Evaluation of the efficacy and safety of PR/HC/1718/001 in knee osteoarthritis.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2019/05/019179
- Lead Sponsor
- Aayush Healthcare
- 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, 40 to 70 years of age.
2. Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees
3 Presence of typical osteophytes on skiagram knee is mandatory
4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment.
5. Patient with or without receiving regular anti â?? inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change.
6. Willing to come for regular follow â?? up visits.
7. Written Informed Consent from the patient.
1.Patients with congenital arthropathy, rheumatoid arthritis, active
gout, other type of arthritis with/without inflammation e.g. septic ,
fibromyalgia or collagen vascular disease
2.Patients with known history of coagulopathies
3.Osteoarthritis of any other joint except knee
4.Patients with history of major trauma or surgery in the knee joint
5.Patients with uncontrolled diabetes and hypertension
6. Body mass index (BMI) >40 kg/m2.
7.Patients with any severe cardiac, renal and hepatic disease
8.Pregnant and lactating women
9.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
- Secondary Outcome Measures
Name Time Method