are well tolerated and considered safe. Among the OA patients, glucosamine and chondroitin are most commonly used and have shown to considerably reduce the pain associated with arthritis. From the nutraceutical point of view, there is a growing interest in Collagen Supplement as a solution for the treatment of OA. The Collagen Supplement has been studied extensively in both animals as well as human clinical studies. , Among animal studies, a study in the rat model of OA reported several benefits after treatment, suggesting its potential for the prevention of worsening of articular cartilage damage. In another study, porcine Collagen Supplement administration demonstrated a significant reduction of pain intensity. Also, a lower dose regimen showed meaningful pain reduction indicating its protective effect on the cartilage. Furthermore, several studies have evaluated the efficacy and safety of Collagen Supplement in individuals suffering from chronic OA. Crowley and colleagues showed that supplementation of Collagen Supplement for three months is more efficacious as compared to the combination of glucosamine plus chondroitin. In another study, 6-month administration of the Collagen Supplement significantly reduced pain, stiffness, and physical functioning as compared to glucosamine hydrochloride plus chondroitin sulfate group of participants with knee OA.
Based on the available evidence it is clear that Collagen Supplement is effective in improving joint discomfort associated with OA. Moreover, collagen products are also recognized as safe components of pharmaceutical and foods by the US Food and Drugs Administration Center for Food Safety and Nutrition. Hence, considering its symptomatic benefits, the structural effect on the cartilage and its important role in bone structure, Collagen Supplement is thought to be a viable alternative for OA patients. , Therefore, the present study aimed to evaluate the safety and efficacy of an collagen supplementation in participants suffering from knee OA. Study volunteers will be supplemented with Collagen Supplement, an collagen product for 12 weeks and assessed as per study designated efficacy and safety variables. Also, the efficacy and efficacy of Collagen Supplement will be compared with Glucosamine HCL plus chondroitin sulfate and placebo as per the set study intervals.
- Conditions
- Knee Osteoarthritis
- Being tested
- Collagen Supplement, Glucosamine chondroitin, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen SupplementOther
Three capsules post-breakfast Three capsules post-dinner
Glucosamine chondroitinOther
Three capsules post-breakfast Three capsules post-dinner
PlaceboOther
Three capsules post-breakfast Three capsules post-dinner
| Study group | Role | What they receive |
|---|---|---|
| Collagen Supplement | Active comparator | Three capsules post-breakfast Three capsules post-dinner Receives: Other: Collagen Supplement |
| Glucosamine chondroitin | Other | Three capsules post-breakfast Three capsules post-dinner Receives: Other: Glucosamine chondroitin |
| Placebo | Placebo comparator | Three capsules post-breakfast Three capsules post-dinner Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Western Ontario and McMaster Score
Effect of consumption of IP on Joint health as assessed by the change in the (mWOMAC) total score from baseline and when compared with the placebo. [From baseline to 84 days] High score defines worst outcome and low score defines better oucome.
Measured: Day0 Day 28 Day 56 Day 84
Secondary outcomes (2)
EQ-5D-5L
Effect of consumption of IP on Joint health as assessed by the change in the EQ-5D-5L from baseline and when compared with the placebo. [From baseline to 84 days]
Measured: Day 0 and Day 84
interleukin-6 (IL - 6)
Effect of consumption of IP on Joint inflammation as assessed by the change in the inflammatory biomarker interleukin-6 (IL-6) concentration from baseline and when compared with the placebo. [From baseline to 84 days]
Measured: Day 0 Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start9 Jul 2020
- Primary completion24 Feb 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Shalini Srivastava, MD - Med., Study director, Vedic Life Sciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470336
- Sponsor's protocol ID
- JHB/190702/NATIVECTII/OA
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo C, Su W, Song Y, Srivastava S. Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double-blind, placebo-controlled trial. J Exp Orthop. 2022 Dec 23;9(1):123. doi: 10.1186/s40634-022-00559-8.
PubMed 36562843
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis
- ClinicalTrials.gov ID
- NCT04470336
- Acronym / sponsor ID
- JHB/190702/NATIVECTII/OA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
Collagen Supplement is a natural ingredient that contains undenatured collagen derived from chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee Osteoarthritis
Detailed description
Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of cartilage in movable joints that leads to friction between bones creating pain, stiffness, and abnormal movement. It is estimated to affect more than 20% of the population over the age of 60 years and is considered to be a major cause of morbidity, disability, and limitations on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA being 2nd most common rheumatological disorder. , As global life expectancy increases, the prevalence of OA is expected to rise further ultimately resulting in a greater burden for healthcare. Currently, the management has largely been palliative, focusing on the alleviation of symptoms.
The principles of OA treatments primarily are to alleviate pain and stiffness and maintain function. The current treatment guidelines recommend a combination of physical therapy, use of analgesia with Acetaminophen or NSAIDs, and surgical intervention when deemed necessary. While medications slow the progression of OA and other inflammatory conditions, no proven disease-modifying agents for the treatment of knee OA currently exists. The majority of individuals are successfully managed with a combination of the aforementioned treatments, but there is still a significant group of patients in whom these treatments do not provide adequate relief. Furthermore, there remains a lack of treatments that have demonstrated effectiveness in stopping or reversing the degenerative process. , Besides, there are considerable side effects associated with the use of these drugs. As a result, OA sufferers have turned to natural nutraceuticals to ease their pain and discomfort.
In recent years, several novel agents have emerged as potential treatment alternatives to improve pain, stiffness, and function with the possibility of altering disease progression. These products are commonly used because they are well tolerated and considered safe. Among the OA patients, glucosamine and chondroitin are most commonly used and have shown to considerably reduce the pain associated with arthritis. From the nutraceutical point of view, there is a growing interest in Collagen Supplement as a solution for the treatment of OA. The Collagen Supplement has been studied extensively in both animals as well as human clinical studies. , Among animal studies, a study in the rat model of OA reported several benefits after treatment, suggesting its potential for the prevention of worsening of articular cartilage damage. In another study, porcine Collagen Supplement administration demonstrated a significant reduction of pain intensity. Also, a lower dose regimen showed meaningful pain reduction indicating its protective effect on the cartilage. Furthermore, several studies have evaluated the efficacy and safety of Collagen Supplement in individuals suffering from chronic OA. Crowley and colleagues showed that supplementation of Collagen Supplement for three months is more efficacious as compared to the combination of glucosamine plus chondroitin. In another study, 6-month administration of the Collagen Supplement significantly reduced pain, stiffness, and physical functioning as compared to glucosamine hydrochloride plus chondroitin sulfate group of participants with knee OA.
Based on the available evidence it is clear that Collagen Supplement is effective in improving joint discomfort associated with OA. Moreover, collagen products are also recognized as safe components of pharmaceutical and foods by the US Food and Drugs Administration Center for Food Safety and Nutrition. Hence, considering its symptomatic benefits, the structural effect on the cartilage and its important role in bone structure, Collagen Supplement is thought to be a viable alternative for OA patients. , Therefore, the present study aimed to evaluate the safety and efficacy of an collagen supplementation in participants suffering from knee OA. Study volunteers will be supplemented with Collagen Supplement, an collagen product for 12 weeks and assessed as per study designated efficacy and safety variables. Also, the efficacy and efficacy of Collagen Supplement will be compared with Glucosamine HCL plus chondroitin sulfate and placebo as per the set study intervals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collagen Supplement | Active comparator | Other: Collagen SupplementThree capsules post-breakfast Three capsules post-dinner |
| Glucosamine chondroitin | Other | Other: Glucosamine chondroitinThree capsules post-breakfast Three capsules post-dinner |
| Placebo | Placebo comparator | Other: PlaceboThree capsules post-breakfast Three capsules post-dinner |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male \& female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3 months prior to screening.
- BMI ≥ 18.5 and ≤ 29.9 kg/m2.
- Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs).
- Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.
- Radiographic evidence of grade II/III knee OA based on one of following criteria.
Key exclusion criteria (11 listed)
- Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders, etc.), abnormal medical history or physical findings.
- Participants with history of type II diabetes and uncontrolled hypertension.
- Fasting Blood glucose > 125 mg/dl
- Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis.
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 |
|---|---|---|
| Collagen SupplementThree capsules post-breakfast Three capsules post-dinner | Other | Collagen Supplement |
| Glucosamine chondroitinThree capsules post-breakfast Three capsules post-dinner | Other | Glucosamine chondroitin |
| PlaceboThree capsules post-breakfast Three capsules post-dinner | Other | Placebo |
Primary outcome
modified Western Ontario and McMaster Score
Time frame: Day0 Day 28 Day 56 Day 84
Effect of consumption of IP on Joint health as assessed by the change in the (mWOMAC) total score from baseline and when compared with the placebo. [From baseline to 84 days] High score defines worst outcome and low score defines better oucome.
2 secondary outcomes
EQ-5D-5L
Time frame: Day 0 and Day 84
interleukin-6 (IL - 6)
Time frame: Day 0 Day 84
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 30 Apr 2021.
- Derived from this study: PubMed 36562843Luo C, Su W, Song Y, Srivastava S. Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double-blind, placebo-controlled trial. J Exp Orthop. 2022 Dec 23;9(1):123. doi: 10.1186/s40634-022-00559-8.
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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. Shalini Srivastava, MD - Med. study director
Vedic Life Sciences Pvt. Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Supplement and Glucosamine chondroitin in people with Knee Osteoarthritis, run by Vedic Lifesciences Pvt. Ltd. at 5 sites 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 11 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
modified Western Ontario and McMaster Score (time frame: Day0 Day 28 Day 56 Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470336, which also lists 1 linked publication.
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 30 Apr 2021.