Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Group A: PVD 02 (Boswellia serrata extract capsules (300 mg)): Group A: One PVD 02 capsule twice a day for 90 days.
Intervention2: PVD 06 (Boswellia serrata (300 mg) plus Apium graveole
Sponsors
Phytoveda Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex with age 40 to 65 years (both inclusive) with a BMI not more than 30.00 kg/m2;2.Confirmed diagnosis of knee osteoarthritis as per clinical American College of Rheumatology (ACR) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age >50 years, morning stiffness 4 on walking in one or both knees during the 24 hrs. preceding recruitment; 4.Patient ambulant and requiring treatment with an anti ?inflammatory drug and not receiving regular anti ?inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change;5.Patients taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention. 6.Patients willing to come for regular follow ?up visits; 7.Participants can walk and give both verbal and written information regarding the study.
Exclusion criteria
Exclusion criteria: 1.Known history of hypersensitivity to herbal extracts or dietary supplements; 2.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, 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.Patients incapacitated or bound to a wheelchair or bed and unable to carry out self-care activities; 5.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine; 6.Evidence of several renal, hepatic, or hematopoietic diseases or severe cardiac insufficiency as revealed by laboratory investigations; 7.Patient with congestive heart failure; 8.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 3 months; 9.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months; 10.Indication of surgery for OA knee; 11.Arthroscopy of either knee in the past year; 12.Any condition that in the opinion of the investigator does not justify the patient’s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in WOMAC A, B, & C subscale scores for pain, stiffness, & physical disability at screening, day 7, day 15, day 30, day 45, day 60, & day 90. -WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, -WOMAC- B for levels of stiffness & -WOMAC-C for levels of physical disability 2.Changes in physician’s global assessment for pain at screening, day 1, day 3, day 7, day 15, day 30, day 45, day 60, & day 90. 3.Changes in distance covered in the six ?minute walk test at day 0, day 7, day 15, day 30, day 45, day 60, & day 90 4.Changes in VAS pain scale score at screening, day 1, day 3, day 7, day 15,day 30, day 45, day 60, day 90, day 105 and day 120 5.Changes in radiological examination (X-ray) only for patients as per the discretion of the investigator – day 0 and day 90Timepoint: From screening Visit to end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in biomarkers such as PIIANP, Human Procollagen 2 C-terminal Peptide, Cartilage Oligomeric Matrix Protein, C-Telopeptide of type II collagen (CTX-II), TNF-Alpha, IL-1, IL-6, IL-7, hsCRP, MMPs (MMP 3) at screening & day 90. 2. Changes in requirement of analgesic as a rescue medication at screening, day 30, day 60, & day 90. 3. Changes in gastrointestinal symptoms like heartburn, gastric discomfort, & epigastric pain on the 4-point Linkert scale at screening, day 7, day 15, day 30, day 45, day 60, and day 90. 4. Changes in KOOS scoring for quality of life at day 0 and day 90. 5. Changes in FACIT-F score at day 0 and day 90. 6. Changes in symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth at screening, day 1, day 3, day 7, day 15, day 30, day 45, day 60, and day 90.Timepoint: From screening Visit to end of the study. | — |
Countries
India
Contacts
Public ContactMr Anirudh Mehta
Phytoveda Pvt. Ltd
Outcome results
None listed