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临床试验/CTRI/2023/09/057624
CTRI/2023/09/057624尚未招募不适用

Clinical Evaluation of the Effect of Irsal-e-Alaq (Leech Therapy) in the Management of Niqris (Gout)

Aligarh Muslim University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
VAS

研究概览

简要总结

Niqris originated from the Greek word *“Anquroosâ€*which means big toe (the first metatarsophalangeal joint). This is the classical site for the beginning of this disease, hence the disease got this name. Renowned Unani scholars Ibn-e-Sina, Majoosi, Jurjani, Antaki described that Madda-e-Niqrisiya (Morbid matter) accumulated in intra-articular space especially in big toe cause pain and inflammation.

In modern system of medicine this disease is called ‘GOUT’. Gout is common inflammatory condition of joint. It is caused by deposition of monosodium urate crystals within the joints after chronic hyperuricemia. Prevalence of hyperuricemia varies according to the age, sex, race, geographical conditions and association with other diseases. It becomes common with increasing age: it is <0.5% in men under the age of 35 years and >7% in those aged over 75 years. It is rare in premenopausal women and increases to 2.5%-3.5% in those aged 75 years of age.

Irsal-e-Alaqis an ancient regimen of Ilaj-bit-Tadbeerused for diversion and evacuation of Akhlat-e-Fasida (morbid matter) by application of Leech on the affected parts of the body surface. Blood letting in the form of leech therapy has been utilised for preventive as well as curative measures for thousands of years by ancient Unani scholars.

 Habb-e-Suranjan is the most common Unani medicine that is used in joints pain. It has anti inflammatory and analgesic actions.

In Conventional system of medicine there is no permanent cure for Gout, only symptomatic treatment is available with analgesics and NSAIDs like Indomethacin and Urate lowering drugs like Allopurinol, Probenecid, Febuxostat etc.These drugs have many side effects.

In Unani System of Medicine many single/ compound drugs like Zanjabeel, Muqil, Darchini, Majoon Chobchini, Habb-e-Suranjan, Habb-e-Asgandetc with regimenal procedures like Hijamah-bish-Shurt (wet cupping), Irsal-e-Alaq etc. are prescribed to treat gout with minimal/no side effects. Leech saliva has several bioactive substances that are anti-inflammatory, anticoagulant, vasodilator, anaesthetic etc. Leech therapy has no adverse effect in comparison to conventional medicine. The antiiflammatory and analgesic properties of leech saliva will be helpful in treating the painful condition of joints. Therefore, it is proposed to evaluate the efficacy of leech therapy in the management of Gout.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • Diagnosed cases of Gout Patients willing to give informed written consent.

排除标准

  • Patients below the age of 25 and above the age of 65 years Patients with uncontrolled Diabetes Mellitus & Hypertension Pregnant and lactating patients Patients with systemic disorders like Chronic Renal Failure & Coronary Artery Disease Diagnosed cases of Osteoarthritis and Rheumatoid Arthritis Patients having malignancy, psychological disorder Patients taking Pyrazinamide Immunocompromised patients Patients of bleeding disorders, severe anaemia, hypotension.
  • Patients having allergy to leech Patients who refuse to sign the consent.

结局指标

主要结局

VAS

时间窗: Assessment on | Baseline | 14th day | 28th day

Serum uric acid level

时间窗: Assessment on | Baseline | 14th day | 28th day

次要结局

  • Gout Impact Scale(Tenderness)

研究者

申办方类型
Government medical college

研究点 (1)

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