Joint PainNCT05212259
Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects
A study testing Collagen type II (40 mg/day), Collagen type II (80mg/day) and Collagen type II (120 mg/day) in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 10 sites in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain
- What is being tested?
- Collagen type II (40 mg/day), Collagen type II (80mg/day) and Collagen type II (120 mg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 10 sitesIndia
- Study dates
- 10 Oct 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- The subject is willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
- Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Who cannot join
- 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
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- 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.
- The subject who have participated in a study of an investigational product 90 days prior to the screening.
- Subject with a history of heavy alcohol consumption.
- Smokers
- Subject currently on joint health supplements for pain or inflammation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites, 10 recruiting
- Not yet recruiting
HOS Hospital
Ahmedabad, Gujarat, 380006.
Dr. Shabbir Sabuwala, MS ortho, 9712940025, drsksabuwala@gmail.com
Dr. Shabbir Sabuwala, MS ortho
- Recruiting
Shree Ashirwad Hospital
Dombivali, Maharashtra, 421201
Dr Shailesh Talele, MBBS, 9820809180, shaileshtalele@yahoo.co.in
Dr Shailesh Talele, MBBS
- Recruiting
Jaipur National University Institute of Medical Sciences and Research Center
Jaipur, Rajasthan, 302017
Dr. Ankesh Goyal, DNB ortho, 7060924809, clinicalresearch@jnujaipur.ac.in
Dr. Ankesh Goyal, DNB ortho
- Recruiting
Surya Hospital
Nashik, Maharashtra, 400003.
Dr Rohit Sonawane, MBBS, 9225109679, srgnosteon@gmail.com
Dr Rohit Sonawane, MBBS
- Recruiting
Ranka Hospital
Pune, Maharashtra, 411037
Dr Ramesh Ranka, MBBS, 9823049074, ramesh.ranka@yahoo.co.in
Dr Ramesh Ranka, MBBS
- Recruiting
Jivanrekha Hospital
Pune, Maharashtra, 412101
Dr Ajay Dombale, MBBS, 7741810820, drajay9582@gmail.com
Dr Ajay Dombale, MBBS
- Recruiting
Shalby hospital
Surat, Gujarat, 395009.
Dr. Kush Vyas, MBBS D ORTHO, clinicalresearch3.surat@shalby.in
Dr. Kush Vyas, MBBS D ORTHO
- Recruiting
BAJ RR Hospital
Thane, Maharashtra, 400053
Dr Prashant Deshpande, M B B S, 9167432672, drprashantd1981@yahoo.com
Dr Prashant Deshpande, M B B S
- Recruiting
Aman Hospital and Research Centre
Vadodara, Gujarat, 390021
Dr. Aman Khanna, MBBS, 9904402122, amankhanna1974@gmail.com
Dr. Aman Khanna, MBBS
- Not yet recruiting
BLDEU Hospital and research center
Vijayapura, Karnataka, 586101
Dr Shreepad Kulkarni, D ortho, 9964670630, orthoshree@gmail.com
Dr Shreepad Kulkarni, D ortho
About this study
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
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
- Conditions
- Joint Pain
- Being tested
- Collagen type II (40 mg/day), Collagen type II (80mg/day), Collagen type II (120 mg/day), Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg), Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen type II (40 mg/day)Drug
4 capsules per day
Collagen type II (80mg/day)Drug
4 capsules per day
Collagen type II (120 mg/day)Drug
4 capsules per day
Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)Drug
4 capsules per day
PlaceboDrug
4 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Collagen type II (40 mg/day) | Experimental | 4 capsules per day for 180 days Receives: Drug: Collagen type II (40 mg/day) |
| Collagen type II (80 mg/day) | Experimental | 4 capsules per day for 180 days Receives: Drug: Collagen type II (80mg/day) |
| Collagen type II (120 mg/day) | Experimental | 4 capsules per day for 180 days Receives: Drug: Collagen type II (120 mg/day) |
| Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg) | Active comparator | 4 capsules per day for 180 days Receives: Drug: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg) |
| Placebo | Placebo comparator | 4 capsules per day for 180 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline Day 0 to end of study visit day 180
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: from baseline (Day 0) to the end of the study (day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 Oct 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-controlled, Parallel Design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212259
- Sponsor's protocol ID
- LZ/210901/UCII/RMJD
- Status last verified
- Nov 2022
- First submitted
- 14 Jan 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05212259
- Acronym / sponsor ID
- LZ/210901/UCII/RMJD
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Randomized, Double-Blind, Placebo-controlled, Parallel Design
| Arm | Type | Receives |
|---|---|---|
| Collagen type II (40 mg/day) | Experimental | Drug: Collagen type II (40 mg/day)4 capsules per day for 180 days |
| Collagen type II (80 mg/day) | Experimental | Drug: Collagen type II (80mg/day)4 capsules per day for 180 days |
| Collagen type II (120 mg/day) | Experimental | Drug: Collagen type II (120 mg/day)4 capsules per day for 180 days |
| Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg) | Active comparator | Drug: Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)4 capsules per day for 180 days |
| Placebo | Placebo comparator | Drug: Placebo4 capsules per day for 180 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen type II (40 mg/day)4 capsules per day | Drug | Collagen type II (40 mg/day) |
| Collagen type II (80mg/day)4 capsules per day | Drug | Collagen type II (80 mg/day) |
| Collagen type II (120 mg/day)4 capsules per day | Drug | Collagen type II (120 mg/day) |
| Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg)4 capsules per day | Drug | Glucosamine Hydrochloride with Chondroitin Sulphate (2700 mg) |
| Placebo4 capsules per day | Drug | Placebo |
Primary outcome
range of motion (active flexion and extension)
Time frame: from baseline Day 0 to end of study visit day 180
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.
4 secondary outcomes
range of motion knee joint flexibility
Time frame: from baseline (day 0) to end of study visit (day 180)
Pain visual analog scale
Time frame: from baseline (Day 0) to Day 5, 30, 60, 90, 120, 150 and 180
Knee injury and Osteoarthritis Outcome Score
Time frame: 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
Time frame: from baseline (Day 0) to the end of the study (day 180)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen type II (40 mg/day), Collagen type II (80mg/day) and Collagen type II (120 mg/day) in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shalini srivastava, MD - Medicine (02242172300, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (active flexion and extension) (time frame: from baseline Day 0 to end of study visit day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.