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Clinical study on a topical Unani formulation in Acne

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a topical Unani Formulation compared with Benzoyl Peroxide (2.5%) in the Management of Buthur Labaniyya (Acne Vulgaris) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065488
Enrollment
60
Registered
2024-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris Health Condition 2: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: Topical Unani Formulation: Alsi (Linum usitatissimum) will be powdered and mixed with Sirka (Vinegar) to make a paste for topical application in sufficient quantity on the affected site

Sponsors

National Research Institute of Unani Medicine For Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The following patients will be included in the study: 1. Participants of either gender in the age group between 15 to 35 years 2. Participants having any of the following symptoms of Buthur Labaniyya like Comedones, Papules, Pustules ,Nodules, Itching, Erythema 3. Participants willing to give consent or assent and attend follow-up visits regularly 4.Clinically stable patients

Exclusion criteria

Exclusion criteria: The following patients will be excluded: 1. Patients aged less than 15 years or more than 35 years 2. Participants with other variants of acne like acne fulminans, acne rosacea, acne necrotica. 3. Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives 4. Pregnant or Lactating Women 5. Significant Pulmonary/ Cardiovascular/ Hepato-renal Dysfunction and other Disorders requiring long-term treatment 6. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies ? Patient not willing to attend treatment schedule regularly.

Design outcomes

Primary

MeasureTime frame
Reduction in Global Acne Grading System (GAGS)Timepoint: 0,2 and 4 weeks

Secondary

MeasureTime frame
1. Patient’s Global Assessment (PGA) on VAS 2. Dermatology Life Quality Index (DLQI) ScoresTimepoint: 0 and 4 weeks

Countries

India

Contacts

Public ContactDR NAILA NAAZ

National Research Institute of Unani Medicine For Skin Disorders

drashfaque6@gmail.com9035268167

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026