| CTRI Number |
CTRI/2022/10/046493 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
10/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
psoriasis treatment with unani medicine |
|
Scientific Title of Study
|
A CLINICAL MANAGEMENT OF DAUS SADAF/TAQASHUR-E-JILD (PSORIASIS) WITH UNANI MEDICINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Sofian Ahmed |
| Designation |
Pg Scholar |
| Affiliation |
Government Nizamia Tibbi college and General Hospital |
| Address |
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
6281001051 |
| Fax |
00 |
| Email |
sufiahmed87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Sofian Ahmed |
| Designation |
Pg scholar |
| Affiliation |
Government Nizamia Tibbi college and General Hospital |
| Address |
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
6281001051 |
| Fax |
00 |
| Email |
sufiahmed87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MA Faroqui |
| Designation |
Pg professor and HOD |
| Affiliation |
Government Nizamia Tibbi college and General Hospital |
| Address |
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Government Nizamia Tibbi college and General Hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9849139356 |
| Fax |
00 |
| Email |
dr.faroqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG DEPARTMENT OF MOALIJAT(GENERAL MEDICINE) GNTC HYDERABAD |
|
|
Primary Sponsor
|
| Name |
PG DEPARTMENT OF MOALIJAT GEN MEDICINE GOVT NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
| Address |
GOVT NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GOVTNIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
CHARMINAR,HYDERABAD,TELANGANA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SYED SOFIAN AHMED |
OP NO 122 DEPARTMENT OF MOALIJAT |
GOVT NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL
Hyderabad
TELANGANA |
6281001051
00
sufiahmed87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Decoction of unani Medicine (each drug 5 grams i.e cymbopogon-flexuosus,Cichorium intybus,Foeniculum vulgare,Capparis soinosa,Apium graveolens,Cuscuta reflexa,Polypodium vulgare,Fumaria offinalis for 21 days/od).
Tablet(QURS E SARTAN KHAFOORI 0NE TAB /BD for 30 days).
Ointment(composition-Dorena ammorium,commiphora mukul,aristolochia rutunda, bee wax) for local application . |
Each patient will be treated with decoction for 21 days followed by majun najah, qurs sartan khafoori and arq murakkab musaffi khoon for 30 days,ointment for local application for 51 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AUSPITZ SIGN POSITIVE
Patient suffering from plaque psoriasis with in 1 year |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating women
patient suffering from psoriasis more than(>) 1 year
Comorbidity patients(i.e D.M,CKD,CVA,IHD)
MENTALLY RETARD PATIENT
CA PATIENTS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PSAI(PSOIARIASIS AREA AND SEVERITY INDEX ) WILL BE USED BEFORE AFTER THE TREATMENT TO RULE OUT THE OUT COME |
51 DAYS TREATMENT FOR EACH PATIENT i.e(21 days medicated decoction od, 30 days blood purifiers bd) local application through out the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PSAI(PSOIARIASIS AREA AND SEVERITY INDEX ) WILL BE USED BEFORE AFTER THE TREATMENT TO RULE OUT THE OUT COME |
51 DAYS TREATMENT FOR EACH PATIENT i.e(21 days medicated decoction od, 30 days blood purifiers bd) local application through out the treatment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
DAUS’SADAF/TAQASHUR-E-JILD (PSORIASIS) Is a non
infective papulo sqamous skin disease, characterized by well defined Erythematous plaques with
shiny slivery scales.
Synonyms :- Unani : Dausadaf/Taqashur-e-jild
English
: Psoriasis
Hindi
: Chambal
In our Unani concept our Ancient physician
suggest that there might be excess accumulation of Abnormal sauda and safra
mutahirqa(jala huwa safra) into the skin.
One of our famous Unani physician BUQRAT (HIPPOCRATES,
372-462 BC) Describe the skin disease but not specifies the term Psoriasis but
mentioned similar Sign and Symptoms of Psoriasis.
JALINOS (129-200 year) and IBN-E-RASHED
(1126-1198 year) stated that the Daus’sadaf (psoriasis) is a type of leprosy
and also desribed that excess quantity of Abnormal black bile caused chronic
skin disease such as Daus’sadaf & leprosy.
There are two key factors which play a
important role in aetiology of Psoriasis
1. Autoimmune:- Naïve T cells, IL12 & IL23
2. Genetic factors:- Family history found upto
30%
HLA-BW17- High familal tendency
HLA-BW13- Appear to have mild effects & h/o
Streptococcus infection
HLA-BW22- Strongly Associated with Psoriasis
HLA-BW38- with exhibiting Psoriasis &
distal Arthritis.
Triggering factors includes:- stress, trauma,
allergens, medication reactions.
Many changes occur in the skin
Epidermis:-
Acanthosis:- Increase thickness of stratum
spinosum & granulosum seen in psoriasis.
Parakeratosis:- nucleated cells seen stratum
corneum.
Dermis:-
Capillaries are dilated, twisted, closer to the
surface of the skin.
Large number of inflammatory cells are present
in all layers of the skin.
Langerhan cells and lymphocytes are also
increased.
The main abnormality is the increased epidermal
cell turn over.
|