Health Condition 1: M129- Arthropathy, unspecified
Conditions
Interventions
Intervention1: 20% Turmeric Extract: Capsule containing 500mg Curcumin derivative twice a day after breakfast and dinner for 90 days
Control Intervention1: Microcrystalline cellulose: Capsule containi
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participants whose age =30 and = 65 years. 2. Participants must provide a written and signed informed consent and comply with requirements of the study. 3. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol. 4. HsCRP level = 3mg/L. 5. Patient with mild to moderate pain in knees. 6. Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications. 7. Patients with the pain perception ranging from 30 to 60 based on VAS (Visual Analog Scale) of 0 – 100mm.
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection. 2. Patients with a history of knee or hip replacement surgery. 3. Treatment of knee joint pain with intra-articular injection of corticosteroids within the last 3 months preceding study. 4. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor. 5. Patient with history of Asthma or on medication with Ipratropium Bromide. 6. Patients undergoing treatment for any other systemic illness. 7. Medication: i. Participants who have used the following substances within 1 week prior to screening – glucosamine sulfate, chondroitin sulfate, NSAID, glucocorticoids, or steroids. ii. Participant who have used hyaluronate within a month prior to screening. iii. Participants who have used any of the below dietary supplements within the past 30 days – Boswellia, Omega3, Collagen, Curcumin etc 8. Pregnant, Lactating Women & women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study. 9. History of chronic smoking and Alcoholics. 10. Those who have participated in any other clinical trial within the last 3 months from the date of visit 1 or who plan to participate in any other study during the clinical trial period. 11. Any other condition/reason which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean change in KOOS score 2 Mean change in VAS Pain ScaleTimepoint: 1 Randomisation Day to Day 90 2 Screening Day to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Mean change in the HsCRP 2 Mean change in IL-6 3 Mean change in ESR 4 Mean change in KOOS Score for pain, stiffness & function subscale during the study 5 Mean change in the range of movement by Goniometer 6 Safety as determined through changes in lab test results and incidence of adverse events during the study period in both armsTimepoint: 1 Screening Day to Day 90 2 Randomisation Day and Day 90 3 Screening Day and Day 90 4 Randomisation Day to Day 90 5 Screening Day to Day 90 6 Screening Day to Day 90 and telephonic follow up | — |
Countries
India
Contacts
Public ContactSatish G
Sami Sabinsa Group Limited
Outcome results
None listed