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
|
|
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
|
|
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 |