Randomized, parallel arm, controlled clinical trial to evaluate the efficacy and safety of HFPM-01 in improving pain, stiffness and inflammation in patients suffering from knee osteoarthritis - NI

Siddhayu Ayurvedic Research Fdn Pvt Ltd0 sites90 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 27, 2020

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Siddhayu Ayurvedic Research Fdn Pvt Ltd

•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