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CTRI Number  CTRI/2023/07/055205 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 13/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Anti-psoriatic Activity of a Novel Polyherbal UNIM 401 Formulation  
Scientific Title of Study   Evaluation of In vitro Anti-psoriatic Activity of a Novel Polyherbal UNIM Formulation by Multiparametric Analysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTasleem Ahmad 
Designation  Research Officer(Biochemistry)SL-III 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Biochemistry and Cell and molecular biology lab (BCMB) National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD) A.G colony road, Hyderabad.500038
NRIUMSD opp. ESI Hospital erragadda
Hyderabad
TELANGANA
500038
India 
Phone  04023810246  
Fax  04023811495  
Email  tasleem786@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrTasleem Ahmad 
Designation  Research Officer(Biochemistry)SL-III 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Biochemistry and Cell and molecular biology lab (BCMB) National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD) A.G colony road, Hyderabad.500038
NRIUMSD staff opp. ESI Hospital erragadda
Hyderabad
TELANGANA
500038
India 
Phone  04023810246  
Fax  04023811495  
Email  tasleem786@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  DrTasleem Ahmad 
Designation  Research Officer(Biochemistry)SL-III 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Biochemistry and Cell and molecular biology lab (BCMB) National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD) A.G colony road, Hyderabad.500038
NRIUMSD opp. ESI Hospital erragadda
Hyderabad
TELANGANA
500038
India 
Phone  04023810246  
Fax  04023811495  
Email  tasleem786@rediffmail.com  
 
Source of Monetary or Material Support  
Central council for research in Unani medicine, ministry of AYUSH govt of India 
 
Primary Sponsor  
Name  Central council for Research in Unani Medicine 
Address  61-65, Institutional Area opp.D block Janakpuri New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tasleem Ahmad  National Research Institute of Unani Medicine for Skin disorders  Department of Biochemistry cell and molecular Biology, A.G.colony Road, Opp. ESI Hospital Erragadda
Hyderabad
TELANGANA 
04023810246
04023811495
tasleem786@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not Applicable 
Intervention  UNIM 401  500 mg capsule of UNIM 401 will be taken twice daily with water for six month 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. Pregnant and other lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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).

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  
Outcome  TimePoints 
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
 
3 years 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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-α, IFN-γ, IL-6, sPLA2,VEGF levels in Psoriasis patients and follow-ups  taking  UNIM 401 formulation  compared to healthy controls

 
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