Evaluation of efficacy and safety of Polyherbal unani paste for local Application in the Management of Knee Osteoarthritis
- Conditions
- Health Condition 1: M17- Osteoarthritis of knee
- Registration Number
- CTRI/2024/03/063596
- Lead Sponsor
- Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Patient fulfilling the inclusion criteria and agree to follow the protocol
2) Diagnosed cases according to American College of Rheumatology Criteria of Osteoarthritis and classified as grade II or III for OA of the knee according to Kellgren Lawrence Grading system
3) Patients with symptoms consistent with Osteoarthritis of the knee for at least six months prior to screening These symptoms include joint pain and also include crepitus swelling and/or effusion of the knee
4) At screening patients on any analgesic/anti-inflammatory medication shall be screened on visual analog scale (VAS) of pain after walking on a 50 ft flat surface of greater than 30 mm but lesser than 90 mm using a 100 mm scale If patients taking no analgesic/anti-inflammatory medication in the previous 3 days from screening then they should have VAS pain score after walking on a 50 ft flat surface of greater 40 mm but lesser 90 mm If bilateral knee pain is present the more painful knee will be selected
5) At screening and baseline if there will be bilateral OA of the knee involvement patients must have a VAS pain score after walking on a 50 ft flat surface of lesser than 30 mm in the less painful contralateral knee at the baseline assessment
6) Patient who can perform the 50-feet walk test without the support of crutches or other assistive devices
7) Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition including their knee pain
1) Patients participating in an experimental device study or any clinical trial within the previous 30 days prior to screening
2) Any knee surgery in the previous three months
3) Patient with Kellgren-Lawrence Grade I and grade IV OA of the knee
4) Other types of arthritis
5) Patients with any inter current disease (s) or condition (s) that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the completion of the 4 week follow up (neurological problems, severe congenital defects, peptic ulcer, severe liver disease, severe coronary disease, renal disease, Active Psychiatric disorder, or other clinically significant conditions)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method