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CTRI Number  CTRI/2020/03/024029 [Registered on: 18/03/2020] Trial Registered Prospectively
Last Modified On: 17/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Unani Treatment of Acne vulgaris  
Scientific Title of Study   Efficacy of Unani formulation in Busoore Labaniya (Acne vulgaris): An open labelled single arm clinical study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sultana Anjum 
Designation  P.G.Scholar 
Affiliation  National Institute Of Unani Medicine 
Address  Kottigepalya, magadi main road

Bangalore
KARNATAKA
560091
India 
Phone  8210523248  
Fax    
Email  sultana5480@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Muzafar Din Ahmad Bhat 
Designation  Lecturer 
Affiliation  National Institute Of Unani Medicine 
Address  Kottigepalya, magadi main road

Bangalore
KARNATAKA
560091
India 
Phone  9590366192  
Fax    
Email  drmuzaffar79@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sultana Anjum 
Designation  P.G.Scholar 
Affiliation  National Institute Of Unani Medicine 
Address  Kottigepalya, magadi main road.

Bangalore
KARNATAKA
560091
India 
Phone  8210523248  
Fax    
Email  sultana5480@gmail.com  
 
Source of Monetary or Material Support  
National institute of unani medicine 
 
Primary Sponsor  
Name  National institute of unani medicine 
Address  Kottigepalya, magadi main road. Bangalore 
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 
Sultana Anjum  National institute of unani medicine  Kottigepalya, magadi main road
Bangalore
KARNATAKA 
8210523248

sultana5480@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InsInstitutional Ethics Committee for Biomedical Research NIUM Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Paste of Murdar sang, Bora Armani, Roghan gul for local application   Murdar sang and Bora armani in equal quantity will be grinded into powder form and sieve through 100 no. mesh. Roghan gul (Q.S) will be added to this powder to make paste and stored in a jar. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1- Patients of age group 14-40years, Both genders.
2- Clinically diagnosed patients of Acne vulgaris.
3- Patients/ Guardians who agree to sign the informed consent form and follow the protocol
 
 
ExclusionCriteria 
Details  1- Patients who do not co-operate.
2- Age <14 and >40 years.
3- Patients having local wound and infection on face
4- Pregnant and lactating women.
5- Patient with systemic diseases like Diabetes Mellitus, hypertension.
6- Patients on corticosteroid therapy, anticonvulsant therapy, or taking OCP
7- Patient suffering from other concomitant disease like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Global Acne Severity Scale
photographs
Cardiff acne Disability index
 
Weekly for 4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in QOL
Erythema
Dryness
Peeling
Burning
Itching 
Weekly for 4 weeks 
 
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)   19/03/2020 
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  

Busoore Labaniya also known as “Acne vulgaris” is one of the most common dermatosesof teenagers and young adults. The permissive factor for the expression of the disease is the increase in sebum production by sebaceous glands after puberty. The clinical hallmark of acne vulgaris is the comedone, which may be closed (whitehead) or open (blackhead)

Busoore Labaniya (Acne vulgaris) is sufficiently common and often heralds the onset of puberty. The prevalence hits its peak during the middle-to-late teenaged period with more than 85% of adolescents affected. A prevalence of acne in women between ages 26 and 44yrs is to be 14%.It is characterized by seborrhea, open and closed comedones, erythematous papules, pustules and in more severe cases nodules, deep  pustules and pseudocysts.According to the Global Burden disease (GBD) study it affects 85% of young adult aged 12-25 years. Acne consistently represents  the top three most prevalent skin condition in the general population, as found in large  studies with in the UK,   FRANCE and the USA. It leads to significant morbidity associated with residual scarring and psychological disturbances such as poor self – image, depression, and anxiety, which leads to a negative impact on quality of life.

In conventional therapies, Busoore Labaniya is treated either pharmacologically or surgically. Pharmacological therapy includes topical application of retinoids or oral administration of antibiotics and anti-androgens, while surgical intervention includes incision and curettage of cysts.The long term use of these treatment modalities are often associated with certain side effects like erythema, irritation, peeling, burning, drying and bleaching of skin; use of isotretinoin has teratogenic effects and tetracycline causes gastrointestinal discomfort and diarrhea, etc. Therefore, there is a dire need to develop a safe and effective regimen for the management of Busoore Labaniya.

In view of high prevalence, side effect of drugs of conventional medicine, present study has been designed to validate the effect of paste in Busoore Labaniya (Acne Vulgaris). The ingredients of formulations are  Murdarsang, Bora Armani and Roghan gul. Function of Murdarsang is Jali (detergent), Akkal (corrosive), Mujaffif (desiccative), Muhallil (resolvent), Qabiz (astringent), Mukhrij balgham (expectorant). The function of Bora Armani is Jali (detergent), Mujaffif (desiccative), Muhallil (resolvent), Mukhrij belgham (expectorant), Gussal (lavage), Dafa-Taffun(antiseptic), Qabiz (astringent). The function of Roghan gul is Radah (derivative), Qabiz (astringent), Muhallil (resolvent), Mufattih (deobstruent), Musakkin (analgesics).


 
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