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临床试验/CTRI/2020/10/028663
CTRI/2020/10/028663已完成2 期

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.

Ayurvedic and Unani Tibbia College Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月11日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Serum uric acid and pain (Wong Baker’s Faces rating scale 0-10) will be assesed

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Serum uric acid and pain (Wong Baker’s Faces rating scale 0-10) will be assesed

时间窗: 6 weeks

次要结局

  • Tenderness, joints sweelling, joints movement,CRP, ESR will be assesed(6 weeks)

研究者

发起方
Ayurvedic and Unani Tibbia College Hospital
申办方类型
Government medical college

研究点 (1)

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