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CTRI Number  CTRI/2024/06/068896 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
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   Evaluating the safety and efficacy of Unani formulations in Psoriasis 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of SafÅ«f-i-ChobchÄ«nÄ« and Ravghan-i-Rāl in the Management of Taqashshur al-Jild (Psoriasis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sadiya Siddiqua 
Designation  P G 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  8885046530  
Fax    
Email  dr.siddiqua786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr 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  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sadiya Siddiqua 
Designation  P G 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  8885046530  
Fax    
Email  dr.siddiqua786@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  Department Of Moalajat, 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 
Dr Sadiya Siddiqua  National Research Institute Of Unani Medicine For Skin Disorders  OPD & IPD of Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders. A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038
Hyderabad
TELANGANA 		 8885046530

dr.siddiqua786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NRIUMSD, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.Psoralen(Oral) 2.Petroleum Jelly(Topical)  1.Psoralen(8 Methoxsalen): Dose:30mg alternate day after breakfast Duration : 08 Weeks Mode of administration: Oral 2.Petroleum Jelly Dose: Q.S Duration : 08 weeks Mode of administration: Local 
Intervention  SafÅ«f-i-ChobchÄ«nÄ« (Oral) and Ravghan-i-Rāl (Topical)  1.SafÅ«f-i-ChobchÄ«nÄ«: Dosage form: SafÅ«f (powder) Dose : 5 gms Twice daily after meals with water Duration : 08 Weeks Mode of administration : oral Composition of SafÅ«f-i-ChobchÄ«nÄ« : ChobchÄ«nÄ« (Smilax China Linn),Sana (Cassia Angustifolia ),Ushba Maghribi (Smilax Aristolochiifolia),Bisfayej (Polypodium Vulgare Linn),Suranjan (Colchicum Luteum ),Aftimoon (Cuscuta Reflexa),Gul-e-surkh (Rosa Damascena Mill),Sandal Safaid(Santalum Album ). 2.Ravghan-i-Rāl : Dosage form : liquid Dose :Q.S Duration : 08 Weeks Mode of administration : Local Composition : Roghan-e- Kunjad(Sesamum indicum linn ),Mom zard (Bees Wax ),Rāl (Vateria Indica linn). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of any sex aged between 18-60 years of age,
Patients clinically diagnosed with Taqashshur al-Jild (Psoriasis),
Psoriasis area severity index (PASI) ≥10%. 
 
ExclusionCriteria 
Details  Pregnant or Lactating Women,
Significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction,
Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies,
Patients with Psoriatic arthritis,
Erythrodermic psoriasis. 
 
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 
Change in mean PASI Score from baseline to 2nd,4th and 8th week post treatment  56 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Change in DLQI assessment will be done at 2nd,4th & 8th week post treatment  56 DAYS 
 
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/ Phase 3 
Date of First Enrollment (India)   14/10/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The reported prevalence of psoriasis in countries ranges between 0.09%-11.4% making psoriasis a serious global problem. In India the prevalence of psoriasis varies from 0.44-2.8%.The conventional therapy has a good effect but has its own side effects like nausea, hyperpigmentation, pruritis, photo toxicity with serious complications such as skin carcinoma, hepatotoxicity and also worsening of disease. There are several single as well as compound Unani drugs which are in use for centuries for effectively treating taqashshur al-jild but many of them have not been evaluated clinically on scientific parameters. keeping this in view, this Randomized, Parallel Group, Open Label, Active Controlled Clinical Study is designed to evaluate the safety and efficacy of SafÅ«f-i-ChobchÄ«nÄ« and Ravghan-i-Rāl in management of Taqashshur al-Jild(Psoriasis). participants fulfilling inclusion criteria and exclusion criteria will receive either test or control drug as per randomization, in test drug participants will start with SafÅ«f-i-ChobchÄ«nÄ« (orally) and Ravghan-i-Rāl (Topically), in control participants will start with Psoralen(orally) and petroleum jelly(Topically). At baseline,2nd week and last follow up laboratory investigations will be done. Duration of study is 08 weeks. 
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