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To Assess the Efficacy of Native CT-II in Osteoarthritis

To Assess the Efficacy of Native CT-II in Osteoarthritis

Recruiting
40-65 years
All
Phase N/A

Overview

Native CT-II is a natural ingredient that contains undenatured type-II collagen derived from chicken sternum. Undenatured type II collagen in Native CT-II is efficacious and safe as compared to placebo and efficacy is also comparable to glucosamine plus chondroitin for treatment of of knee Osteoarthritis

Eligibility

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study details
    Osteoarthritis of knee
    Osteoarthritis
    Osteoarthritis

NCT04470336

Vedic Lifesciences Pvt. Ltd.

5 August 2020

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