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临床试验/CTRI/2024/02/063169
CTRI/2024/02/063169尚未招募2 期

Evaluation of efficacy and safety of a topical Unani formulation in ButhuÖ¿r Labaniyya (Acne Vulgaris).

Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年3月1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
44
试验地点
1
主要终点
Change in Global Acne Grading System Scale (GAGS) of Acne

研究概览

简要总结

Buthuֿr Labaniyya (Acne vulgaris) is a chronic inflammatory disease of the pilosebaceous units and is characterized by seborrhea, the formation of comedones, erythematous papules and pustules, less frequently by nodules, and, in some cases, is accompanied by scarring. The main cause of acne is excessive sebum production, and microbial colonization by Propionibacterium acne. According to classical Unani literature, the main cause of Buthuֿr Labaniyya is the hyperactivity of Ghudud-e-Dohniya (sebaceous glands), which results in increased production of oily material, which gets clogged into the openings of these glands, and then inflamed, which remains unresolved in the skin. It is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.In India, acne is prevalent in 72.3% of adolescents and 27% of the adult age group. In modern system of medicine, which includes topical and systemic antibiotics, such as benzoyl peroxide, doxycycline, clindamycin, etc. and retinoids are also infrequently used. These drugs have several limitations, long-term use of these medications causes serious adverse effects such as erythema, peeling, burning, and drying of the skin. Additionally, Propionibacterium acne drug resistance may restrict the use of topical antibiotics and producing only symptomatic relief. In the classical literature of Unani, a number of formulations and single drugs are mentioned for the management of acne and also very effective in scar prevention. These polyherbal medications mainly have Jali (Detergent), Muhalil (Resolvent), and Mujaffif (Desiccative) properties and have been used by ancient Unani physicians for centuries to treat Buthuֿr Labaniyya.This polyherbal topical Unani formulation is selected from Al-Qarabadin and Ḥāziq which includes, Irsa (Iris ensata), Post-e-Siras (Albizia lebbeck) and Barg-e-Neem (Azadirachta indica) will be evaluated in the management of Buthuֿr Labaniyya.

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
13.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex.
  • Patients of 13 to 40 years of age.
  • Mild to moderate acne as defined by the Global Acne Grading System (GAGS) scale.
  • Patients willing to sign the informed consent form.

排除标准

  • Patients suffering from any skin disease like vitiligo, psoriasis, eczema, etc.
  • Immunocompromised condition.
  • Any active psychiatric illness.
  • Pregnant and lactating women.
  • Patients with any systemic illness such as the known case of DM, HTN, etc.
  • which might interfere with the follow-up and assessment during our study.

结局指标

主要结局

Change in Global Acne Grading System Scale (GAGS) of Acne

时间窗: Baseline,2nd week,4th week,6th week

vulgaris, from baseline to end of treatment.

时间窗: Baseline,2nd week,4th week,6th week

次要结局

  • DLQI (Dermatology Life Quality Index)(Baseline and 6th week)

研究者

发起方
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Atoofa

Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital

研究点 (1)

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