Health Condition 1: M15-M19- Osteoarthritis
Conditions
Interventions
Intervention1: Boswellin® Super
: 150 mg (Boswellin Super 150mg + MCC 150mg) twice a day along with food for 90 Days
Intervention2: Boswellin® Super: 300 mg (Boswellin Super 300mg) twice a day along
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either sex, 40 to 75 years of age. 2. Participants newly diagnosed with degenerative hypertrophy OA (imaging diagnosis) 3. Participants whose knee KL (Kellgren-Lawrence) grade is I-II. 4. Participant with the pain perception ranging from 30 to 100 when measuring VAS (Visual Analog Scale) of 0 â?? 100mm. 5. Willing to come for regular follow -up visits. 6. Able to give written informed consent and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity to herbal extracts or dietary supplements. 2. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test. 3. Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection). 4. Participant with moderate or severe synovitis: KL (Kellgren-Lawrence) grade III or higher. 5. Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities. 6. Participant with a history of knee or hip replacement surgery. 7. Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study. 8. Pre-existing or recent onset of demyelinating disorders. 9. Participants with a ruptured meniscus. 10. Evidence of several renal, hepatic, or hemopoietic diseases or severe cardiac insufficiency as revealed by laboratory investigations. 11. Participant with chronic diseases of kidney, liver, or gastrointestinal tract, cardiovascular, endocrine, or nervous system. 12. Participants with uncontrolled hypertension and uncontrolled diabetes. 13. Clinically significant untreated hyperlipidaemia in context of a cardiovascular risk. 14. Medication: ï?· Drug addiction ï?· Participants who have used the following substance within 1 week prior to screening â?? glucosamine sulfate, chondroitin sulfate, NSAID, glucocorticoids, or steroids. ï?· Participant who has used hyaluronate within a month prior to screening. ï?· Participants who have used the below dietary supplement within the past 30 day â?? Boswellia, Omega3, Collagen, Curcumin etc. 15. History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing. 16. Lifestyle: ï?· Alcoholics (inability to control drinking due to both physical and emotional dependence on alcohol characterized by uncontrolled drinking and preoccupation with alcohol) ï?· History of chronic smoking (more than 2 cigarettes a day) 17. Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Boswellin® Super in managing the painful Osteoarthritis of Knee in study participants Primary Endpoints: 1. Mean change in modified WOMAC â?? Total score (Day 0, Day 5, Day30, Day 60, and Day 90). 2. Mean change in VAS Pain Scale (Screening, day 5, day30, day 60 and day 90)Timepoint: 1. Day 0, Day 5, Day30, Day 60, and Day 90. 2. Screening, day 5, day30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Boswellin® Super along with other efficacy parameters associated with OA in comparison to Placebo. 1. Safety assessment through change in vital sign, physical examination,adverse event. 2. Safety assessment through laboratory tests. 3. Mean change in modified WOMAC - pain subscale 4. Mean change in modified WOMAC - stiffness subscale 5. Mean change in modified WOMAC - function subscale 6. Mean change in Distance walked in 6 minutes 7. Mean Change in Lequesne Functional Index (LFI). 8. Mean change in European Q5D Quality of Life 9. Mean Change in Biomarker ( hs-CRP, ESR, TNF-alpha, and IL-6) 10. Mean change in physicianâ??s global assessment.Timepoint: 1.Day 0, day 5, day 30, day 60, day 90 and day 105 2. Day 0, day 5, day 30, day 60 and day 90 3. Day 0, day 5, day 30,day 60 and day 90 4. Day 0, day 5, day 30, day 60 and day 90 5. Day 0, day5, day 30, day 60 and day 90 6. Day 0, day 5, day 30, day 60 and day 90 7. Day 0, day 5, day 30, day 60 and day 90 8. Day 0, day 5, day 30, day 60, day 90 and day 105 9. Day 0 and day 90 10. Screening, Day 5, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactShaji Paulose
Sami-Sabinsa Group Ltd
Outcome results
None listed