Clinical trial NCT05212259: Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Pain
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 375
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-controlled, Parallel Design
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: range of motion (active flexion and extension)
timeFrame: from baseline Day 0 to end of study visit day 180
Secondary outcomes:
measure: range of motion knee joint flexibility
timeFrame: from baseline (day 0) to end of study visit (day 180)
measure: Pain visual analog scale
timeFrame: from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: from baseline (Day 0) (post-exercise) to follow up visit Day 5, 30, 60, 90, 120, 150 and day 180 (post-exercise)
measure: European Quality of Life Five Dimension five-level
timeFrame: from baseline (Day 0) to the end of the study (day 180)
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: HOS Hospital
state: Gujarat
city: Sūrat
country: India
facility: Shalby hospital
state: Gujarat
city: Vadodara
country: India
facility: Aman Hospital and Research Centre
state: Gujarat
city: Bijapur
country: India
facility: BLDEU Hospital and research center
state: Karnataka
city: Dombivli
country: India
facility: Shree Ashirwad Hospital
state: Maharashtra
city: Nashik
country: India
facility: Surya Hospital
state: Maharashtra
city: Pune
country: India
facility: Ranka Hospital
state: Maharashtra
city: Pune
country: India
facility: Jivanrekha Hospital
state: Maharashtra
city: Thāne
country: India
facility: BAJ RR Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Jaipur National University Institute of Medical Sciences and Research Center
state: Rajasthan
Study officials:
References: