Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Group A: LSOA01 capsules.
: Group A: LSOA01 one capsule twice a day for 90 days.
Intervention2: Group B: LSOA02 capsules.: Group B: LSOA02 one capsule twice a day for 90 days.
Control
Sponsors
Life Synergy
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 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.
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, 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.Changes in VAS pain scale score.Timepoint: From Screening to the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 2.Changes in requirement of analgesic as a rescue medication. 3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, and epigastric pain on the 4-point Linkert scale. 4.Changes in KOOS scoring for quality of life. 5.Changes in symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth. 6.Changes in distance covered in the six ?minute walk test Timepoint: From Screening to the end of the study. | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed