跳至主要内容
临床试验/CTRI/2022/06/043510
CTRI/2022/06/043510尚未招募不适用

An Open-Label, Single-Arm Clinical Study to evaluate the Safety and Tolerability of Purim Tablet in Healthy Adultsâ€

Himalaya Wellness Company1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Occurrence of any adverse or serious adverse

研究概览

简要总结

Dermatitis is a general term that describes a skin irritation. Dermatitis is a common condition that has many causes and occurs in many forms. It usually involves itchy, dry skin or a rash on swollen, reddened skin. Or it may cause the skin to blister, ooze, crust or flake off. Dermatitis can be acute or chronic or both. Acute eczema (or dermatitis) refers to a rapidly evolving red rash which may be blistered and swollen. Chronic eczema (or dermatitis) refers to a longstanding irritable area. It is often darker than the surrounding skin, thickened (lichenified) and much scratched.

Acne vulgaris is a chronic inflammatory dermatosis which is distinguished by open and/or closed comedones (blackheads and whiteheads) and inflammatory lesions including papules, pustules, or nodules. The bacterium responsible for clinical course of acne is Propionibacterium acnes (P.acnes) which is a gram-positive anaerobe that normally inhabits the skin and is implicated in the inflammatory phase of acne.

Acne lesions occur in the pilosebaceous unit, which consists of the hair follicle, the hair shaft, and the sebaceous gland. The initial step is the formation of microcomedo, both in inflammatory and non-inflammatory acne. It arises from the interplay of 4 pathogenic factors: sebum production, follicular hyper keratinization, microbial colonization of the pilosebaceous unit by Propionibacterium acnes, and the release of inflammatory mediators into the follicle and surrounding dermis.

Purim has antimicrobial, anti-inflammatory, anti-allergic, wound-healing, antioxidant and immunomodulatory properties which synergistically act in managing symptoms of skin conditions. The anti-microbial and immunomodulatory property of Purim helps check infection in acne and prevents infection in susceptible inflammatory skin conditions. The anti-allergic property helps relieve itching associated with dermatitis and relieve symptoms of allergic skin conditions. The anti-inflammatory and property acts on various inflammatory cascades involved in dermatitis and acne and promotes healing. The wound healing and antioxidant property protects tissue from damage and promotes healing.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Healthy adult subjects of either sex aged between ≥18 to ≤50 years.
  • Subjects willing to sign informed consent and follow the study procedure.
  • Has not participated in a similar investigation in the past four weeks.
  • Subjects willing to refrain taking any other nutritional supplement during the study period.

排除标准

  • Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder.
  • Subjects with any abnormal lab values detected at screening shall be excluded.
  • A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational products (IP).
  • Pre-existing systemic disease necessitating long-term medications.
  • Genetic and endocrinal disorders.
  • Subjects who refused to sign informed consent.
  • Pregnant and lactating women.

结局指标

主要结局

Occurrence of any adverse or serious adverse

时间窗: 7 days.

events during the study period.

时间窗: 7 days.

次要结局

  • Overall compliance to the study medication(7 days)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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