A Clinical Study to Evaluate the Efficacy and Safety of a Unani Formulation in the management of Niqris(Gouty Arthritis) : A Randomized Controlled Clinical Trial.

Niqris (Gout) is the most common inflammatory arthritis worldwide. The prevalence of

Niqris gout ranged 1–4% worldwide and incidence ranged 0.1–0.3%. Gout incidence and

prevalence increases by each decade of life.

Gout is more common in men vs. women by 3:1 to 10: 1. . In men the reported prevalence

ranges from 7% in those aged over 75. It is rare in premenopausal women but increases to

2.5 – 3.0% in those aged over 75.

The cases of Niqris (gout) increasing day by day due to increased prevalence of obesity,

poor life style and metabolic syndrome of which hyperuricemia is an integral component.

Serum uric acid (SUA) is the end product of purine metabolism. In most cases (5 – 25%)

excess of SUA or hyperuricemia occurs due to impaired renal urate excretion. While other

develop hyperuricemia due to over production of uric acid.

In Modern Medicine, drugs like NSAIDs, Colchicine, Gluco-corticoids, Probenecids, XO

inhibitors (Allopurinol and Febuxostat) are being used for the treatment of the gout. XO

inhibitors impede the synthesis of uric acid and are used for lowering the blood uric acid

level. XO inhibitor like Febuxostat and Allopurinol are the drug of choice for gout.

Oral colchicine, NSAIDs along with intra-articular injection of soluble steroids are used to

suppress the attack of acute gout. Both colchicine and NSAIDS may be poorly tolerated

and dangerous in the elderly and in the presence of renal insufficiency and gastrointestinal

disorder. . XO have side effects of causing stomach ulcers, GIT bleeding, kidney and liver

damage etc.

Herbal remedies have been popular since antiquity of being relatively less expensive and

believed to be free of adverse effects. The unani drugs have proven its own importance

regarding its affectivity cost and minimal side effects.

In unani classical literature, for the treatment of various types of arthritis, a number of

treatment modalities like use of single and compound drugs such as Sooranjan sheerin

(Colchium luteum), Zaravand (A.longa & rotunda), Sibr (Aloe indicum), Haleela zard

(Terminalia chebula), Bozidan (Pyrethrum indicum), Zanjabeel khushk (Zingiber

officinalis) and Safuf Chobchini, Habbe Sooranjan etc. as well as Regimental Therapies

like Fasd, Hijama and Irsale alaq have been mentioned, which have potential role in

treating the disease on the basis of their Munzij (concoctive) Mushil (purgative), Mudir

(Diuretic), and Muarrik (diaphoretic) property by the evacuation of morbid matter.

So keeping all these therapeutic aspects in mind, some potent unani drug like Bozidaan

(Pyrethrum indicum), Khare khasak khurd (Tribulus terestris), Chobchini (Smilax china),

Aftimoon (Cuscuta reflexa), Muqil azrak (Commiphora mukul) which poses Mohallil

awram (Anti-inflammatory),  Mudir-e bowl (diuretic), Mulattif (demulcent), Mushil e

safra, Mushil e balgham (Purgative) and Munzij-e balgham wo sauda (concoctive) property

have been chosen for the study. Though these drugs are being used for the treatment of

Niqris (gout) since long, but their efficacy and safety are not scientifically proved yet.Therefore viewing the above fact it has been planned to conduct a clinical trial to evaluate

the efficacy and safety of these drugs in gout on scientific parameters with the title: “A

Clinical Study to Evaluate the Efficacy and Safety of Unani formulation in the

Management of Niqris (Gouty Arthritis): A Randomized Controlled Clinical Trial.