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CTRI Number  CTRI/2019/04/018665 [Registered on: 18/04/2019] Trial Registered Prospectively
Last Modified On: 16/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Antimicrobial Herbal soap develop for skin diseases. 
Scientific Title of Study   Design, development and evaluation of efficacy of anti-microbial soap. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tabassiya Kowser R 
Designation  P G Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Room no 4, Department of Jild, National Institute of Unani Medicine, Kottigepalaya, Magdi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  9629918474  
Fax    
Email  doctorkouser20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tabassiya Kowser R 
Designation  P G Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Room no 4, Department of Jild, National Institute of Unani Medicine, Kottigepalaya, Magdi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  9629918474  
Fax    
Email  doctorkouser20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roohi Zaman 
Designation  Professor 
Affiliation  National Institute of Unani Medicne 
Address  Dept of Ilmul Saidla, National Institute of Unani Medicine Kottigepalaya Magdi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  9448227053  
Fax    
Email  roohizaman62@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru, Karnataka 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Kottigepalaya, Magdi Main Road, Bengaluru 
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 
Tabassiyia Kowser R  National Institute of Unani Medicine  Room No 4 Dept of Jild, National Institute of Unani Medicine hospital, Kottigepalya, Magadi Main Road, Bengaluru
Bangalore
KARNATAKA 		 9629918474

doctorkouser20@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo   The affected area of the body with fungal infection will be washed twice daily with soap (placebo with soap base-100g)for thirty days 
Intervention  Unani formulation in soap form( haldi, neem, panwar powder)  The affected area of the body with fungal infection will be washed twice daily with soap (100g)for thirty days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with age group from 18 to 60 years
Both gender 
 
ExclusionCriteria 
Details  Age group – less than 18 and more than 60 years.
Diabetes, patients with known hypersensitivity to the drug, patients with severe skin infections, hypertension, Pregnancy, and lactation.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
KOH Examination of skin scrap (direct microscopy)
Photograph of the lesions
 		 KOH Examination of skin scrap (direct microscopy)will be taken before treatment and 30 days after treatment
Photograph of the lesions before treatment and 30 days after treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/05/2019 
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  
Skin infections are numerous and a frequently occurring health problem affecting all ages in number of ways. Skin infections occur in hot and warm humid climate that is characteristic of the tropics and many developing countries. Most skin infections are caused by microbes, chemical toxins, poor life style, infections present in atmosphere.A common symptom includes redness, rashes, pruritis, and pains. Diseases of the skin account for a great deal of misery, suffering, incapacity and economic loss. Besides this, they are a great handicap in the society, because they are visible. In clinical practice we encounter several patients suffering from chronic skin diseases like Dermatitis, Tineacorporis (ringworm), cellulitis, impetigo, erythema, urticaria, folliculitis, furunculosis, carbuncle, erysipelas, insect bites etc. which are treated with various antibacterial and antifungal agents. It not only affects the overall health of a patient but also their quality of life. In addition, they also suffer from side effects of standard treatments. 
Soap is described as a cosmetic preparation meant for washing of hand and face. In traditional medicine soaps are a very common vehicle for application of medicinal plants especially for external use and also for the treatment of skin diseases.Although there are several herbal soaps marketed in India but their complete formulation is generally not made available on the label, since there is no official quality control requirement for these products, their claims are questionable. Even though the Unani system has enormous literature of beauty products, still we do find bigger lacunae in the field of cosmetics. 
So, the present study deals with design and development of an herbal soap containing three drugs namely Neem, (AzadirachtaindicaA.Juss), Haldi(Curcuma longaLinn) and Panwar (Cassia tora Linn) which are easily available and proven as gold standard drugs for skin care mentioned in classical Unani literature. And to assess the antimicrobial properties of this soap against skin pathogens to justify their use in the management of various skin infections.
 
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