None listed
Conditions
Interventions
Intervention1: Acujoint® 250 mg: 1 capsule in a day for 180 days.
Intervention2: Acujoint® 175 mg: 1 capsule in a day for 180 days.
Control Intervention1: Placebo: 1 capsule in a day for 180 days.
Sponsors
Aurea Biolabs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Physically active male and female both, aged greater than or equal to 30 to less than or equal 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 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. (Kellgren-Lawrence (KL) Score 0 to 2). 3) Body mass index (BMI) greater than or equal to 20 and less than or equal to 35 kg/m2. 4) Subject with self-reported joint pain of greater than or equal to 70 mm on a 100-point VAS scale during extreme knee joint movement. 5) Subject with pain less than or equal to 30 mm at rest on Pain VAS. 6) Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria. (KL grade of 0 to 2). 7) The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements. 8) The subject is willing to keep and share a record for other analgesics or pain relief drugs, if taken during the study period. 9) Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Obese Subject with BMI > 35 kg/m2. 2) Subject 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). KL score >3. 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 greater than or equal to 140 mm Hg and/ or & diastolic blood pressure greater than or equal to 90 mm Hg. 7) History of asthma, diabetes. 8) The subject who have been injured near the knee joint region in the past six months. 9) Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes. 10) 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. 11) The subject who has undergone a significant cardiovascular event in the past six months. 12) 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 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. 13) 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. 14) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 15) The subject who have participated in a study of an investigational product 90 days prior to the screening. 16) Subject with a history of heavy alcohol consumption. 17) Smokers 18) Subject currently on joint health supplements for pain or inflammation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 2.Change in CBC and blood lipidsTimepoint: 180 days;3.Inflammation as assessed by the change in the IL-6 levelsTimepoint: 180 days;4.Change in exercise-induced cartilage turnover by evaluating the change in Serum cartilage oligomeric matrix protein (COMP) and urinary CTX-II levels.Timepoint: 180 days;5. Use of rescue medication for joint pain relief.Timepoint: 180 days;6.To assess Quality of life and overall health function, as assessed by SF-36.Timepoint: 180 days;7.Physicians Treatment Satisfaction Assessed Using Physicians Global Impression of Change ScaleTimepoint: 180 days;8.Participants Treatment Satisfaction Assessed Using Patients Global Impression of Change Scale.Timepoint: 180 days;1.Change in BP and pulseTimepoint: 180 days | — |
Primary
| Measure | Time frame |
|---|---|
| 1) Measurements of flexibility using range of motion (ROM) goniometry 2) Assessment of knee joint pain WOMAC A (Pain), WOMAC B (Stiffness) and WOMAC C (Physical function) scores. 3) Lequesne Functional Index (compared to baseline) 4) To rate pain using VAS scale. 5) Clinical monitoring of adverse eventTimepoint: 180 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed