To Assess the Efficacy of Collagen Supplement in Osteoarthritis

NCT04470336 | Completed

• 1 other identifier: JHB/190702/NATIVECTII/OA
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

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 comparable to glucosamine plus chondroitin for treatment of of knee Osteoarthritis

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• modified Western Ontario and McMaster Score

  Effect of consumption of IP on Joint health as assessed by the change in the (mWOMAC) total score from baseline and when compared with the placebo. \[From baseline to 84 days\] High score defines worst outcome and low score defines better oucome.

  Day0 Day 28 Day 56 Day 84

Secondary Outcomes (2)

• EQ-5D-5L

  Day 0 and Day 84

• interleukin-6 (IL - 6)

  Day 0 Day 84

Study Arms (3)

Collagen Supplement

ACTIVE COMPARATOR

Three capsules post-breakfast Three capsules post-dinner

Other: Collagen Supplement

Glucosamine chondroitin

OTHER

Three capsules post-breakfast Three capsules post-dinner

Other: Glucosamine chondroitin

Placebo

PLACEBO COMPARATOR

Three capsules post-breakfast Three capsules post-dinner

Other: Placebo

Interventions

Collagen Supplement OTHER

Three capsules post-breakfast Three capsules post-dinner

Collagen Supplement

Glucosamine chondroitin OTHER

Three capsules post-breakfast Three capsules post-dinner

Glucosamine chondroitin

Placebo OTHER

Three capsules post-breakfast Three capsules post-dinner

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (5)

Dr. Randive's knee and spine clinic

Mumbai, Maharashtra, 400093, India

Location

PKC Hospital

Mumbai, Maharashtra, 400705, India

Location

Dr Sonawane orthopedic clinic

Mumbai, Maharashtra, 400709, India

Location

Rainbow Multispeciality hospital and trauma center

Navi Mumbai, Maharashtra, 400708, India

Location

Shubham Sudbhawana Super Specialty Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (1)

• Luo C, Su W, Song Y, Srivastava S. Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double-blind, placebo-controlled trial. J Exp Orthop. 2022 Dec 23;9(1):123. doi: 10.1186/s40634-022-00559-8.

  PMID: 36562843 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dr. Shalini Srivastava, MD - Med.

  Vedic Life Sciences Pvt. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 14, 2020
• Study Start: July 9, 2020
• Primary Completion: February 24, 2021
• Study Completion: April 12, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-03

Locations

IN (5)