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CTRI Number  CTRI/2020/03/023697 [Registered on: 02/03/2020] Trial Registered Prospectively
Last Modified On: 01/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of the treatment of psoriasis by unani medicine 
Scientific Title of Study   A Randomized, Open-Label, Active Controlled, Parallel-Group Clinical Study to Compare the Safety and Efficacy of Itrifal Shahtra and Marham Hina with PUVAsol and Petroleum Jelly 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  Faiza Khatoon 
Designation  PG Scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine), National Research Institute of Unani Medicine for skin disorders(NRIUMSD), A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  6388104501  
Fax    
Email  faiza.khatoon32@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Qamar Uddin 
Designation  Professor 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders(NRIUMSD), A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arzeena Jabeen 
Designation  Lecturer 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders(NRIUMSD), A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038. 
 
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, Opp. 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 
Faiza Khatoon  National Research Institute of Unani Medicine for skin disorders  GOPD No.1 New Block National Research Institute of Unani Medicine for skin disorders(CRIUM), A.G. Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA 		 6388104501

faiza.khatoon32@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee NRIUM-SD Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group(A) Unani Drugs :Itrifal Shahtra and Marham Hina  Patient will be advised Itrifal Shahtra (semisolid) 6 gm twice daily with Water Orally and Marham Hina(Paste) 5gm will be applied locally on the affected site twice daily for 12 weeks 
Comparator Agent  PUVAsol and Petroleum Jelly  Patients will be given 8 MOP after meals on alternate days, in the dose of 20-40 mg followed by Sun exposure and apply petroleum jelly at night locally according to the affected area for 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1-Patients of any sex in the age group between 18 and 65 years
2-Patients with clinically diagnosed Taqashshur al-Jild (Psoriasis) of plaque-type
3-Psoriasis area severity index (PASI) of ≥10% 
 
ExclusionCriteria 
Details  1-Patients aged < 18 years or > 65 years
2-Pregnant and lactating mothers
3-Significant pulmonary/cardiovascular/hepato-renal dysfunction
4-Known cases of Immunocompromised states (HIV/ AIDS, etc.)
5-Patient not willing to attend treatment schedule regularly

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The response to treatment will be assessed using the following parameters:

1. Reduction in Psoriasis Area Severity Index (PASI)
2-Improvement in Investigators Global Assessment (IGA)
3-Patient’s Global Assessment (PGA) on VAS
 		 at base line,4wk,8wk,12wk 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement in quality of life in patients with Psoriasis by PGA ON VAS and IGA  at base line,4wk,8wk and 12wk 
 
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)   02/03/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Taqashshur al-Jild (Psoriasis) is a chronic inflammatory, hyperproliferative skin disease, characterized by well defined, erythematous scaly plaque, particularly affecting extensor surfaces, scalps and nails usually follows a relapsing and remitting course.It is twice more common in male compared to female population.
       In Unani classical literature, Taqashshur al-Jild is defined as a type of skin disease characterized by roughening and hardening of affected part of the skin accompanied by sloughing of fish-like scales and itching.
      The conventional therapies used for treatment of  Taqashshur al-Jild (Psoriasis) have a good effect but they have their own limitations and some reported side effects like nausea, hyperpigmentation, pruritus, phototoxicity with serious complications such as skin carcinoma, hepatotoxicity and also worsening of disease.
In the Unani System of Medicine, the main therapy of psoriasis includes drugs that purify the blood and normalize skin metabolism by strengthening its faculties. The primary goal of treatment in psoriasis is to relieve the discomfort by controlling the signs and symptoms. Since psoriasis is usually dry and itchy, most treatments involve the application of lotions, creams or ointment, oils to keep the skin as moist as possible.
       Unani formulations, ItrÄ«fal Shāhtra possess Muá¹£affÄ«-i Dam (blood purifier) and Munzij wa Mush’il-i Sawda’ (concoctive and purgative of melancholic humor)  and Murattib-i ‘UmÅ«mi (emollient) actions and Marham Hina possess emollient, Dāfi‘-i ‘UfÅ«nat (disinfectant), Musakkin-i Muqāmi (local Analgesic), Dāfi‘-iSozish (Anti pruritic), Dāfi‘-I Waram (Anti-inflammatory) action  respectively, but their efficacy and safety has yet to be proved on scientific parameters10,11.
Keeping the above facts in view, it has been planned to conduct “A Randomized, Open-Label, Active Controlled, Parallel-Group Clinical Study to Compare the Safety and Efficacy of Itrifal Shahtra and Marham Hina with PUVAsol and Petroleum Jelly in the Management of Taqashshur al-Jild (Psoriasis)”.
 
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