A single blind observational study to evaluate the safety and efficacy of polyherbal formulation in the management of Niqris (Gout).

Niqris (Gout) is one of the most common types of inflammatory jointdiseases creating difficulty and problems in day to day life. Itis characterized by recurrent attacks of acute pain and swelling primarily affecting one joint usually the metatarso-phalangeal joint of big toe and small joints of feet and hands, commonly affects both feet.The prevalence of Gout varies between population but is approximately 1-2% and out of the affected population males are more common while females of the postmenopausal group are at high risk. According to Hippocrates, it occurs rarely in children and premenopausal women and does not occur in transgenders.Six centuries later to Buqrat,  Jalinoos was the first to describe tophi. An excessive intake of food containing high purine contents (Baadi Ghiza) is the primary or essential cause of Gouty Arthritis (Niqris), which results in deposition of Maddah-e-Niqris (urates or tophi), in the articular and periarticular tissues.In modern medicine NSAID’s, Uricosuric drugs, colchicine, glucocorticoids etc. are used for subsiding acute attacks or lowering serum uric acid which is associated with potent adverse effects like vomiting, GI bleeding, hepato-renal toxicity, hypersensitivity etc. The side effects of all above-mentioned drugs call for the development of novel drugs or methods of treatment used with similar and better efficacy and lesser toxicity than presently available drugs.Now a days Unani system of Medicine is getting authentication for the treatment of such type of disease by its unique concept which is equilibrium of humors, for this purpose different methods of treatment are applied like Ilaj bil Giza (Dietotherapy), Ilaj bil Dawa (Pharmacotherapy) , Ilaj bil Tadbeer (Rehimenal Therapy), and Ilaj bil Yad (Surgery). The Unani medicines being having less side effects are more beneficial, thus the present study has been designed to study the efficacy and safety of the poly herbal formulation, constituting the drugs namely Suranjan (ColchicumLuteum), Khulanjan (Alpinia Galanga) and Bozidan (Pyrethrum Indicum)

Diagnostic Criteria: Patients with classical sign and symptom of Niqris (Gout) with uric acid level more than 7mg/dl.

Study design: Single blind, observational study.Sample size: 30 patients

Intervention.

Test group: Powder of Suranjan, Khulanjan and Bozidan.

Method of Prepration: The drugs will be grinded into fine powder and all will be mixed properly.

Dosage: 5 gm of each drug ie a total of 15grams of drug will be given in three divided doses every day.

**Route of Administration:**Oral

Duration   of Protocol: 60 days with follow up as ( 15th, 30th,45th,60th)

Duration of Study: 2 years

Procedure of study:

Enrolled cases of Gout will be recruited after obtaining a written informed consent.

The pre and post treatment subjective and objective findings (effects) will be compared and its significance will be evaluated through a suitable statistical test.