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
1 other identifier
interventional
375
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedNovember 30, 2022
November 1, 2022
11 months
January 14, 2022
November 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
range of motion knee joint flexibility
from baseline (day 0) to end of study visit (day 180)
Pain visual analog scale
from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180
Knee injury and Osteoarthritis Outcome Score
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
from baseline (Day 0) to the end of the study (day 180)
Study Arms (5)
Collagen type II (40 mg/day)
EXPERIMENTAL4 capsules per day for 180 days
Collagen type II (80 mg/day)
EXPERIMENTAL4 capsules per day for 180 days
Collagen type II (120 mg/day)
EXPERIMENTAL4 capsules per day for 180 days
Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)
ACTIVE COMPARATOR4 capsules per day for 180 days
Placebo
PLACEBO COMPARATOR4 capsules per day for 180 days
Interventions
4 capsules per day
Eligibility Criteria
You may qualify if:
- 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.
- Subject with a history of 4-9 months related to knee joint pain aggravation on physical stress.
- Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Fasting blood glucose (FBG) ≤ 125 mg/ dl.
- 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.
- Subject with pain ≤30 mm at rest on Pain VAS
- Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria.
- The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
- Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
You may not qualify if:
- Obese Subject with BMI \> 29.9 kg/m2.
- Subject's inability to complete the exercise protocol of 10±2 minutes at screening.
- Subject with the clinical diagnosis of any form of joint disease such as Osteoarthritis (OA).
- Subject with the clinical diagnosis of any form of autoimmune disorder related to the joint such as Rheumatoid arthritis (RA).
- A subject suffering from Insomnia and restless leg syndrome.
- 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
- Uncontrolled diabetics currently on anti-diabetic medication with Fasting blood glucose (FBG) ≥ 126 mg/ dl.
- Systolic Blood Pressure ≥ 140 mm Hg and/ or \& diastolic blood pressure ≥ 90 mm Hg
- The subject who have been injured near the knee joint region in the past six months.
- Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes.
- 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.
- The subject who has undergone a significant cardiovascular event in the past six months.
- 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.
- 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.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
HOS Hospital
Ahmedabad, Gujarat, 380006., India
Shalby hospital
Surat, Gujarat, 395009., India
Aman Hospital and Research Centre
Vadodara, Gujarat, 390021, India
BLDEU Hospital and research center
Vijayapura, Karnataka, 586101, India
Shree Ashirwad Hospital
Dombivali, Maharashtra, 421201, India
Surya Hospital
Nashik, Maharashtra, 400003., India
Ranka Hospital
Pune, Maharashtra, 411037, India
Jivanrekha Hospital
Pune, Maharashtra, 412101, India
BAJ RR Hospital
Thane, Maharashtra, 400053, India
Jaipur National University Institute of Medical Sciences and Research Center
Jaipur, Rajasthan, 302017, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Envelope blinding chits
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 28, 2022
Study Start
October 10, 2022
Primary Completion
September 15, 2023
Study Completion
September 15, 2023
Last Updated
November 30, 2022
Record last verified: 2022-11