Herbal formulation clinical trial on Joint Health in audults
- Conditions
- Health Condition 1: M244- Recurrent dislocation of joint
- Registration Number
- CTRI/2020/02/023475
- Lead Sponsor
- Botanic Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Ambulatory, male and female subjects of 40â??70 years of age with a Body Mass Index (BMI) of 20 to 29 kg/m2.
2.Subjects with VAS score between 40 and 70 mm.
3.Subjects with Knee osteoarthritis grade II to III of Kellgren and Lawrence assessed based on X-ray.
4.Willing to refrain from use of glucosamine, chondroitin, MSM, DMSO, doxycycline, ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.
5.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
6.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
7.Subjects ready to discontinue the use of supplementations including vitamins, glucosamine + chondroitin, herbals or other topical applications.
8.Agree to participate in the study through a written informed consent.
9.Willing to comply with all the study related activities.
1.Previous injury and or surgery to the knee.
2.Expectation of surgery during the study period.
3.Subjects with uncontrolled Diabetes
4.Subjects suffering from COPD or having history of any respiratory or breathing disorders.
5.Subjects used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
6.Female subjects who are pregnant breast feeding or planning to become pregnantduring the study period.
7.Subjects having known allergy to non steroidal antiinflammatory drugs NSAIDs including aspirin or has a suspected hypersensitivity allergy or sensitivity to herbal products.
8.Have taken any corticosteroid indomethacin within 1 month prior to theenrollment or intra articular treatment injections with corticosteroid or hyaluronic acid within 6 months prior to enrollment.
9.History of congestive heart failure or any vascular conditions.
10.Subjects with HIV Positive status.
11.Evidence or history of clinically significant in the judgment of the Investigator hematological renal, endocrine pulmonary gastrointestinal cardiovascular hepatic neurologic diseases or malignancies hypothyroidism.
12.History of Systemic Lupus Erythematous
13.Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine, marijuana, etc
14.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
15.Participation in any other trials involving investigational or marketed products within 30days prior to the screening visit.
16.Have taken acetaminophen paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any herbal products within 7 days prior to the screening visit
17.History of heart, liver, lung cancer or chronic diseases.
18.Allergies to any ingredient in the investigational products.
19.Any other condition that, in the opinion of the investigator would adversely affect the subjects ability to complete the study or its measures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the efficacy of turmeric in subjects with mild to moderate knee OsteoarthritisTimepoint: Day 0, Day 28 and Day 56
- Secondary Outcome Measures
Name Time Method To study the safety and tolerability of the study supplement by monitoring the vital signs and possibility of adverse events at each follow-up.Timepoint: Day 0 and Day 56