Health Condition 1: M129- Arthropathy, unspecified
Conditions
Interventions
Intervention1: C3 Reduct: It is combination of curcumin derivatives of 70 mg capsule to be administered twice a day after breakfast and dinner for 90 days.
Control Intervention1: Placebo: Capsule cont
Sponsors
Sam Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participants whose age â?¥18 and â?¤ 60 years. 2. Participants should provide a written and signed informed consent and comply with requirements of the study. 3. HsCRP level should be equal or more than 3 mg/dl. 4. Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications. 5. Patients with the pain perception ranging from 30 to 100 when measuring VAS (Visual Analog Scale) of 0- 100mm. 6. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infections. 2. Patients with history of knee and hip replacement surgery. 3. Treatment of knee joint pain with intra-articular injections of corticosteroids within last 3 months preceding study. 4. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour. 5. Patients with history of asthma or on medication with Ipratropium Bromide. 6. Patients undergoing treatment for any systemic illness. 7. Pregnant, lactating women or women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study. 8. History of chronic smoking and alcoholics. 9. Those who have participated in any other clinical trial within the last 3months from the date of first visit. 10. Any other condition/ reason which the principal investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale. 2. Mean change in the VASTimepoint: 1. Mean change in the KOOS & modified WOMAC score for pain, stiffness and function sub-scale from day-1 to day 90. 2. Mean change in the VAS from screening to day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in the HsCRP, IL-6 & ESR. 2. Mean change in the range of Movement by Goniometer. 3. Safety as determined through changes in the lab results and incidence of adverse events during the study period in both arms.Timepoint: 1. Screening to Day-90 2. Screening to Day-90 3. Screening to Day-90 | — |
Countries
India
Contacts
Public ContactSatish G
Sami Sabinsa Group Limited
Outcome results
None listed