Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: HFPM-01: Subjects will be advised to take HFPM-01 medication in a dose of 1 cap TDS for 90 days
Control Intervention1: Standard of care: Standard of care with NSAID as and when required
Sponsors
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex, 40 to 70 years of age Diagnosis of OA knees, based on typical history, clinical presentation, findings and fulfilling the ACR classification criteria for OA knees, (Patients presenting knee osteoarthritis together with pain at shoulder, back and muscle spasm will be preferred) A minimum pain VAS score > 8 on walking in one or both knees during the 24 hours preceding recruitment Patient with or without receiving regular anti-inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change Willing to come for regular follow up visits. Written Informed Consent from the patient
Exclusion criteria
Exclusion criteria: Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic, fibromyalgia or collagen vascular disease Patients with known history of coagulopathies Osteoarthritis of any other joint except knee Patients with history of major trauma or surgery in the knee joint Patients with uncontrolled diabetes and hypertension Body mass index (BMI) >40 kg/m2. Patients with any severe cardiac, renal and hepatic disease Pregnant and lactating women Patients who participated in any clinical trial within 30 days before enrollment into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of patient on pain VAS scale, WOMAC scale Improvement in SF-36 Health Survey score Symptomatic relief including pain, inflammation, stiffness, swelling, joint flexibility, weight bearing capacity Levels of inflammatory mediators CRP and ESR in blood Proportion of subjects requiring analgesics as rescue medication Gastrointestinal symptoms due to treatment like stomach pain, heartburn, vomiting, nausea, constipation/ diarrhea etc.Timepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of study drug by assessing adverse events, serious adverse events during the study period. Pain status and improvement in symptoms for other than knee pain if any (Shoulder, back ache and muscle spasms) Vital signs like pulse, BP during the study period Safety parameters including CBC, LFT, KFT, Urine routine and UPT. Overall Improvement by subject and investigatorTimepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90) | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Outcome results
None listed