An open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee joint)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in severity of joint pain,stiffness and improvement in joint movements,physical functioning and quality of life
Study Overview
Brief Summary
This study was an open labelled non randomized phase II clinical trial to evaluate the effectiveness of kalvaazhai kattu (Bandage in siddha external therapy)in the management of Azhal keel vayu (osteoarthritis of knee joint).The trail drug procedure will be given for one time in a day at an interval at an 3-7 days upto 3-7 Kattu for 21 days in 40 patients.The trial drug will be carried out in Government siddha medical College and hospital, palayamkottai,Tirunelveli 627002.The outcome will be Reduced severity of joint pain,Stiffness and improvement of joint movements and quality of life.In case of any adverse events was noticed and it will be referred to pharmacovigilence department.Further management of patients will be given OPD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having symptoms of 1.Pain in single or both knee joints 2.Swelling 3.Tenderness 4.Stiffness 5.Crepitation 6.Restricted movements Patients who are willing to undergo Kattu (Bandage in siddha external therapy) Patients who are willing to give specimen of blood for investigation whenever required.
- •Patients who are willing to attend OPD or admission in IPD for 21 days.
- •Patients who are willing to take external therapy along.
Exclusion Criteria
- •History of tuberculosis History of hepatitis B,AIDS,Syphilis.
- •History of Haemophilia & anticoagulant treatment.
- •Rheumatoid and other types of arthritis.
- •Trauma, fracture,ligament injury.
- •History of psychiatric disorder.
- •Surgery of the affected knee joint during the previous 3 month or joint replacement.
Outcomes
Primary Outcomes
Reduction in severity of joint pain,stiffness and improvement in joint movements,physical functioning and quality of life
Time Frame: 21 days
Secondary Outcomes
No secondary outcomes reported
Investigators
DrRAnand
Government siddha medical College and hospital, Palayamkottai.