Background: The conventional drugs used for gout are full of adverse effects (hepatotoxicity, nephrotoxicity, haematological toxicity).The need of the time is to develop evidenced based safe and cost effective hypouricemic agent which can easily counteract treatment-failure gout and minimize the suffering of the patients and improve their quality of life. A unani formulation having Colchicum luteum baker, Aloe Indica, Terminalia Chebula, Carthamus tinctorius, Zingiber Officinale, as the ingredients was selected for the clinical study on Gout and was intended to overcome the above demerits and bring to light a Unani formulation which was being used for thousands of years.

Objective: The aim of this single blind placebo control study was to evaluate the efficacy and tolerability of Unani formulation in the diagnosed patients of Gout based on scientific parameters.

Methods: Patients with acute gouty arthritis were randomised. Test group received the drug in the dose two tablets thrice in a day (5g) while the control group was given inert substance in equal dose. The subjective parameter: pain and the objective parameters: Tenderness, Movement, Health assessment Questionnaire-Disability Index, Serum uric acid, Erythrocyte Sedimentation Rate were evaluated on days 0,7,28 and 40.

Results: In test group the pain improved from 5.95 ± 1.54 at the onset of drug therapy to 4.50 ± 1.91 on the 7th day, 3.30 ± 1.72 on 28th day and 1.85 ± 1.98 on the termination of treatment. The improvement in tenderness proceeded from 2.0 ± 1.12 (0 day) to 1.75 ± 0.97 (7th day) to 1.05 ± 0.94 (28th day) and 0.60 ± 0.59 (40th day).Improvement seen in restriction of movement was from 1.70 ± 0.86 (0 day) to 1.35 ± 0.59(7th day) to 0.85 ± 0.67 (28th day) to 0.55 ± 0.51 (40th day).There was marked improvement in Health assessment Questionnaire-Disability Index since within the group difference was extremely significant (p<0.001) with mean value of 8 ± 4.75 at the onset of treatment and 2.85 ± 2.58 at the termination. There was drastic change in the serum levels of uric acid with a rapid decrease from 6.21 ± 1.62 on 7th day to 6.27 ± 1.52 on day 28th to 5.55 ± 1.57 on day 40th which in all the three follow ups is extremely significant(p<0.001). The E.S.R observed in test group was 25 ± 11.53 at 7th day,25.30 ± 10.27 at 28thday,22.30 ± 12.02 on 40th day, not significant on all the three occasions.

Conclusion: The test drug has significant analgesic and anti-inflammatory activity. It is effective in lowering serum urate level with minimal side effects. It also minimised the suffering of the patients. However, a large scale, prospective, double blind, randomized controlled study is warranted to support the efficacy of test formulation in the treatment of gouty arthritis.