Status:
COMPLETED
To Assess the Efficacy of Collagen Supplement in Osteoarthritis
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
Collagen Supplement is a natural ingredient that contains undenatured collagen derived from chicken sternum. Collagen Supplement is efficacious and safe as compared to placebo and efficacy is also com...
Detailed Description
Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of cartilage in movable joints that leads to friction between bones creating pain, stiffness, and abnormal movement...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04470336
Start Date
July 9 2020
End Date
April 12 2021
Last Update
April 30 2021
Active Locations (5)
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1
Dr. Randive's knee and spine clinic
Mumbai, Maharashtra, India, 400093
2
PKC Hospital
Mumbai, Maharashtra, India, 400705
3
Dr Sonawane orthopedic clinic
Mumbai, Maharashtra, India, 400709
4
Rainbow Multispeciality hospital and trauma center
Navi Mumbai, Maharashtra, India, 400708