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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395547
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Chenland Nutritionals Inc.

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

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Dietary Supplement: JointAlive™ Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
Combination placebo product

Experimental: JointAlive™ Dietary Supplement: JointAlive™
Combination herbal extract




Primary Outcome Measures :
  1. Change in knee joint function: Pain [ Time Frame: 12 weeks ]
    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.

  2. Change in knee joint function: Stiffness [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Pain [ Time Frame: 6 weeks ]
    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.

  2. Change in Stiffness [ Time Frame: 6 weeks ]
    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.

  3. Knee OA symptoms as assessed by KOOS symptoms score [ Time Frame: 6-12 weeks ]
    KOOS Scores range from 0 to 100. A score of 0 indicates the worst possible knee symptoms and 100 indicates no knee symptoms.

  4. Daily physical function as assessed by KOOS in function daily living score [ Time Frame: 6-12 weeks ]
    The Scoring system ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems

  5. Physical function in sports and recreational activities as assessed by KOOS function in sports and recreational activities score [ Time Frame: 6-12 weeks ]
    The Scoring system ranges from 0 to 100, with 0 representing extreme problems with physical functions and 100 representing no problems

  6. Current pain as assessed by Pain Visual Analogue Scale (VAS) scores [ Time Frame: 6-12 weeks ]
    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.

  7. Quality of life as assessed by Short Form 36 (SF-36) Questionnaire and KOOS quality of life score [ Time Frame: 6-12 weeks ]
    The Scoring system ranges from 0 to 100, with 0 representing poorest quality of life and 100 representing no problems

  8. Knee joint range of motion (flexion and extension) as assessed by a knee goniometer [ Time Frame: 6-12 weeks ]
  9. Serum level of C reactive protein (CRP) [ Time Frame: 6-12 weeks ]
  10. Use of acetaminophen as a rescue medication as assessed by study diary [ Time Frame: 6-12 weeks ]

Other Outcome Measures:
  1. Incidence of pre-emergent and post-emergent adverse events [ Time Frame: 12 weeks ]
  2. Blood pressure (BP) [ Time Frame: 12 weeks ]
    Diastolic and systolic blood pressure (BP) after 6 and 12 weeks of supplementation with JointAlive™

  3. Heart Rate [ Time Frame: 12 weeks ]
    Heart rate (HR) after 6 and 12 weeks of supplementation with JointAlive™

  4. Change alanine aminotransferase (ALT) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  5. Change aspartate aminotransferase (AST) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  6. Change alkaline phosphatase (ALP), after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  7. Change in total bilirubin after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  8. Change in total creatinine after 12 weeks of supplementation with JointAlive™ compared to placebo [ Time Frame: 12 weeks ]
  9. Change in electrolytes (Na+, K+, Cl-) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  10. Change in estimated glomerular filtration rate (eGFR) after 12 weeks of supplementation with JointAlive™ compared to placebo [ Time Frame: 12 weeks ]
  11. Change in white blood cell (WBC) count after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  12. Change in neutrophils after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  13. Change in lymphocytes after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  14. Change in monocytes after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  15. Change in eosinophils after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  16. Change in basophils after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  17. Change in red blood cell (RBC) count after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  18. Change in hemoglobin after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  19. Change in hematocrit after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  20. Change in platelet count after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  21. Change in mean corpuscular volume (MCV) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  22. Change in mean corpuscular hemoglobin (MCH) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  23. Change in mean corpuscular hemoglobin concentration (MCHC) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  24. Change in red cell distribution width (RDW) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]
  25. Change in mean platelet volume (MPV) after 12 weeks of supplementation with JointAlive™ compared to placebo. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females between 40 and 75 years of age, inclusive
  2. BMI between 18.5 to 29.9 kg/m2, inclusive
  3. 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
  4. Self-reported pain or swelling in target knee
  5. 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
  6. Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
  7. Agrees to refrain from taking rescue medication for 48 hours prior to study visits
  8. Agrees to maintain current diet and current exercise routine throughout the study
  9. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  10. Provided voluntary, written, informed consent to participate in the study
  11. Healthy as determined by medical history, laboratory results, and physical exam as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

  1. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
  2. Allergy to rescue medication
  3. Women who are pregnant, breast feeding, or planning to become pregnant during the study
  4. Clinically significant abnormal laboratory results at baseline as assessed by the QI
  5. Individuals who are unable to give informed consent
  6. Injury in the target knee within the past 3 months
  7. Intraarticular injections in the target knee within the past 6 months, or plan to have intraarticular injections during the study
  8. Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis, septic arthritis or any other infective arthritis
  9. Self-reported history of gout or pseudo gout within the past 6 months
  10. 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
  11. 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
  12. Individuals with muscle or skeletal disorders as assessed by the QI
  13. Unstable metabolic disease or chronic diseases as assessed by the QI
  14. In a state of acute exacerbation or seizure of chronic disease
  15. Type I or Type II diabetes
  16. 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
  17. 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
  18. Current or history of any significant diseases of the gastrointestinal tract including diarrhea or dysentery as assessed by the QI
  19. 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
  20. Self-reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
  21. 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
  22. Verbal confirmation of blood/bleeding disorders as assessed by the QI
  23. Individuals with an acute infectious disease, autoimmune disease or are immune-compromised
  24. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
  25. Current use of prescribed medications listed above
  26. Current use of over-the-counter medications, supplements, foods and/or drinks listed above
  27. Use of medical cannabinoid products
  28. 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
  29. Alcohol or drug abuse within the last 12 months
  30. High alcohol intake (average of >2 standard drinks per day)
  31. Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
  32. Participation in other clinical research studies 30 days prior to screening
  33. 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.

  1. Oral NSAIDs or topical application on the target knee
  2. Narcotics
  3. Oral corticosteroids or topical application on the target knee
  4. Oral analgesics except acetaminophen as a rescue medication or topical application on the target knee
  5. Digoxin
  6. Anti-hypertensive drugs
  7. Anticoagulants or antiplatelet drugs
  8. Medications used for OA treatment
  9. Diazepam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395547


Contacts
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Contact: Malkanthi Evans, PhD 5194389374 ext 239 mevans@kgkscience.com
Contact: Andrew Charrette, MSc 5194389374 ext 232 acharrette@kgkscience.com

Locations
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Canada, Ontario
KGK Science Inc
London, Ontario, Canada, N6A 5R8
Contact: Malkanthi Evans, PhD    5194389374 ext 239    mevans@kgkscience.com   
Contact: Andrew Charrette, MSc    5194389374 ext 232    acharette@kgkscience.com   
Principal Investigator: Crowley David, MD         
Sponsors and Collaborators
Chenland Nutritionals Inc.
KGK Science Inc.
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.
Additional Information:
Publications:
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, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé 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, Fèvre 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 Leòn 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. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].

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Responsible Party: Chenland Nutritionals Inc.
ClinicalTrials.gov Identifier: NCT04395547    
Other Study ID Numbers: 20GJHC
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases