Clinical study of nutritional formulations in the management of knee osteoarthritis.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2024/07/070163
- Lead Sponsor
- ife Synergy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 greater than 50 years, morning stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth; 3.Patients with a minimum pain visual analog scale (VAS) score greater than 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Changes in WOMAC A, B, and C subscale scores for pain, stiffness, and physical disability <br/ ><br>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, <br/ ><br>WOMAC- B for levels of stiffness and <br/ ><br>WOMAC-C for levels of physical disability <br/ ><br>2.Changes in VAS pain scale score.Timepoint: From Screening to the end of the study.
- Secondary Outcome Measures
Name Time Method 1.Changes in biomarkers such as PIIANP, Human Procollagen 2 C-terminal Peptide, COMP, Urinary C-Telopeptide of type II collagen (CTX-II), TNF-Alpha, IL-6, hs-CRP, MMP 3. <br/ ><br>2.Changes in requirement of analgesic as a rescue medication. <br/ ><br>3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, and epigastric pain on the 4-point Linkert scale. <br/ ><br>4.Changes in KOOS scoring for quality of life. <br/ ><br>5.Changes in symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth. <br/ ><br>6.Changes in distance covered in the six ?minute walk test <br/ ><br>Timepoint: From Screening to the end of the study.