Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Celery seed extract capsule: One 250 mg twice daily for 90 days
Control Intervention1: NA: NIL
Sponsors
Phytoveda Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 40 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg/m²; 2.Confirmed diagnosis of knee osteoarthritis as per clinical ACR (American College of Rheumatology) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age more than 50 years old, morning stiffness less than 30 minutes, crepitus on knee motion, bony tenderness, bony enlargement, no palpable warmth; 3.Participants with a minimum pain visual analog scale (VAS) score more than 4 on walking in one or both knees during the 24 hrs. preceding recruitment; 4.Participant 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.Participants 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.Participants 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, and women of child bearing 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.Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities; 5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study; 6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine; 7.Evidence of several renal, hepatic, or hematopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations; 8.Participant with congestive heart failure; 9.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months; 10.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months; 11.Indication of surgery for OA knee; 12.Arthroscopy of either knee in the past year; 13.Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability. •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 and •WOMAC-C for levels of physical disability 2.Physicians Global Assessment for pain. 3.Distance covered in six minute walk test. 4.VAS pain scale score. 5.Radiological examination - X-ray of knee (for participants as per investigators discretion.Timepoint: 1.At baseline, day 15, day 30, day 60, and day 90. 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Biomarkers such as serum 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) and urinary CTX II. 2.Requirement of analgesic as a rescue medication 3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, epigastric pain on 4 point Linkert scale 4.KOOS scoring for quality of life. 5.FACIT-F score. 6.Symptom grading on a 4 point Linkert scale for joint swelling, tenderness, and warmth.Timepoint: 1.At baseline and day 90. 2.At baseline, day 15, day 30, day 60 and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. 4.At baseline and day 90. 5.At baseline and day 90. 6.At baseline, day 15, day 30, day 60 and day 90. | — |
Countries
India
Contacts
Public ContactMr Anirudh Mehta
Phytoveda Pvt. Ltd
Outcome results
None listed