Anti-psoriatic Activity of a Novel Polyherbal UNIM 401 Formulation

Phase 2

Not yet recruiting

Conditions: Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,

Registration Number: CTRI/2023/07/055205

Lead Sponsor: Central council for Research in Unani Medicine

Brief Summary: 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-Î±, IFN-Î³, IL-6, sPLA2,VEGF levels in Psoriasis patients and follow-ups taking UNIM 401 formulation compared to healthy controls

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): National Research Institute of Unani Medicine for Skin disorders
🇮🇳
Hyderabad, TELANGANA, India
National Research Institute of Unani Medicine for Skin disorders
🇮🇳Hyderabad, TELANGANA, India
Dr Tasleem Ahmad
Principal investigator
04023810246
tasleem786@rediffmail.com