A Clinical Study to compare unani formulation with benzoyl peroxide cream for 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 (5 Percent) 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/2025/11/097575

Enrollment

Registered

2025-11-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Interventions

Intervention1: Topical Unani Formulation: Composition:Kaf e Darya-1Part Haldi-1Part Method Of Prepration:The drug will be prepared as per the guidelines spe

Eligibility

Inclusion criteria

Inclusion criteria: The following Participants will be included in the study: a) Participants of any sex in the age group between 14 and 40Years b)Clinically stable patients c) Participants having the following signs & symptoms of Buthur Labaniyya: Comedones Papules Pustules Nodules Itching Erythema

Exclusion criteria

Exclusion criteria: The following Participants will be excluded from the study: a)Participants aged Less then 14 years or More then 40 years b)Pregnant or Lactating Women c) Mentally retarded person d)Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives e)Patients suffering from other concomitant diseases, like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema,etc. f)Significant Pulmonary,Cardiovascular,Hepato-renal Dysfunction. g)Patient not willing to attend treatment schedules regularly.

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures 1. Change in Global Acne Grading System (GAGS) Score from baseline to 6 weeks of treatment 2. Change in Cook s Acne Grading Scale (CAGS) Score from baseline to 6 weeks of treatment 3. Change in Patient s Global Assessment (PGA) on VAS from baseline to end of 6 weeks 4. Change in Period of Clinical Recovery from baseline to week 6Timepoint: Participants will be followed-up for evaluation at 2, 4, & 6 weeks	—

Measure

Time frame

Primary Outcome Measures 1. Change in Global Acne Grading System (GAGS) Score from baseline to 6 weeks of treatment 2. Change in Cook s Acne Grading Scale (CAGS) Score from baseline to 6 weeks of treatment 3. Change in Patient s Global Assessment (PGA) on VAS from baseline to end of 6 weeks 4. Change in Period of Clinical Recovery from baseline to week 6Timepoint: Participants will be followed-up for evaluation at 2, 4, & 6 weeks

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Secondary

Measure	Time frame
1.Evaluation of Safety by: a.Monitoring Adverse Events (AEs): Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2, 4, and 6 week both as reported by the participants, and observed by the physician during clinical examination. b.Changes in Laboratory Parameters (performed at baseline and at week 6) -Haemogram( Hb, TLC, DLC, RBC Count, Platelet Count, ESR,FBS) -Liver Function Test (Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase) -Kidney Function Test (Serum Creatinine, Blood Urea) -Urine Examination (Routine & Microscopic) 2.Change in DLQI score from baseline to week 6 Timepoint: Follow up at 2 And 6week	—

Measure

Time frame

1.Evaluation of Safety by: a.Monitoring Adverse Events (AEs): Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2, 4, and 6 week both as reported by the participants, and observed by the physician during clinical examination. b.Changes in Laboratory Parameters (performed at baseline and at week 6) -Haemogram( Hb, TLC, DLC, RBC Count, Platelet Count, ESR,FBS) -Liver Function Test (Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase) -Kidney Function Test (Serum Creatinine, Blood Urea) -Urine Examination (Routine & Microscopic) 2.Change in DLQI score from baseline to week 6 Timepoint: Follow up at 2 And 6week

—

Countries

India

Contacts

Public ContactDr Shaikh Nazia Rashid Ahmed

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad

qamaruddindr@gmail.com8700027178

Outcome results

None listed

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