A Prospective,open labelled, single arm,non randomized, single centric,phase II,clinical trial to determine the effectiveness of parangipattai chooranam in the management of azhal keel vaayu (osteoarthritis of knee)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Government Siddha Medical College and Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome will be aimed at reducing the symptoms of Azhal keel vaayu and to determine the effectiveness of parangipattai chooranam
Overview
Brief Summary
This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF PARANGIPATTAI CHOORANAM IN THE MANAGEMENT OF AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The trial drug PARANGIPATTAI CHOORANAM is freshly prepared and will be administered at the dosage of 1 to 3 gms ( Twice a day orally) with milk (pasum paal) as adjuvant for 48 days for 40 osteoarthritis of knee patients ( 20 OP & 20 IP patients). The primary outcome will be determining the effectiveness of PARANGIPATTAI CHOORANAM (INTERNAL) in the management of AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The secondary outcome will be to collect various Siddha literatures and modern journals for literature review on AZHAL KEEL VAAYU, to study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, to perform physicochemical, phytochemical, bio chemical analysis of PARANGIPATTAI CHOORANAM, to evaluate safety profile for acute and sub-acute toxicity of -PARANGIPATTAI CHOORANAM, to evaluate pharmacological activities of PARANGIPATTAI CHOORANAM, to study about the prevalence of AZHAL KEEL VAAYU in relation with diet and lifestyle, to evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in AZHAL KEEL VAAYU during trial period, to evaluate DHEGI of AZHAL KEEL VAAYU patients, to evaluate modern parametric changes in AZHAL KEEL VAAYU, to assess the quality of life (QOL) of AZHAL KEEL VAAYU patients and to document Bio statistical analysis
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients presenting with Joint pain 2.Morning stiffness for less than 30 minutes 3.Crepitus on active movements 4.Joint line tenderness 5.Difficulty in Range of motion 6.Patient presenting with or without swelling.
Exclusion Criteria
- •Patients with history of Trauma and post- trauma 2.Ligament tear 3.Patient undergone knee replacement surgery 4.Metabolic joint disease 5.Infectious joint disease(tuberculosis,polyarthritis) 6.Inflammatory arthritis(Rheumatoid arthritis) 7.Septic arthritis 8.Osteomyelitis 9.Chronic liver and renal diseases.
- •10.Malignancy.
Outcomes
Primary Outcomes
The outcome will be aimed at reducing the symptoms of Azhal keel vaayu and to determine the effectiveness of parangipattai chooranam
Time Frame: 48 days
Secondary Outcomes
- 1.To collect various aspects of Azhal keel vaayu in Siddha literatures.(2.To evaluate physico chemical,phyto chemical and bio chemical characters of parangipattai chooranam.)
Investigators
S KAVIYA
Government Siddha Medical College and Hospital palayamkottai