跳至主要内容
临床试验/CTRI/2023/07/055205
CTRI/2023/07/055205尚未招募2 期

Evaluation of In vitro Anti-psoriatic Activity of a Novel Polyherbal UNIMFormulation by Multiparametric Analysis

Central council for Research in Unani Medicine1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年7月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
The present study will provide an understanding about the cellular level via multiple arms (ant proliferative, pro-apoptotic, anti-inflammatory, anti-antigenic) of UNIM formulation (UNIM401).

研究概览

简要总结

Psoriasis has been recognized as a chronic inflammatory disease of the skin characterized by an accelerated rate of keratinocyte proliferation, alteration in dermal angiogenesis and increased production of proinflammatory cytokines.In conventional system of medicine topical and oral steroids with or without phototherapy are commonly prescribed for the management of psoriasis. But long term use of these medicines may invite several unwanted adverse side effects like hypertension, hypercholesterolemia, etc. So there is a dire need to develop new formulation which can provide long term relief without major side effects. Unani system of medicine is concerned Psoriasis is described under the heading of Taqashshure Jild caused by deposition of Khilte ghaleez (Abnormal Sauda) in skin, and treated by various modes of treatments. , but their mechanism of action at cellular level is still not clear. Thus there is considerable research interest to look in anti-proliferative, pro-apoptotic, anti-inflammatoryand anti-angiogenic activity. identification of determine mechanism of action of UNIM formulation at cellular level using in vitro model on the in traditional medicine which are being used   since centauries.other anti-inflammatory agents especially those which are being used in traditional medicine since centauries.Unani system of medicine has rich treasure of therapeutically active anti-inflammatory products and extensive patient beneficial clinical experience on many chronic diseases. However there is lack of any mechanistic study and their effect at cellular level, which can be best explained by using the in-vitro cell model. Herbs, such as Rheum  palmatum L, Rehmannia glutinosa Libosch and Lonicera japonica have been used for the treatment of skin inflammatory diseases including psoriasis and atopic dermatitis, but their mechanism of action at cellular level is still not clear . Unani system of medicine has therapeutically active anti-inflammatory Products such UNIM 401, a novel polyherbal concoction of these 3 herbs in the ratio of 1:1:3, which demonstrated efficacious effects in the treatment of psoriasis. These findings encouraged us to determine mechanism of action of UNIM 401 at cellular level using in vitro models and assessing effect on the key markers of psoriasis.

The study focuses on the complex interactions between genetic predisposition and epigenetic alterations involved in pathogenesis of psoriasis . Objective of the study is to evaluate the effect  of serum NO, IL-22, TNF-α, IFN-γ, IL-6, sPLA2,VEGF levels in Psoriasis patients and follow-ups  taking  UNIM 401 formulation  compared to healthy controls

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with clinically diagnosed Psoriasis and healthy controls with matched temperament.
  • Age: 20-50 years.
  • With any duration of the disease, site, extension and distribution of the lesions.
  • Willingness to give written informed consent form.

排除标准

  • Subjects with Psoriasis treatment with other drug /systems.
  • History of drug or alcoholic abuse, chronic smokers not willing to abstain from smoking during the study period.
  • Any clinically significant abnormality identified on physical examination/laboratory tests.
  • Subjects having any systemic disease and other skin diseases.
  • Subjects with known allergies.
  • Impaired cardiac, hepatic and renal function.
  • History of malignancy.
  • Concomitant use of any other antioxidants.
  • Pregnant and other lactating women.

结局指标

主要结局

The present study will provide an understanding about the cellular level via multiple arms (ant proliferative, pro-apoptotic, anti-inflammatory, anti-antigenic) of UNIM formulation (UNIM401).

时间窗: 3 years

It also provides insight into mechanism of action of formulation & highlights its promising potential for development as an herbal therapeutic agent for psoriasis, emphasizing the need of further pharmacological evaluation & toxicological studies

时间窗: 3 years

次要结局

  • The present study will provide an understanding about the cellular & molecular mechanism of Unani formulation (UNIM 401) being used for treatment of various diseases from centuries keeping in mind the Unani Philosophy.(Further the study will help in validation of their safety and anti-inflammatory properties. Exploration of cellular and molecular mechanism involved in anti-inflammatory properties and the scientific validation in terms of mechanistic study for Unani drug will help to create an evidence based data and will pave the way for acceptability of these drugs globally)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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