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Osteo Arthritis KneeNCT04395547

Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis

A study testing JointAlive™ in people with Osteo Arthritis Knee, run by Chenland Nutritionals Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Osteoarthritis (OA) is a joint disorder caused by wear and tear on the joint over time; as a result, the protective cartilage of the bone in the joint gradually wears down. The lifetime risk of developing OA in the knee, with symptoms such as pain, aching, and stiffness, is 40% in men and 47% in women. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
JointAlive™
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteCanada
Study dates
15 Jun 2020to 27 May 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females between 40 and 75 years of age, inclusive
  • BMI between 18.5 to 29.9 kg/m2, inclusive
  • Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
  • Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
Show all 17Show fewer
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
  • Self-reported pain or swelling in target knee
  • The diagnosis of mild to moderate osteoarthritis as confirmed by the Qualified Investigator using qualifiers based on physical exam, medical history and x-ray report qualified as mild to moderate by the radiologist
  • Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
  • Agrees to refrain from taking rescue medication for 48 hours prior to study visits
  • Agrees to maintain current diet and current exercise routine throughout the study
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  • Provided voluntary, written, informed consent to participate in the study
  • Healthy as determined by medical history, laboratory results, and physical exam as assessed by the Qualified Investigator (QI)

Who cannot join

  • Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
  • Allergy to rescue medication
  • Women who are pregnant, breast feeding, or planning to become pregnant during the study
  • Clinically significant abnormal laboratory results at baseline as assessed by the QI
  • Individuals who are unable to give informed consent
  • Injury in the target knee within the past 3 months
Show all 43Show fewer
  • Intraarticular injections in the target knee within the past 6 months, or plan to have intraarticular injections during the study
  • Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis, septic arthritis or any other infective arthritis
  • Self-reported history of gout or pseudo gout within the past 6 months
  • Skin defects (e.g. skin and soft tissue infections that cause necrosis of the skin, or post-burn contractures) and ulcers around the affected knee joint, as assessed by the QI
  • History of knee surgery or replacement in the target knee, or any non-knee surgical procedures that may impact the study outcomes as assessed by the QI
  • Individuals with muscle or skeletal disorders as assessed by the QI
  • Unstable metabolic disease or chronic diseases as assessed by the QI
  • In a state of acute exacerbation or seizure of chronic disease
  • Type I or Type II diabetes
  • History of or current diagnosis with severe cardiopulmonary, kidney and/or liver dysfunctions, with the exception of history of kidney stones in participants who are symptom free for 6 months
  • Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  • Current or history of any significant diseases of the gastrointestinal tract including diarrhea or dysentery as assessed by the QI
  • Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
  • Self-reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
  • Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  • Verbal confirmation of blood/bleeding disorders as assessed by the QI
  • Individuals with an acute infectious disease, autoimmune disease or are immune-compromised
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
  • Current use of prescribed medications listed above
  • Current use of over-the-counter medications, supplements, foods and/or drinks listed above
  • Use of medical cannabinoid products
  • Chronic use of cannabinoid products (>2 times/week) and is unwilling to stop use for the duration of the study. Occasional use to be assessed by the QI on a case-by-case basis
  • Alcohol or drug abuse within the last 12 months
  • High alcohol intake (average of >2 standard drinks per day)
  • Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to screening
  • Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
  • Participants on the following concurrent prescribed medications and/or treatments will be excluded during enrollment unless they have been taken off these therapies by their family physician. In the latter event, the frequency and route of administration of use and/or dosage may be considered by the QI on a case-by-case basis prior to recommending an appropriate washout or their enrollment in the study.
  • Oral NSAIDs or topical application on the target knee
  • Narcotics
  • Oral corticosteroids or topical application on the target knee
  • Oral analgesics except acetaminophen as a rescue medication or topical application on the target knee
  • Digoxin
  • Anti-hypertensive drugs
  • Anticoagulants or antiplatelet drugs
  • Medications used for OA treatment
  • Diazepam

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Science Inc

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Safety and Efficacy of JointAlive™ on Improving Knee Joint Function in Adults With Mild to Moderate Knee Osteoarthritis

Osteoarthritis (OA) is a joint disorder caused by wear and tear on the joint over time; as a result, the protective cartilage of the bone in the joint gradually wears down. The lifetime risk of developing OA in the knee, with symptoms such as pain, aching, and stiffness, is 40% in men and 47% in women. It is estimated that approximately 19% of Americans aged 45 and older are affected by knee OA. Knee OA accounts for 83% of the global burden caused by all OA types. Pain and stiffness in knees, a large weight-bearing joint, often leads to disability, which interferes with daily life activities and demands expensive medical treatments or care. Due to the limitations of current OA treatment methods, there is an increasing demand for effective and safer alternatives, such as natural health products with pain-relieving potential. The investigational product, JointAlive™, is a supplement designed to alleviate knee OA symptoms and to improve knee functionality. The present study will investigate the safety and efficacy of JointAlive™ in reducing knee OA symptoms and improving joint functionality in an otherwise healthy adult population with mild to moderate knee OA. JointAlive™ is a proprietary blend of Epimedium brevicornum Maxim leaves, Dioscorea nipponica Makino rhizome, Salvia miltoiorrhiza Bunge root and rhizome extracts

Read the detailed description

Osteoarthritis (OA) is a joint disorder caused by wear and tear on the joint over time; as a result, the protective cartilage of the bone in the joint gradually wears down. The lifetime risk of developing OA in the knee, with symptoms such as pain, aching, and stiffness, is 40% in men and 47% in women. It is estimated that approximately 19% of Americans aged 45 and older are affected by knee OA. Knee OA accounts for 83% of the global burden caused by all OA types. Pain and stiffness in knees, a large weight-bearing joint, often leads to disability, which interferes with daily life activities and demands expensive medical treatments or care. Losina et al. reported that in the United States, the average lifetime costs for symptomatic knee OA management is $12,400 USD, but the cost can be higher with knee surgeries for advanced OA. The economic burden is expected to continue increasing in the near future due to the aging population and increasing prevalence of obesity in many developed countries.

Although the exact etiology of OA is unknown, many risk factors are associated with the development of knee OA, such as obesity, repetitive use of joints, age, and previous knee injury or surgery. Multiple studies have shown a positive association between pro-inflammatory cytokines (e.g. tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and IL-6) and OA development. Cytokine-induced nuclear factor-κB (NF-κB) activation can stimulate articular chondrocyte catabolism and extracellular matrix degradation, leading to the breakdown of articular cartilage. The severity of cartilage disintegration and osteophyte (a bony outgrowth) formation can be identified radiographically and used for the Kellgren-Lawrence (KL) grading scheme. A KL score of one (doubtful narrowing of the joint space with possible osteophyte formation) is considered possible OA, while a score of two (possible narrowing of joint space with definite osteophyte formation) or three (definite narrowing of joint space and moderate osteophyte formation) is considered as a definite/mild OA.

It is crucial to treat OA early, before it develops into more severe cases and causes mobility disability. The first step of OA treatment is exercise and/or physiotherapy, which has demonstrated long-term benefits but often difficult to maintain compliance. Once the pain is difficult to manage, over-the-counter medicines such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are introduced to provide relief. NSAIDs are effective in reducing pain, however, long-term usage requires medical supervision. Chronic NSAID use is associated with high incidence of adverse events such as upper gastrointestinal tract problems, kidney and liver injury, hypertension, and congestive heart failure. When the abovementioned treatments are ineffective, intra-articular injections of hyaluronic acid, cortisol, or platelet rich plasma are applied and proven effective, but they can be costly and may cause reactive flares or infections at the injection site. Surgery serves as last resort; it is a successful treatment for advanced OA, but it is invasive and may increase risks of infection, bleeding, and deep vein thrombosis. Given the limitations of current OA treatment methods, there is an increasing demand for effective and safer alternatives, such as natural health products with pain-relieving potential.

The investigational product, JointAlive™, is a supplement designed to alleviate knee OA symptoms and to improve knee functionality. JointAlive™ contains extract from flowering plants that are endemic to China.The main bioactive component is icariin; a flavonoid glycoside demonstrating various antioxidant and anti-inflammatory benefits. Numerous in vitro cell culture studies showed that icariin has the potential to suppress inflammatory pathways involved in OA. In rodent OA models, joint injection of icariin for 32 and 84 days was found to protect the articular cartilage from degeneration.

The present study will investigate the safety and efficacy of JointAlive™ in reducing knee OA symptoms and improving joint functionality in an otherwise healthy adult population with mild to moderate knee OA. Based on the previous studies conducted on the ingredients of this investigational product and their previous application in OA, participants identifying mild or moderate OA in a target knee will be investigated in this study. As OA is a secondary complication in sports injuries as well as a primary development during aging, an age range between 40-75 years will be considered for enrolment. The Kellgren-Lawrence grading scale will be used to confirm OA. As well, BMI cut offs between 18.5 and 29.9 kg/m2 will be considered to excluded those with complications due to obesity and the associated increase in concomitant medication use. To allow for pain relief, as this study involves a placebo group, a rescue medication will be provided. However, in order to ensure that the capture of pain in the target knee is unbiased, participants will be required to abstain from the rescue medication use for 48 hours prior to their clinic visits. Confounders due to medical history and concomitant medications will be ensured by several targeted exclusion criteria with the intent of decreasing potential confounders of the study results.

Being tested
JointAlive™, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JointAlive™Dietary supplement

    Combination herbal extract

  • PlaceboDietary supplement

    Combination placebo product

Study groups in NCT04395547
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo
JointAlive™ExperimentalNot described
Receives: Dietary Supplement: JointAlive™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in knee joint function: Pain

    This will be determined by change in pain of the identified knee joint from baseline to 12-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. The lowest number represents no pain while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no pain and 100 being extreme pain.

    Measured: 12 weeks

  2. Change in knee joint function: Stiffness

    This will be determined by change in stiffness of the identified knee joint from baseline to 12-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible 0-8 for Stiffness. The lowest number represents no pain or stiffness while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no stiffness and 100 being extreme stiffness.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Change in Pain

    Change in pain of the identified knee joint from baseline to 6-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. The lowest number represents no pain while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no pain and 100 being extreme pain.

    Measured: 6 weeks

  2. Change in Stiffness

    Change in stiffness of the identified knee joint from baseline to 6-week post-supplementation between JointAlive™ and placebo, as assessed by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. Questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible 0-8 for Stiffness. The lowest number represents no pain or stiffness while the highest number represent extreme pain or stiffness. These are then converted to the Knee injury and Osteoarthritis Outcomes Score (KOOS) pain scores. KOOS scoring system ranges from 1-100, with 0 representing no stiffness and 100 being extreme stiffness.

    Measured: 6 weeks

  3. Knee OA symptoms as assessed by KOOS symptoms score

    KOOS Scores range from 0 to 100. A score of 0 indicates the worst possible knee symptoms and 100 indicates no knee symptoms.

    Measured: 6-12 weeks

  4. Daily physical function as assessed by KOOS in function daily living score

    The Scoring system ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems

    Measured: 6-12 weeks

  5. Physical function in sports and recreational activities as assessed by KOOS function in sports and recreational activities score

    The Scoring system ranges from 0 to 100, with 0 representing extreme problems with physical functions and 100 representing no problems

    Measured: 6-12 weeks

  6. Current pain as assessed by Pain Visual Analogue Scale (VAS) scores

    The Pain VAS questionnaire is a unidimensional measure of pain intensity. With the use of a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100 depending on pain intensity. A score of 0 represents no pain while a score of 100 represents extreme pain.

    Measured: 6-12 weeks

  7. Quality of life as assessed by Short Form 36 (SF-36) Questionnaire and KOOS quality of life score

    The Scoring system ranges from 0 to 100, with 0 representing poorest quality of life and 100 representing no problems

    Measured: 6-12 weeks

  8. Knee joint range of motion (flexion and extension) as assessed by a knee goniometer

    Measured: 6-12 weeks

  9. Serum level of C reactive protein (CRP)

    Measured: 6-12 weeks

  10. Use of acetaminophen as a rescue medication as assessed by study diary

    Measured: 6-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start15 Jun 2020
  3. Primary completion27 May 2022
  4. Study completion27 May 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395547
Sponsor's protocol ID
20GJHC
Status last verified
Dec 2022
First submitted
13 May 2020
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.

    PubMed 18163481

  • Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.

    PubMed 28808025

  • Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.

    PubMed 23245607

  • Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99. doi: 10.1093/bmb/lds038. Epub 2013 Jan 20.

    PubMed 23337796

  • Losina E, Paltiel AD, Weinstein AM, Yelin E, Hunter DJ, Chen SP, Klara K, Suter LG, Solomon DH, Burbine SA, Walensky RP, Katz JN. Lifetime medical costs of knee osteoarthritis management in the United States: impact of extending indications for total knee arthroplasty. Arthritis Care Res (Hoboken). 2015 Feb;67(2):203-15. doi: 10.1002/acr.22412.

    PubMed 25048053

  • Salmon JH, Rat AC, Sellam J, Michel M, Eschard JP, Guillemin F, Jolly D, Fautrel B. Economic impact of lower-limb osteoarthritis worldwide: a systematic review of cost-of-illness studies. Osteoarthritis Cartilage. 2016 Sep;24(9):1500-8. doi: 10.1016/j.joca.2016.03.012. Epub 2016 Mar 23.

    PubMed 27034093

  • Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

    PubMed 24024017

  • Chen D, Shen J, Zhao W, Wang T, Han L, Hamilton JL, Im HJ. Osteoarthritis: toward a comprehensive understanding of pathological mechanism. Bone Res. 2017 Jan 17;5:16044. doi: 10.1038/boneres.2016.44. eCollection 2017.

    PubMed 28149655

  • Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.

    PubMed 26872913

  • Felson DT, Hodgson R. Identifying and treating preclinical and early osteoarthritis. Rheum Dis Clin North Am. 2014 Nov;40(4):699-710. doi: 10.1016/j.rdc.2014.07.012. Epub 2014 Sep 12.

    PubMed 25437286

  • Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18.

    PubMed 25035839

  • Charlesworth J, Fitzpatrick J, Perera NKP, Orchard J. Osteoarthritis- a systematic review of long-term safety implications for osteoarthritis of the knee. BMC Musculoskelet Disord. 2019 Apr 9;20(1):151. doi: 10.1186/s12891-019-2525-0.

    PubMed 30961569

  • Fang J, Zhang Y. Icariin, an Anti-atherosclerotic Drug from Chinese Medicinal Herb Horny Goat Weed. Front Pharmacol. 2017 Oct 12;8:734. doi: 10.3389/fphar.2017.00734. eCollection 2017.

    PubMed 29075193

  • Chen SR, Xu XZ, Wang YH, Chen JW, Xu SW, Gu LQ, Liu PQ. Icariin derivative inhibits inflammation through suppression of p38 mitogen-activated protein kinase and nuclear factor-kappaB pathways. Biol Pharm Bull. 2010;33(8):1307-13. doi: 10.1248/bpb.33.1307.

    PubMed 20686223

  • Liu MH, Sun JS, Tsai SW, Sheu SY, Chen MH. Icariin protects murine chondrocytes from lipopolysaccharide-induced inflammatory responses and extracellular matrix degradation. Nutr Res. 2010 Jan;30(1):57-65. doi: 10.1016/j.nutres.2009.10.020.

    PubMed 20116661

Questions about this trial

What is this clinical trial studying?

A study testing JointAlive™ in people with Osteo Arthritis Knee, run by Chenland Nutritionals Inc. at 1 site in Canada.

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 17 inclusion and 43 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 23 Dec 2022. 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 Canada. 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?

Change in knee joint function: Pain (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT04395547, which also lists 38 linked publications.

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 23 Dec 2022.

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