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临床试验/CTRI/2024/09/073345
CTRI/2024/09/073345招募中2/3 期

Efficacy of Tila Qatran Madani with Shibb Yamani versus Permethrin in Jarab (Scabies) - A Randomized Control Clinical Trial

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年9月9日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
38
试验地点
1
主要终点
Negative Dermoscopy

研究概览

简要总结

Scabies is an intensely itchy parasitic disease of the skin caused by microscopic scabies mites that are transmitted from person to person via close contact.Human scabies is caused by the mite Sarcoptes scabei var. hominis, which is an obligate ectoparasite that lives in the human epidermis.The WHO estimates that there are more than 200 million scabies cases worldwide, however this number certainly drastically underestimates the true scope of the condition. Scabies is more prevalent in vulnerable groups such as young children and the elderly.The Global Burden of Diseases study estimates that scabies affects 455 million persons leading to approximately 3.8 million disability-adjusted life-years (DALYs); making scabies one of the most common neglected tropical diseases. Scabies has serious physical repercussions, but it also has severe psychosocial implications, including itchiness, insomnia, decreased productivity, low quality of life, and in one research, a sense of shame in 77% of those who had it.The first-line treatments of scabies include oral ivermectin and topical permethrin. Malathion,Topical sulfur, Benzyl benzoate, crotamiton, topical ivermectin and lindane are examples of other treatment agents.Adverse effects of antiscabetics occur infrequently and are limited to local cutaneous reactions including erythema, burning, pruritus and post scabies eczema.The use of antiscabetics cause irritant dermatitis on the face and scrotum, repeated usage may lead to allergic dermatitis. neurotoxicity, cramps, CNS toxicity, dizziness and convulsions.  It is forbidden in pregnant and lactating women, infants, and young children less than 2 years of age.Even though there has been a lot of exploration and extensive research on scabies treatment around the world to date, but still the excellent treatment is obscure.In Unani system of medicine various single drugs and compound formulatios such as Ḍimād e jaraband Gandhak possessing Muḥallil (resolvent), JālÄ«(detergent), Daf‘-i-Ta‘affun (disinfectant), and Mudāmmil -e- QurÅ«hÌ£ (cicatrizant) properties have been scientifically proven to be effective in treatment of scabies. Qatran e ma’dani and Shibb e yamani, ancient, effective and affordable drugs possessing above mentioned properties yet not been scientifically proven are selected for clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
8.00 Year(s) 至 39.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex Diagnosed case by IACS criteria Age more than 8 years to 39 years Pruritus without excoriation since 6 months.

排除标准

  • Pregnant and lactating women Use of topical and systemic acaricide drugs from past 1 month.

结局指标

主要结局

Negative Dermoscopy

时间窗: 0,7,14 day

Decrease in Pruritus

时间窗: 0,7,14 day

Negative KOH scraping

时间窗: 0,7,14 day

次要结局

  • Decrease in no of lesions(Burrow Ink Test)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Zainab Aman

National Institute of Unani Medicine

研究点 (1)

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