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CTRI Number  CTRI/2025/02/080103 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
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   Treatment of Acne Vulgaris with Topical Unani Compound Formulation  
Scientific Title of Study   Assessing the Therapeutic effects of Topical Unani Compound Formulation for Treating Acne Vulgaris (Buthur-e-labaniyya): Randomized, Standard-Controlled Clinical Trial. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asiya Arbin 
Designation  PG Scholar 
Affiliation  Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101 
Address  Department of Moalajat ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
5886101
India 
Phone  7019996839  
Fax    
Email  arbinasiya79@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Qudrathullah Khan 
Designation  Professor HOD Moalajat LUMC Vijaypura 
Affiliation  Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101 
Address  Department of Moalajat ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  9849438319  
Fax    
Email  drmqkhan@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saba Mamdapur 
Designation  Professor, Dept. of Moalajat LUMC Vijaypur, 
Affiliation  Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101 
Address  Department of Moalajat ground floor Luqman Unani Medical College Hospital and Research Centre VijayaPura Karnataka 586101

Bijapur
KARNATAKA
586101
India 
Phone  9611497816  
Fax    
Email  dr.sabamamdapur@gmail.com  
 
Source of Monetary or Material Support  
Luqman Unani Medical College Hospital and Research Center 12 Naubag, Vijayapura (Bijapur), Karnataka 586101 
 
Primary Sponsor  
Name  Luqman Unani Medical College Hospital and ResearchCenter 
Address  12 Naubag, Vijayapura (Bijapur),Karnataka 586101 
Type of Sponsor  Private medical college 
 
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 Asiya Arbin  Luqman unani medical college hospital and research centre  Ground floor Room no.1,General OPD ,Department of Moalajat,Luqman Unani Medical College Hospital and Research Centre Vijayapura Karnataka 586101
Bijapur
KARNATAKA 
7019996839

arbinasiya79@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethical Committee (IEC) For Bio Medical Research  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  Benzoyl peroxide 5% gel  Form Gel Mode of application Topical Contact period 20 to 30min Dosage Quantity sufficient once daily Follow up: 30th, 60th & 90th day 
Intervention  Powder of Kalonji (Nigella sativa)and Anjeer (Ficus carica Linn.) mixed with Sirka (vinegar).   Form Zimad (Cream) Mode of application Topical Dosage Quantity sufficient once daily Contact period 20 to 30min Follow up 30th 60th & 90th day Method of preparation Nigella sativa (Kalonji) Ficus carica Linn. (Anjeer) and vinegar (Sirka) will be sourced from certified herbalists and chemists A qualified botanist will conduct taxonomic identification of Kalonji and Anjeer Afterwards the dried Kalonji and Anjeer will be finely ground using a mortar and pestle then sifted through mesh no. 80. This powder will be blended with vinegar until a uniform paste is formed, which will be applied to the affected area of the skin.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  participants with comedones, papules,pustules,nodules,itching and erythema
participants willing for written voluntary consent. 
 
ExclusionCriteria 
Details  1 Patient with other associated disorders like acne rosacea, acne fulminans, acne necrotica,
psoriasis, eczema etc.
2 Patient on corticosteroid therapy, Anticonvulsant therapy, or taking oral contraceptive
pills for last 1 month.
3 Pregnant and lactating women.
4 Patients suffering with other previously diagnosed severe systemic illness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Global Acne Grading System (GAGS)
Cook’s Acne Grading Scale (using photographic standards)
 
baseline 30th 60th and 90th  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life by Cardiff Acne Disability Index (CADI)  Baseline and After Trial  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/02/2025 
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="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arbinasiya79@gmail.com].

  6. For how long will this data be available start date provided 03-02-2027 and end date provided 02-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nill
Brief Summary  
Acne vulgaris is a prevalent condition affecting the pilosebaceous unit, typicallyobserved in adolescents. The majority of acne cases manifest with a diverse range of lesions, including comedones, papules, pustules, and nodules, which can vary inseverity and extent. [1] Acne impacts almost all individuals aged 15 to 17 years, with moderate to severe cases observed in 15-20% of young individuals. The highest occurrence is typically seen between ages 15 to 20 across various ethnicities. Historical studies indicate a trend where males tend to experience more severe acne during late adolescence compared to females.[2]
Acne is characterized by four primary mechanisms: elevated sebum production, follicular hyper-keratinization, colonization by Propionibacterium acnes (P. acnes), and inflammatory responses.[3] A range of therapeutic options exists for treating acne, encompassing both topical and systemic modalities. Topical agents such as benzoyl peroxide, antibiotics, and retinoids are commonly used either individually or in combination to target various aspects of the condition, such as sebum production and inflammation. Systemic therapies, including oral antibiotics, hormonal treatments, and isotretinoin, are considered for more severe cases or when topical treatments prove inadequate. Physical treatments like lesion removal and phototherapy offer additional avenues for management.[3] However, it’s crucial to note that some therapies, particularly systemic retinoids like isotretinoin, carry significant risks, especially concerning teratogenicity, particularly when administered early in pregnancy. Potential foetal deformities associated with retinoid use include malformations of the central nervous system, craniofacial abnormalities, heart defects, and issues with the thymic or parathyroid glands. Therefore, it’s important to educate women of childbearing age about the importance of effective contraception when undergoing such treatments.[4] Topical medications, while effective in reducing severity and preventing scarring, can also lead to undesirable effects such as skin dryness, redness, burns, and potential recurrence of acne. [5]
According to Unani literature, Ibn Sina described in Al Qanoon that Buthur-elabaniyya is identified by tiny white eruptions appearing on the face, nose, and cheeks, resembling concentrated droplets of milk. [6] Basoor are of different types. These basoor are classified in various types depending upon the involvement of humours (dam, balgham, safra, sauda) or reeh. These basoor may be hot or cold in temperament. Har (Hot) swellings are caused by har khilt (matter) or due to sue mizaj of other khilt. Hot swellings are classified according to the nature of morbid material. Disturbance of khilt dam (blood) as phlegmonous (phalgamoni) and of the bilious humor as erythematous (hamrah), and
term their combinations as phlegmonous erythema (Phalgamonihamrah) and erythematous phlegmon (hamrahphalgamoni) according to the dominant humor. Other basoor which are not har are caused by Sauda, balgham (phlegm), fluid, and reeh.[7]
In the Unani medical tradition, a variety of single and compound drugs have been employed to address Busoor Labaniya. These medications are regarded as safe and generally devoid of significant side effects. Agents possessing detergent, resolving, blood-purifying, and desiccative properties have been utilized in the treatment of Busoor Labaniya.[8] The primary for conducting this study was to address the necessity for a safe and efficient medication. Therefore, the selection of this study aimed ‘‘to evaluate the safety and effectiveness of a topical Unani compound formulation in treating Acne Vulgaris (Buthur-e-labaniyya), through a randomized, standard-controlled clinicaltrial.’’
 
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