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临床试验/CTRI/2022/10/046562
CTRI/2022/10/046562尚未招募不适用

Scientific evaluation for the effect of a unani Pharmacopoeial compound "NUQU-E-UNNAB" in Shara (Urticaria)

Department of Ilmul Advia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
DECLINE IN WHEALS EPISODES AND ITCHING INTENSITY

研究概览

简要总结

Scientific evaluation for the effect of a unani pharmacopeial preparation “Nuqu-e-Unnab†in shara (urticaria)

1.Urticaria is a vascular reaction of the skin characterized by the appearance of wheals, generally surrounded by a red Hals or flare and associated with severe itching, stinging or pricking sensation.

The actual cause of Shara (Urticaria) is believed to be the Fasad-e-Dam (blood impairment) caused by the vapours of Dam-e-Merari (bilious blood) or Balgham-e-Boraqi (acidic phlegm) coming towards the skin or periphery of the body.

NEED OF THE STUDY

  1. CSU is a highly prevalent disease, It has a great impact on general population representing a burden for national health system due to its variability and yet unknown pathogenesis.

2. CSU significantly impairs the quality of life. The lack of clinical and laboratory biomarkers able to define the severity and prognosis usually leads to frustration of patients as well as of physicians.

3. 3.  Moreover, CSU has a variable rate of response to the approved newest therapies. The therapeutic approach of chronic urticaria aims at symptom relief. Licensed doses (1 tablet daily) of modern second-generation antihistamines are the first line treatment. Levocetirizine is second generation histamine antagonist and it has high affinity and selectivity for H1 receptor. The response rates to current third line treatment like cyclosporine and Omalizumab are each close to 75% but omalizumab is expensive and not reimbursed worldwide while Cyclosporin A has a high incidence of adverse effects. For leukotriene receptor antagonists, the level of evidence for efficacy is low.

4. In a retrospective analysis on the clinical and demographic information of patients with CSU, Sánchez Borges et al. reported that Anti Histaminic resistant-CSU was more frequent among Hispanic female patients (aged 14 to 60 years) and usually associated with other clinical indicators of severity such as atopic asthma, rhinosinusitis, hypertension, and thyroid disease.

WHO reports indicate that around 80%of the global population still relies on botanical drugs and several herbal medicines have been advanced to clinical use in modern medicine (Mahmood Z A et.al 2010).

Unani System of Medicine possesses many drugs that are highly effective for the treatment of skin diseases caused by imbalance in akhlat. Going through the literatures it is found that many single and compound formulations have been described for these purposes in various pharmacopoeias. One such nuskha is taken from “QARABADEEN QADRI†by Hm. Akbar Arzani, CHAPTER 20, PAGE NO. 475 “matba munshi nawil Kishore Lucknow pressâ€. In the recent study Nuqu-e-unnab has been proposed to carry out its efficacy in shara through preclinical as well as clinical subjects.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
14.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed patients of CU according to the 2018 EAACI/GA2LEN/EDF/WAO guideline
  • Patients willing to sign consent form for the study.

排除标准

  • Patients less than 14 and more than 60 years of age.
  • concomitant skin disease.
  • Patients suffering from any other systemic diseases, pregnant and lactating women.
  • unwillingness or inability to fulfil the protocol.

结局指标

主要结局

DECLINE IN WHEALS EPISODES AND ITCHING INTENSITY

时间窗: EVERY FORTNIGHT UPTO 6 WEEKS

次要结局

  • IMPROVEMENT IN OBJECTIVE PARAMETERS LIKE QoL QUESTIONNAIRE, UAS7 AND BLOOD REPORTS(BEFORE AND AFTER STUDY)

研究者

发起方
Department of Ilmul Advia
申办方类型
Other [Department of Ilmul Advia, Ajmal khan Tibbiya College, A.M.U, Aligarh]

研究点 (1)

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