Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects

A Randomized, Double-Blind, Placebo-controlled, Parallel Design Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects

A Randomized, Double-Blind, Placebo-controlled, Parallel Design Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects

Study Overview

• Status: Recruiting
• Conditions: Joint Pain
• Intervention / Treatment: Drug: Collagen type II (40 mg/day); Drug: Collagen type II (80mg/day); Drug: Collagen type II (120 mg/day); Drug: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shalini srivastava, MD - Medicine; Phone Number: 02242172300; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Dr. Sonali Ghosh, BAMS; Phone Number: 02242172300; Email: sonali.g@vediclifesciences.com

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006.
      • Not yet recruiting
      • HOS Hospital
      • Contact: Dr. Shabbir Sabuwala, MS ortho; Phone Number: 9712940025; Email: drsksabuwala@gmail.com
      • Principal Investigator: Dr. Shabbir Sabuwala, MS ortho
    • Sūrat, Gujarat, India, 395009.
      • Recruiting
      • Shalby Hospital
      • Contact: Dr. Kush Vyas, MBBS D ORTHO; Email: clinicalresearch3.surat@shalby.in
      • Principal Investigator: Dr. Kush Vyas, MBBS D ORTHO
    • Vadodara, Gujarat, India, 390021
      • Recruiting
      • Aman Hospital and Research Centre
      • Contact: Dr. Aman Khanna, MBBS; Phone Number: 9904402122; Email: amankhanna1974@gmail.com
      • Principal Investigator: Dr. Aman Khanna, MBBS
  • Karnataka
    • Bijapur, Karnataka, India, 586101
      • Not yet recruiting
      • BLDEU Hospital and research center
      • Contact: Dr Shreepad Kulkarni, D ortho; Phone Number: 9964670630; Email: orthoshree@gmail.com
      • Principal Investigator: Dr Shreepad Kulkarni, D ortho
  • Maharashtra
    • Dombivli, Maharashtra, India, 421201
      • Recruiting
      • Shree Ashirwad Hospital
      • Contact: Dr Shailesh Talele, MBBS; Phone Number: 9820809180; Email: shaileshtalele@yahoo.co.in
      • Principal Investigator: Dr Shailesh Talele, MBBS
    • Nashik, Maharashtra, India, 400003.
      • Recruiting
      • Surya Hospital
      • Contact: Dr Rohit Sonawane, MBBS; Phone Number: 9225109679; Email: srgnosteon@gmail.com
      • Principal Investigator: Dr Rohit Sonawane, MBBS
    • Pune, Maharashtra, India, 411037
      • Recruiting
      • Ranka Hospital
      • Contact: Dr Ramesh Ranka, MBBS; Phone Number: 9823049074; Email: ramesh.ranka@yahoo.co.in
      • Principal Investigator: Dr Ramesh Ranka, MBBS
    • Pune, Maharashtra, India, 412101
      • Recruiting
      • Jivanrekha Hospital
      • Contact: Dr Ajay Dombale, MBBS; Phone Number: 7741810820; Email: drajay9582@gmail.com
      • Principal Investigator: Dr Ajay Dombale, MBBS
    • Thāne, Maharashtra, India, 400053
      • Recruiting
      • BAJ RR Hospital
      • Contact: Dr Prashant Deshpande, M B B S; Phone Number: 9167432672; Email: drprashantd1981@yahoo.com
      • Principal Investigator: Dr Prashant Deshpande, M B B S
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Recruiting
      • Jaipur National University Institute of Medical Sciences and Research Center
      • Contact: Dr. Ankesh Goyal, DNB ortho; Phone Number: 7060924809; Email: clinicalresearch@jnujaipur.ac.in
      • Principal Investigator: Dr. Ankesh Goyal, DNB ortho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Physically active male and female both, aged ≥ 20 to ≤ 65 years with the daily routine of physical exercise (exercise such as walking, jogging, running, cycling, climbing stairs, squatting or any other exercise on investigator's discretion that involves knee joint movement) for at least 3 days a week.
2. Subject with a history of 4-9 months related to knee joint pain aggravation on physical stress.
3. Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
4. Fasting blood glucose (FBG) ≤ 125 mg/ dl.
5. Subject with self-reported joint pain of ≥ 70 mm on a 100-point VAS scale after 10±2 minutes of walking on a treadmill using modified Naughton protocol.
6. Subject with pain ≤30 mm at rest on Pain VAS
7. Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria.
8. The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
9. The subject is willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
10. Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.

Exclusion Criteria:

1. Obese Subject with BMI > 29.9 kg/m2.
2. Subject's inability to complete the exercise protocol of 10±2 minutes at screening.
3. Subject with the clinical diagnosis of any form of joint disease such as Osteoarthritis (OA).
4. Subject with the clinical diagnosis of any form of autoimmune disorder related to the joint such as Rheumatoid arthritis (RA).
5. A subject suffering from Insomnia and restless leg syndrome.
6. Uncontrolled hypertensive defined as subject currently on an anti-hypertensive drug with systolic Blood Pressure ≥ 140 mm Hg and/ or & diastolic blood pressure ≥ 90 mm Hg
7. Uncontrolled diabetics currently on anti-diabetic medication with Fasting blood glucose (FBG) ≥ 126 mg/ dl.
8. Systolic Blood Pressure ≥ 140 mm Hg and/ or & diastolic blood pressure ≥ 90 mm Hg
9. The subject who have been injured near the knee joint region in the past six months.
10. Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes.
11. The subject who have used Intra-articular injections and or steroids for joint health issues in the last six months. The subjects who have undergone a significant cardiovascular event in the past six months.
12. The subject who has undergone a significant cardiovascular event in the past six months.
13. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
14. The subject who have any other chronic disease or condition or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the subject at unacceptable risk the for the subject in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
15. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
16. The subject who have participated in a study of an investigational product 90 days prior to the screening.
17. Subject with a history of heavy alcohol consumption.
18. Smokers
19. Subject currently on joint health supplements for pain or inflammation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Collagen type II (40 mg/day); 4 capsules per day for 180 days	Drug: Collagen type II (40 mg/day); 4 capsules per day
EXPERIMENTAL: Collagen type II (80 mg/day); 4 capsules per day for 180 days	Drug: Collagen type II (80mg/day); 4 capsules per day
EXPERIMENTAL: Collagen type II (120 mg/day); 4 capsules per day for 180 days	Drug: Collagen type II (120 mg/day); 4 capsules per day
ACTIVE_COMPARATOR: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg); 4 capsules per day for 180 days	Drug: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg); 4 capsules per day
PLACEBO_COMPARATOR: Placebo; 4 capsules per day for 180 days	Drug: Placebo; 4 capsules per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion (active flexion and extension)	To evaluate the efficacy of collagen on knee joint flexibility as assessed by the change in the range of motion (active flexion and extension) using goniometry as compared to placebo.	from baseline Day 0 to end of study visit day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion knee joint flexibility	Change in the knee joint flexibility (Knee ROM Extension) as assessed by a range of motion (using goniometry) in the Collagen groups versus the other groups	from baseline (day 0) to end of study visit (day 180)
Pain visual analog scale	Knee joint pain as assessed by Pain visual analog scale at the end of the stress exercise in Collagen groups versus the placebo and the Glucosamine & Chondroitin group. 0 - No pain at all 100 - worst possible pain	from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180
Knee injury and Osteoarthritis Outcome Score	Retrospective Joint Discomfort as assessed by the change in the Knee injury and Osteoarthritis Outcome Score as compared in the Collagen groups compared to placebo and Glucosamine & Chondroitin. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0- 100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures. Scores between 0 and 100 represent the percentage of the total possible score achieved	from baseline (Day 0) (post-exercise) to follow up visit Day 5, 30, 60, 90, 120, 150 and day 180 (post-exercise)
European Quality of Life Five Dimension five-level	Quality of life (QoL) as assessed by change in European Quality of Life Five Dimension five-level score as compared to the change into placebo and Glucosamine & Chondroitin groups Lower level is denoted as 1 and the highest level is denoted as 5	from baseline (Day 0) to the end of the study (day 180)

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2022
• Primary Completion (ANTICIPATED): September 15, 2023
• Study Completion (ANTICIPATED): September 15, 2023

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: LZ/210901/UCII/RMJD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No