To Assess the Efficacy of Native CT-II in Osteoarthritis

  • STATUS
    Recruiting
  • participants needed
    117
  • sponsor
    Vedic Lifesciences Pvt. Ltd.
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Updated on 5 August 2020
See if I qualify
osteoarthritis
arthralgia
pain relief
knee pain
glucosamine
chondroitin

Summary

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

Details
Condition Osteoarthritis of knee, Osteoarthritis, Osteoarthritis
Age 40years - 65years
Treatment Placebo, Native CT -II, Glucosamine chondroitin
Clinical Study IdentifierNCT04470336
SponsorVedic Lifesciences Pvt. Ltd.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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