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临床试验/CTRI/2020/03/024029
CTRI/2020/03/024029尚未招募2 期

Efficacy of Unani formulation in Busoore Labaniya (Acne vulgaris): An open labelled single arm clinical study

National institute of unani medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月19日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
photographs

研究概览

简要总结

Busoore Labaniya also known as “Acne vulgaris†is one of the most common dermatosesof teenagers and young adults. The permissive factor for the expression of the disease is the increase in sebum production by sebaceous glands after puberty. The clinical hallmark of acne vulgaris is the comedone, which may be closed (whitehead) or open (blackhead)

***Busoore Labaniya (***Acne vulgaris) is sufficiently common and often heralds the onset of puberty. The prevalence hits its peak during the middle-to-late teenaged period with more than 85% of adolescents affected. A prevalence of acne in women between ages 26 and 44yrs is to be 14%.It is characterized by seborrhea, open and closed comedones, erythematous papules, pustules and in more severe cases nodules, deep  pustules and pseudocysts.According to the Global Burden disease (GBD) study it affects 85% of young adult aged 12-25 years. Acne consistently represents  the top three most prevalent skin condition in the general population, as found in large  studies with in the UK,   FRANCE and the USA. It leads to significant morbidity associated with residual scarring and psychological disturbances such as poor self – image, depression, and anxiety, which leads to a negative impact on quality of life.

In conventional therapies, Busoore Labaniya is treated either pharmacologically or surgically. Pharmacological therapy includes topical application of retinoids or oral administration of antibiotics and anti-androgens, while surgical intervention includes incision and curettage of cysts.The long term use of these treatment modalities are often associated with certain side effects like erythema, irritation, peeling, burning, drying and bleaching of skin; use of isotretinoin has teratogenic effects and tetracycline causes gastrointestinal discomfort and diarrhea, etc.Therefore, there is a dire need to develop a safe and effective regimen for the management of Busoore Labaniya.

In view of high prevalence, side effect of drugs of conventional medicine, present study has been designed to validate the effect of paste in Busoore Labaniya (Acne Vulgaris). The ingredients of formulations are  Murdarsang, Bora Armani and Roghan gul. Function of Murdarsang is Jali (detergent), Akkal (corrosive), Mujaffif (desiccative), Muhallil (resolvent), Qabiz (astringent), Mukhrij balgham (expectorant). The function of Bora Armani is Jali (detergent), Mujaffif (desiccative), Muhallil (resolvent), Mukhrij belgham (expectorant), Gussal (lavage), Dafa-Taffun(antiseptic), Qabiz (astringent). The function of Roghan gul is Radah (derivative), Qabiz (astringent), Muhallil (resolvent), Mufattih (deobstruent), Musakkin (analgesics).

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

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

入选标准

  • 1- Patients of age group 14-40years, Both genders.
  • 2- Clinically diagnosed patients of Acne vulgaris.
  • 3- Patients/ Guardians who agree to sign the informed consent form and follow the protocol.

排除标准

  • 1- Patients who do not co-operate.
  • 2- Age <14 and >40 years.
  • 3- Patients having local wound and infection on face 4- Pregnant and lactating women.
  • 5- Patient with systemic diseases like Diabetes Mellitus, hypertension.
  • 6- Patients on corticosteroid therapy, anticonvulsant therapy, or taking OCP 7- Patient suffering from other concomitant disease like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc.

结局指标

主要结局

photographs

时间窗: Weekly for 4 weeks

Cardiff acne Disability index

时间窗: Weekly for 4 weeks

Improvement in Global Acne Severity Scale

时间窗: Weekly for 4 weeks

次要结局

  • Improvement in QOL(Erythema)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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