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A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee. (13GOHJ)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02604381
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Joint Health Wellness Group, LLC.
Information provided by (Responsible Party):
KGK Science Inc.

Brief Summary:
The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Dietary Supplement: Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Double Blind, Placebo Controlled Parallel Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
Study Start Date : November 2015
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017


Arm Intervention/treatment
Experimental: Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract
2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day.
Dietary Supplement: Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract
Placebo Comparator: Placebo
2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day.
Other: Placebo



Primary Outcome Measures :
  1. WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain [ Time Frame: 12 weeks ]
    Assessed at screening and every visit.


Secondary Outcome Measures :
  1. WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain [ Time Frame: 12 weeks ]
    Measured at screening and every visit. Within group changes assessed

  2. WOMAC™ Osteoarthritis Index Total Score as a measure of Osteoarthritis [ Time Frame: 12 weeks ]
    Measured at screening and every visit

  3. WOMAC™ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness [ Time Frame: 12 weeks ]
    Measured at screening and every visit

  4. WOMAC™ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function [ Time Frame: 12 weeks ]
    Measured at screening and every visit

  5. Rand SF-36 questionnaire score as a measure of Quality of Life [ Time Frame: 12 weeks ]
    Measured at every visit

  6. Cartilage Oligomeric Matrix Protein (COMP) [ Time Frame: 12 weeks ]
  7. IL-1 Beta [ Time Frame: 12 weeks ]
  8. Amount of rescue medication used [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Safety Blood Panel [ Time Frame: Over 12 weeks ]
  2. Blood Pressure [ Time Frame: Over 12 weeks ]
  3. Heart Rate [ Time Frame: Over 12 weeks ]
  4. BMI [ Time Frame: Over 12 weeks ]
  5. Incidence of Adverse Events [ Time Frame: Over 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 45-70 years of age
  • Body mass index (BMI) 18.0-39.9 kg/m2
  • If female, subject is not of child bearing potential OR female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
  • Primary or secondary, unilateral or bilateral osteoarthritis of the knee (American College of Rheumatology Clinical Criteria for Classification) characterized as knee pain with at least 3 of the following:
  • Age > 50 years
  • Stiffness < 30 minutes
  • Crepitus
  • Bony Tenderness
  • Bony enlargement
  • No palpable warmth
  • Self reported difficulty performing at least one of the following activities because of knee pain:
  • lifting and carrying groceries
  • walking one-quarter of a mile
  • getting in and out of a chair
  • going up and down stairs
  • mobility
  • self-care activities
  • Able to walk unassisted (may use walking stick, crutch, or knee brace)
  • Availability for duration of the study period (2 week run-in +12 weeks)
  • Subject agrees not to use over-the-counter medications or natural health products intended to treat OA pain during the run-in period and throughout the study (except the rescue medication provided).
  • Subject using other therapies for OA, such as exercise, heat/cold therapy, joint protection and physiotherapy/occupational therapy agrees to continue these therapies as normal avoiding changes in frequency or intensity and to record therapies in the study diary
  • Subject agrees not to start any new therapies for OA during the course of the study
  • Agrees to maintain current exercise and dietary habits for the duration of the study
  • Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Physical examination findings show severe articular inflammation
  • Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, spinal disorders or other musculoskeletal disease
  • Subject has been recommended for knee surgery
  • WOMAC Pain Scale Score <4 for total pain (average of question #1 to question #5) at screening and baseline
  • Subject has kidney or liver disease, blood disorders, active cancer and/or HIV infection
  • Subjects with significant medical history or current metabolic disorders, thyroid disease, immune disorders and/or cardiovascular disease will be reviewed by the Qualified Investigator (QI). Subjects deemed by the QI to be at possible risk will not be permitted in this study.
  • Subjects with a Type I or II diabetes
  • Subjects with a history of seizures who are currently on medication to control seizures
  • Subjects with hypertension will be reviewed by the Qualified Investigator (QI). If the subject is considered to be at risk they will not be permitted in this study
  • Subjects with a history of reoccurring palpitations or dizziness
  • Use of illicit drugs or history of drug or alcohol abuse with the past 2 years (currently having more than 2 standard alcoholic drinks per day)
  • Planned surgery during the course of the trial
  • Use of intra-articular, oral or parenteral corticosteroids, or other injectable prescription medication (e.g., Synvisc) within 2 months prior to randomization and during the trial
  • Subjects taking prescription medication that affect blood coagulation (e.g. blood thinners, clotting factor replacements, acetylsalicylic acid)
  • Subjects regularly taking over-the-counter medication (e.g. acetylsalicylic acid, ibuprofen) or natural health products (i.e. fish oils, vitamin E) that affect blood coagulation within 2 weeks of randomization
  • Requires the use of prescription drugs to control pain (other than provided rescue medication)
  • Use of oral or topical prescription or over the counter medications or natural health products for pain relief during the run-in period and during the trial (other than provided rescue medication, rescue medication should not be used within 72 hours prior to baseline and subsequent visits)
  • Use of vitamins and minerals or natural health products/dietary supplements indicated for arthritis such as glucosamine and chondroitin sulfate within 2 weeks prior to the run-in period and during the trial
  • Clinically significant abnormal laboratory results at screening (i.e. ≥ 2 times the ULN)
  • Allergy or sensitivity to test product ingredients, including shellfish
  • Allergy or sensitivity to acetaminophen, the rescue medication
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

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): NCT02604381


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Joint Health Wellness Group, LLC.
Investigators
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Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.
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Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02604381    
Other Study ID Numbers: 13GOHJ
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Keywords provided by KGK Science Inc.:
Osteoarthritis
Knee
Glucosamine Sulfate
Ginkgo Biloba
WOMAC
Joint Health Wellness
Interleukin-1-beta
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases