Evaluating Efficacy of Unani Formulation in Tinea

A Randomized, Parallel Group, Open Label, Standard Controlled Clinical Study to Compare the Efficacy and Safety of Unani Formulation - Roghan-i Zarneekh (T) with Luliconazole (T) in the Management of QÅ«bÄ? (Dermatophytosis)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/036043

Enrollment

Registered

2021-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: Roghan-i Zarneekh (T): Oil will be applied topically on the affected parts twice daily Duration of therapy: 4 weeks Control Intervention1: Luliconazole cream 1% (T): Method of Applicati

Eligibility

Inclusion criteria

Inclusion criteria: The partcipants will be included in the study on the basis of the following criteria: i. Participants with positive mycology (KOH positive) ii. Circumscribed lesions having any of the following signs and symptoms on trunk and inguinal region: a. Presence of pruritus and burning b. Presence of scales c. Presence of central clearing d. Erythematous papules

Exclusion criteria

Exclusion criteria: The partcipants will be excluded: i. Co-morbid conditions of the participants ii. Pregnant or Lactating Women iii. Significant pulmonary/ cardiovascular/ hepatorenal dysfunction iv. Known cases of Immuno-compromised states (HIV/ AIDS, etc.), malignancies v. History of Hypersensitivity to Luliconazole vi. Participants not willing to attend treatment schedule regularly vii. Participants using the following medications: a. Systemic antifungal within 15 days of baseline visit b. Systemic corticosteroids within 15 days of baseline visit

Design outcomes

Primary

Measure	Time frame
1.Total Signs and Symptoms Score (TSSS):The efficacy of the test drug will be assessed on the basis of clinical signs and symptoms on each follow-up, which will be rated on four-point scale. 2.Conversion to Negative Mycology: The conversion of the treated lesions from positive mycology (KOH positive mount) at the baseline to negative mycology (KOH negative mount) at the end of treatment. Timepoint: At baseline, 1st, 2nd, 3rd, 4th followups.	—

Measure

Time frame

1.Total Signs and Symptoms Score (TSSS):The efficacy of the test drug will be assessed on the basis of clinical signs and symptoms on each follow-up, which will be rated on four-point scale. 2.Conversion to Negative Mycology: The conversion of the treated lesions from positive mycology (KOH positive mount) at the baseline to negative mycology (KOH negative mount) at the end of treatment. Timepoint: At baseline, 1st, 2nd, 3rd, 4th followups.

—

Secondary

Measure	Time frame
Hemogram, Urine: RE & ME, LFT, KFT, FPG.Timepoint: At baseline and end of the trial.	—

Countries

India

Contacts

Public ContactDr Arzeena Jabeen

National Research Institute of Unani Medicine for Skin Disorders

aarzu763@gmail.com9032519286

Outcome results

None listed

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