Phase
Condition
Arthritis And Arthritic Pain
Joint Injuries
Rheumatoid Arthritis
Treatment
N/AClinical Study ID
Ages 20-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- Subject with a history of 4-9 months related to knee joint pain aggravation onphysical 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±2minutes 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 ofrheumatology (ACR) criteria.
- The subject is willing to complete all the study procedures including study-relatedquestionnaires and tasks, and comply with the study requirements.
- The subject is willing to abstain from the restricted supplements and medicationsprior to inclusion and throughout the study period.
- Subject with the ability to read and provide written, personally signed, and datedinformed consent to participate in the study.
Exclusion
Exclusion Criteria:
- 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 asOsteoarthritis (OA).
- Subject with the clinical diagnosis of any form of autoimmune disorder related to thejoint such as Rheumatoid arthritis (RA).
- A subject suffering from Insomnia and restless leg syndrome.
- 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
- Uncontrolled diabetics currently on anti-diabetic medication with Fasting bloodglucose (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 surgicalprocedures that may impact the study outcomes.
- 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.
- The subject who has undergone a significant cardiovascular event in the past sixmonths.
- 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.
- 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.
- Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.
- The subject who have participated in a study of an investigational product 90 daysprior to the screening.
- Subject with a history of heavy alcohol consumption.
- Smokers
- Subject currently on joint health supplements for pain or inflammation.
Study Design
Connect with a study center
HOS Hospital
Ahmedabad, Gujarat 380006.
IndiaSite Not Available
Shalby hospital
Sūrat, Gujarat 395009.
IndiaActive - Recruiting
Aman Hospital and Research Centre
Vadodara, Gujarat 390021
IndiaActive - Recruiting
BLDEU Hospital and research center
Bijapur, Karnataka 586101
IndiaSite Not Available
Shree Ashirwad Hospital
Dombivli, Maharashtra 421201
IndiaActive - Recruiting
Surya Hospital
Nashik, Maharashtra 400003.
IndiaActive - Recruiting
Jivanrekha Hospital
Pune, Maharashtra 412101
IndiaActive - Recruiting
Ranka Hospital
Pune, Maharashtra 411037
IndiaActive - Recruiting
BAJ RR Hospital
Thāne, Maharashtra 400053
IndiaActive - Recruiting
Jaipur National University Institute of Medical Sciences and Research Center
Jaipur, Rajasthan 302017
IndiaActive - Recruiting

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