A clinical study on the comparative assessment in the treatment of Gouty Arthritis (Niqris) with extract and crude form of the Unani polyherbal formulation, a randomized controlled trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Serum uric acid and pain (Wong Baker’s Faces rating scale 0-10) will be assesed
Study Overview
Brief Summary
This study is a randomized, parallel group trial to evaluate the efficacy and safety of the extract form of the Unani polyherbal formulation inreducing hyperuricemia and its manifestations by using modern parameters and to compare its efficacy with crude form of same UnaniPolyherbal Formulation. The individuals affected with gout are at increased risk of Hypertension, Diabetes Mellitus, MetabolicSyndrome, Kidney and Cardiovascular disorders and thus are at increased risk of death. Due to thesecomplications, Gout has become a distressing problem, despite advancement of modern science.Several agents are already being used such as NSAIDs (Indomethacin, Ibuprofen etc), Colchicine,Xanthine oxidase inhibitors (Allopurenol, Febuxostat etc) , but long term use of these drugs lead todevelopment of various side effects like, gastrointestinal upset, GI bleeding, skin rashes, anaemia,vomiting, diarrhoea, kidney damage, Stevens-Jonsons syndrome, peripheral neuritis etc. Thereforesearch for safe and effective drug is the need of the time especially from herbal source. Unani scholarshave described Principles of treatment for management of gout and many safe and effective single aswell as compound drugs in classical Unani literature for the same purpose. In the recent past, twostudies have been conducted in the Moalijat department of A & U Tibbia Hospital and the results ofthe studies were found very encouraging. i.e: 1. A Placebo control study, conducted in 2008 under supervision of Prof. Rais-ur-Rahman ongouty arthritis resulting in more than 80% of efficacy. 2. A standard control study, done in 2012 in which allopurinol was taken as standard control withmore than 80% efficacy in gouty arthritis.In both the studies, the same unani polyherbal formulation was given in crude (powder) form. In thecurrent study, we are planning to use extract form of the same Unani Polyherbalformulation to compare the effectiveness between powder and extract form.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient with clinical features of gouty arthritis, Serum uric acid more than 7 mg/dL, Patient willing to discontinue the drugs taking for the treatment of gouty arthritis, Patient willing to participate in the study and sign the informed consent form.
Exclusion Criteria
- •Patient having Gouty arthritis with its complications such as Tophi and renal stones etc, Pregnant and lactating women, Patient receiving Uric acid elevating drugs eg, Pyrazinamide, Thiazide group of diuretics / Aspirin / NSAIDs and Anti-gouty drugs, Renal insufficiency, Hepatic insufficiency, Cardiovascular disorders, Haemopoietic disorders, Patient suffering from malignancy, taking chemo and radiotherapy.
Outcomes
Primary Outcomes
Serum uric acid and pain (Wong Baker’s Faces rating scale 0-10) will be assesed
Time Frame: 6 weeks
Secondary Outcomes
- Tenderness, joints sweelling, joints movement,CRP, ESR will be assesed(6 weeks)