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

Last updated: November 29, 2022
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Joint Injuries

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT05212259
LZ/210901/UCII/RMJD
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Physically active male and female both, aged ≥ 20 to ≤ 65 years with the daily routineof physical exercise (exercise such as walking, jogging, running, cycling, climbingstairs, squatting or any other exercise on investigator's discretion that involvesknee joint movement) for at least 3 days a week.
  2. Subject with a history of 4-9 months related to knee joint pain aggravation onphysical 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±2minutes 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 ofrheumatology (ACR) criteria.
  8. The subject is willing to complete all the study procedures including study-relatedquestionnaires and tasks, and comply with the study requirements.
  9. The subject is willing to abstain from the restricted supplements and medicationsprior to inclusion and throughout the study period.
  10. Subject with the ability to read and provide written, personally signed, and datedinformed consent to participate in the study.

Exclusion

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 asOsteoarthritis (OA).
  4. Subject with the clinical diagnosis of any form of autoimmune disorder related to thejoint 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 drugwith systolic Blood Pressure ≥ 140 mm Hg and/ or & diastolic blood pressure ≥ 90 mm Hg
  7. Uncontrolled diabetics currently on anti-diabetic medication with Fasting bloodglucose (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 surgicalprocedures that may impact the study outcomes.
  11. The subject who have used Intra-articular injections and or steroids for joint healthissues in the last six months. The subjects who have undergone a significantcardiovascular event in the past six months.
  12. The subject who has undergone a significant cardiovascular event in the past sixmonths.
  13. History or presence of clinically significant renal, hepatic, endocrine, biliary,gastrointestinal, pancreatic, or neurological disorders, that in the judgment of theInvestigator, would interfere with the subject's ability to provide informed consent,comply with the study protocol (which might confound the interpretation of the studyresults), or put the subject at undue risk.
  14. The subject who have any other chronic disease or condition or inflammatory diseaseconditions and/ or are using any medication or dietary supplements or ayurvedicmedications or topical ointment/oil/gel for joint health that in the judgment of theInvestigator would put the subject at unacceptable risk the for the subject in thestudy or may interfere with evaluations in the study or noncompliance with treatmentor visits.
  15. Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.
  16. The subject who have participated in a study of an investigational product 90 daysprior 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 Design

Total Participants: 375
Study Start date:
October 10, 2022
Estimated Completion Date:
September 15, 2023

Connect with a study center

  • HOS Hospital

    Ahmedabad, Gujarat 380006.
    India

    Site Not Available

  • Shalby hospital

    Sūrat, Gujarat 395009.
    India

    Active - Recruiting

  • Aman Hospital and Research Centre

    Vadodara, Gujarat 390021
    India

    Active - Recruiting

  • BLDEU Hospital and research center

    Bijapur, Karnataka 586101
    India

    Site Not Available

  • Shree Ashirwad Hospital

    Dombivli, Maharashtra 421201
    India

    Active - Recruiting

  • Surya Hospital

    Nashik, Maharashtra 400003.
    India

    Active - Recruiting

  • Jivanrekha Hospital

    Pune, Maharashtra 412101
    India

    Active - Recruiting

  • Ranka Hospital

    Pune, Maharashtra 411037
    India

    Active - Recruiting

  • BAJ RR Hospital

    Thāne, Maharashtra 400053
    India

    Active - Recruiting

  • Jaipur National University Institute of Medical Sciences and Research Center

    Jaipur, Rajasthan 302017
    India

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.