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CTRI Number  CTRI/2023/03/050418 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 03/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized, Clinical Study to evaluate the Efficacy and Safety of Safoof-i-Ushba and Roghan-i-Banafsha in Taqashshur al-Jild (Psoriasis)  
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of Safoof-i-Ushba and Roghan-i-Banafsha in the Management of Taqashshur al-Jild (Psoriasis)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abdur Rahman Khan 
Designation  PG Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8574664018  
Fax    
Email  a.rahmanbums12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Professor Arzeena Jabeen 
Designation  Professor 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8574664018  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abdur Rahman Khan 
Designation  PG Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8574664018  
Fax    
Email  a.rahmanbums12@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038 
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 
Abdur Rahman Khan  National Research Institute of Unani Medicine for Skin Disorders  OPD of National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038
Hyderabad
TELANGANA 		 8574664018

a.rahmanbums12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of NRIUMSD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L408||Other psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Psoralen and Betamethasone valerate 0.12%  Dosage Form: Tablet and Cream Dose: 30mg tablet in single dose alternate day orally and cream for local application Duration: 12 weeks 
Intervention  Safoof-i-Ushba and Roghan-i-Banafsha  Dosage Form: Safoof(powder) and Roghan(oil) Dose: 6gm of Powder twice daily and roghan for LA Duration: 12 weeks Route of Administration: Oral and Locally composition of Drugs: Safoof Ushba 1 Ushba maghrabi (Smilex aristolochiaefolia Miller) 37.5gm 2 Revand khatai (Rheum officinale Ballon) 11.25gm 3 Jalapa (Ipomoea purga Hayne) 5.50gm 4 Sana makki (Cassia angustifolia Vahl) 22.50gm 5 Post haleela zard (Terminalia chebula Retz) 5.50gm 6 Post haleela kabuli (Terminalia chebula Retz) 5.50gm 7 Post baheda (Terminalia bellerica) 5.50gm 8 Haleela siyah (Terminalia chebula) 5.50gm 9 Gule surkh (Rosa damascena mill) 5.50gm 10 Barge shahtra (Fumaria officinalis) 4.50gm 11 Misri (Rock sugar) 54.37gm Roghan-i-Banafsha Banafsha (Viola odorata) 10 gm 2 Roghan Kunjad (Sesamum indicum) 50gm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient clinically stable.
2. Patient with clinically diagnosed Taqashshur al-jild (psoriasis) of
plaque type.
3. Psoriasis area severity index (PASI) ≥10% 
 
ExclusionCriteria 
Details  1. Participants aged <18and >60years
2. Known cases of significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
3. Erythrodermic psoriasis.
4. Pregnancy and Lactation.
5. Patient not willing to attend treatment regularly. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in Psoriasis Area Severity Index (PASI)
2. Improvement in Investigators Global Assessment (IGA)
3. Improvement in Patient’s Global Assessment (PGA) on VAS 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Systemic Safety Assessment  12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/03/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Psoriasis is a papulo-squamous disorder of the skin characterized by sharply defined red scaly lesion. They vary in size from pin point to large plaques. It is universal in occurrence and the incidence is 1 to 3 % of the world’s population. A family history is found in 300% of the patient. Taqashshur al-Jild is also defined as a type ofskin disease characterized by roughening and hardening of affected part of skin accompanied with sloughing of fish like scales and itching. Unani system of medicine is based on Humoral concept. According to this concept: psoriasis is a melancholic disorder caused by derangement of Khilṭ-i Sawda (morbid black bile) resulting from Ḥiddat and Taʻaffun-i Dam (impure blood). Taqashshur al-Jild (Psoriasis) is still incurable, Unani formulations, Safūf-I Ushba possesses Muṣaffī-i Dam (blood purifier) and Munzij wa Mush’il-i Sawda (concoctive and purgative of melancholic humor) and removal of bad humors actions, and Rogan i-Banafsha possesses soothing
actions, resolvent, sedative effects. After completion of the study, data obtained will be analyzed statistically by using an appropriate t  test to evaluate the significance of results. p<0.05 will be considered significant.
 
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