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

NCT04395547 | Completed

• 1 other identifier: 20GJHC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• 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.

  12 weeks

Secondary Outcomes (10)

• Change in Pain

  6 weeks

• Change in Stiffness

  6 weeks

• Knee OA symptoms as assessed by KOOS symptoms score

  6-12 weeks

• Daily physical function as assessed by KOOS in function daily living score

  6-12 weeks

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

  6-12 weeks

Other Outcomes (25)

• Incidence of pre-emergent and post-emergent adverse events

  12 weeks

• Blood pressure (BP)

  12 weeks

• Heart Rate

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

JointAlive™

EXPERIMENTAL

Dietary Supplement: JointAlive™

Interventions

JointAlive™ DIETARY_SUPPLEMENT

Combination herbal extract

JointAlive™

Placebo DIETARY_SUPPLEMENT

Combination placebo product

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chenland Nutritionals Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc

London, Ontario, N6A 5R8, Canada

Location

Related Publications (38)

• 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.

  PMID: 18163481 BACKGROUND

• 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.

  PMID: 28808025 BACKGROUND

• 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.

  PMID: 23245607 BACKGROUND

• 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.

  PMID: 23337796 BACKGROUND

• 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.

  PMID: 25048053 BACKGROUND

• 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.

  PMID: 27034093 BACKGROUND

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

  PMID: 24024017 BACKGROUND

• 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.

  PMID: 28149655 BACKGROUND

• 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.

  PMID: 26872913 BACKGROUND

• 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.

  PMID: 25437286 BACKGROUND

• 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.

  PMID: 25035839 BACKGROUND

• 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.

  PMID: 30961569 BACKGROUND

• 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.

  PMID: 29075193 BACKGROUND

• 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.

  PMID: 20686223 BACKGROUND

• 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.

  PMID: 20116661 BACKGROUND

• Zu Y, Mu Y, Li Q, Zhang ST, Yan HJ. Icariin alleviates osteoarthritis by inhibiting NLRP3-mediated pyroptosis. J Orthop Surg Res. 2019 Sep 11;14(1):307. doi: 10.1186/s13018-019-1307-6.

  PMID: 31511005 BACKGROUND

• Yan N, Wen DS, Zhao YR, Xu SJ. Epimedium sagittatum inhibits TLR4/MD-2 mediated NF-kappaB signaling pathway with anti-inflammatory activity. BMC Complement Altern Med. 2018 Nov 13;18(1):303. doi: 10.1186/s12906-018-2363-x.

  PMID: 30424767 BACKGROUND

• Wang P, Zhang F, He Q, Wang J, Shiu HT, Shu Y, Tsang WP, Liang S, Zhao K, Wan C. Flavonoid Compound Icariin Activates Hypoxia Inducible Factor-1alpha in Chondrocytes and Promotes Articular Cartilage Repair. PLoS One. 2016 Feb 3;11(2):e0148372. doi: 10.1371/journal.pone.0148372. eCollection 2016.

  PMID: 26841115 BACKGROUND

• Pan L, Zhang Y, Chen N, Yang L. Icariin Regulates Cellular Functions and Gene Expression of Osteoarthritis Patient-Derived Human Fibroblast-Like Synoviocytes. Int J Mol Sci. 2017 Dec 8;18(12):2656. doi: 10.3390/ijms18122656.

  PMID: 29292760 BACKGROUND

• Luo Y, Zhang Y, Huang Y. Icariin Reduces Cartilage Degeneration in a Mouse Model of Osteoarthritis and is Associated with the Changes in Expression of Indian Hedgehog and Parathyroid Hormone-Related Protein. Med Sci Monit. 2018 Sep 23;24:6695-6706. doi: 10.12659/MSM.910983.

  PMID: 30244259 BACKGROUND

• Wang F, Shi L, Zhang Y, Wang K, Pei F, Zhu H, Shi Z, Tao T, Li Z, Zeng P, Wang X, Ji Q, Qin L, Xue Q. A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial. Evid Based Complement Alternat Med. 2018 Feb 12;2018:1827528. doi: 10.1155/2018/1827528. eCollection 2018.

  PMID: 29619064 BACKGROUND

• Wang L, Ma R, Liu C, Liu H, Zhu R, Guo S, Tang M, Li Y, Niu J, Fu M, Gao S, Zhang D. Salvia miltiorrhiza: A Potential Red Light to the Development of Cardiovascular Diseases. Curr Pharm Des. 2017;23(7):1077-1097. doi: 10.2174/1381612822666161010105242.

  PMID: 27748194 BACKGROUND

• Ma S, Zhang D, Lou H, Sun L, Ji J. Evaluation of the anti-inflammatory activities of tanshinones isolated from Salvia miltiorrhiza var. alba roots in THP-1 macrophages. J Ethnopharmacol. 2016 Jul 21;188:193-9. doi: 10.1016/j.jep.2016.05.018. Epub 2016 May 10.

  PMID: 27178632 BACKGROUND

• Bai B, Li Y. Danshen prevents articular cartilage degeneration via antioxidation in rabbits with osteoarthritis. Osteoarthritis Cartilage. 2016 Mar;24(3):514-20. doi: 10.1016/j.joca.2015.10.004. Epub 2015 Oct 17.

  PMID: 26485068 BACKGROUND

• Xu X, Lv H, Li X, Su H, Zhang X, Yang J. Danshen attenuates osteoarthritis-related cartilage degeneration through inhibition of NF-kappaB signaling pathway in vivo and in vitro. Biochem Cell Biol. 2017 Dec;95(6):644-651. doi: 10.1139/bcb-2017-0025. Epub 2017 Jun 29.

  PMID: 28662337 BACKGROUND

• Xu X, Lv H, Li X, Su H, Zhang X, Yang J. Danshen attenuates cartilage injuries in osteoarthritis in vivo and in vitro by activating JAK2/STAT3 and AKT pathways. Exp Anim. 2018 May 10;67(2):127-137. doi: 10.1538/expanim.17-0062. Epub 2017 Oct 31.

  PMID: 29093428 BACKGROUND

• Ren J, Fu L, Nile SH, Zhang J, Kai G. Salvia miltiorrhiza in Treating Cardiovascular Diseases: A Review on Its Pharmacological and Clinical Applications. Front Pharmacol. 2019 Jul 5;10:753. doi: 10.3389/fphar.2019.00753. eCollection 2019.

  PMID: 31338034 BACKGROUND

• Ou-Yang SH, Jiang T, Zhu L, Yi T. Dioscorea nipponica Makino: a systematic review on its ethnobotany, phytochemical and pharmacological profiles. Chem Cent J. 2018 May 11;12(1):57. doi: 10.1186/s13065-018-0423-4.

  PMID: 29748731 BACKGROUND

• Junchao Y, Zhen W, Yuan W, Liying X, Libin J, Yuanhong Z, Wei Z, Ruilin C, Lu Z. Anti- trachea inflammatory effects of diosgenin from Dioscorea nipponica through interactions with glucocorticoid receptor alpha. J Int Med Res. 2017 Feb;45(1):101-113. doi: 10.1177/0300060516676724. Epub 2016 Dec 7.

  PMID: 27913746 BACKGROUND

• Zhao X, Yin L, Fang L, Xu L, Sun P, Xu M, Liu K, Peng J. Protective effects of dioscin against systemic inflammatory response syndromevia adjusting TLR2/MyD88/NF-kappab signal pathway. Int Immunopharmacol. 2018 Dec;65:458-469. doi: 10.1016/j.intimp.2018.10.036. Epub 2018 Oct 31.

  PMID: 30390593 BACKGROUND

• Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.

  PMID: 27012756 BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Rosemann T, Joos S, Koerner T, Szecsenyi J, Laux G. Comparison of AIMS2-SF, WOMAC, x-ray and a global physician assessment in order to approach quality of life in patients suffering from osteoarthritis. BMC Musculoskelet Disord. 2006 Jan 26;7:6. doi: 10.1186/1471-2474-7-6.

  PMID: 16438717 BACKGROUND

• Berenbaum F, Grifka J, Brown JP, Zacher J, Moore A, Krammer G, Dutta D, Sloan VS. Efficacy of lumiracoxib in osteoarthritis: a review of nine studies. J Int Med Res. 2005 Jan-Feb;33(1):21-41. doi: 10.1177/147323000503300102.

  PMID: 15651713 BACKGROUND

• Wessel J. The reliability and validity of pain threshold measurements in osteoarthritis of the knee. Scand J Rheumatol. 1995;24(4):238-42. doi: 10.3109/03009749509100881.

  PMID: 7481589 BACKGROUND

• Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage. 2007 Mar;15(3):273-80. doi: 10.1016/j.joca.2006.09.001. Epub 2006 Oct 17.

  PMID: 17052924 BACKGROUND

• Giordano N, Fioravanti A, Papakostas P, Montella A, Giorgi G, Nuti R. The efficacy and tolerability of glucosamine sulfate in the treatment of knee osteoarthritis: A randomized, double-blind, placebo-controlled trial. Curr Ther Res Clin Exp. 2009 Jun;70(3):185-96. doi: 10.1016/j.curtheres.2009.05.004.

  PMID: 24683229 BACKGROUND

• Li L, Wang Y, Wang S, Zong J, Zhang Z, Zou S, Zhao Z, Cao Y, Liu Z. A Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety and Efficacy of a Herbal Formulation on Knee Joint Function in Adults with Knee Osteoarthritis. J Integr Complement Med. 2025 Jan;31(1):54-63. doi: 10.1089/jicm.2023.0124. Epub 2024 Oct 14.

  PMID: 39400265 DERIVED

Related Links

• FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
• KOOS Scoring guide

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 20, 2020
• Study Start: June 15, 2020
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)