| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arbinasiya79@gmail.com].
- 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.
- 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.’’ |