Clinical trial of knee osteoarthritis
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2020/07/026655
- Lead Sponsor
- Siddhayu Ayurvedic Research Fdn Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of patient on pain VAS scale, WOMAC scale <br/ ><br>Improvement in SF-36 Health Survey score <br/ ><br>Symptomatic relief including pain, inflammation, stiffness, swelling, joint flexibility, weight bearing capacity <br/ ><br>Levels of inflammatory mediators CRP and ESR in blood <br/ ><br>Proportion of subjects requiring analgesics as rescue medication <br/ ><br>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 Outcome Measures
Name Time Method Tolerability of study drug by assessing adverse events, serious adverse events during the study period. <br/ ><br>Pain status and improvement in symptoms for other than knee pain if any (Shoulder, back ache and muscle spasms) <br/ ><br>Vital signs like pulse, BP during the study period <br/ ><br>Safety parameters including CBC, LFT, KFT, Urine routine and UPT. <br/ ><br>Overall Improvement by subject and investigatorTimepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)