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临床试验/CTRI/2020/06/025718
CTRI/2020/06/025718尚未招募2 期

“Clinical Study of Buthur Labaniyya (Acne Vulgaris) With Therapeutic Evaluation of Topical Unani Drug, Shoniz (Nigella sativa) and Sirka (vinegar) in its Management.â€

Central Council for Research in Unani MedicineNew Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Relief in signs and symptoms of acne vulgaris (Buthur labanniya)

研究概览

简要总结

Buthur labanniya (Acne vulgaris) is a chronic inflammatory disease of pilosebaceous unit presenting with seborrhoea, open and closed comedones, papules, pustules and nodulocystic lesions in severe cases. It affects primarily the face, neck, upper trunk and upper arms. It has been estimated that 70% of general population have some clinically evident acne at some stage during adolescence. As per classical Unani literature, Buthur labanniya are tiny white eruptions on nose and cheeks which resemble with condensed milk droplets. These are caused by suppurative matter which comes to the surface of skin due to bukharat (vapours) of the body.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically stable patients of Buthur labanniya 2.Patients having comedones,papules,pustules,itching and erythema 3.Patients willing to give consent 4.Patients irrespective of gender 5.Patients in the age group of 10 to 40 years.

排除标准

  • 1.Patients below the age of 10 and above the age of 40 2.Pregnant females 3.Lactating mothers 4.Mentally retarded persons 5.Patients with severe acne 6.Patients on corticosteroid therapy,anticonvulsant therapy or taking oral contraceptives 7.Patients suffering from other concomitant diseases like acne rosacea,acne fulminans,acne necrotica,psoriasis or eczema etc 8.Patients diagnosed of PCOS 9.Patients with diabetes mellitus,chronic kidney disease and chronic liver disease 10.Patients with thyroid disease 11.History of allergy to Benzoyl Peroxide 13.Patients who fail to give consent 14.Patients who have used any anti acne treatment in last 30 days.

结局指标

主要结局

Relief in signs and symptoms of acne vulgaris (Buthur labanniya)

时间窗: 2 to 8 weeks

次要结局

  • Haematological and biochemical assessment for safety(2 to 8 weeks)

研究者

发起方
Central Council for Research in Unani MedicineNew Delhi
申办方类型
Research institution

研究点 (1)

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