A clinical study to evaluate effectiveness of Unani formulations in Tinea

A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, STANDARD CONTROLLED CLINICAL STUDY TO COMPARE THE EFFICACY AND SAFETY OF UNANI FORMULATIONS- QURS-E- ASFAR(O) AND ROGHAN-I-NARJIL(L) WITH ITRACONAZOLE(O) AND TERBINAFINE(L) IN THE MANAGEMENT OF QÅªBÄ?(DERMATOPHYTOSIS) - PGDT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024765

Enrollment

Registered

2020-04-21

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: Group A: Study Group (Unani Drug Group): Qurs-i-Asfar (oral) Roghan-i-Narjil (local) Method of Preparation- The drug will be prepared in single batch on the guidelines and method of pre

Eligibility

Inclusion criteria

Inclusion criteria: The participants will be included in the study on the basis of the following criteria: 1.Circumscribed lesions having any of the following signs and symptoms on body and limbs: Presence of pruritus and burning, Presence of scales, Presence of central clearing, Erythematous papules. 2.Participants with positive mycology (KOH positive). 3.Participants of either sex in age group of 18-60 years

Exclusion criteria

Exclusion criteria: The following participants will be excluded: 1.Co-morbid conditions of the participants 2.Pregnant or Lactating Women 3.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 4.Known cases of Immuno-compromised states (HIV/ AIDS, etc.)/ Malignancies 5.Participants not willing to attend treatment schedule regularly 6.History of hypersensitivity to Itraconazole and Terbinafine. 7.Participants using the following medications: Systemic antifungal within 15 days of baseline visit. 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 point scale. 2.Conversion to Negative Mycology: The conversion of the treated lesions from positive mycology (KOH positive mount) at the base line to negative mycology (KOH negative mount) at the end of trial. Timepoint: At baseline, 2nd, 3rd and 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 point scale. 2.Conversion to Negative Mycology: The conversion of the treated lesions from positive mycology (KOH positive mount) at the base line to negative mycology (KOH negative mount) at the end of trial. Timepoint: At baseline, 2nd, 3rd and 4th followups

—

Secondary

Measure	Time frame
Haemogram, Urine: RE & ME, LFT, KFT, FPGTimepoint: At baseline and end of the trial	—

Countries

India

Contacts

Public ContactMohammad Nawab

National Research Institute of Unani Medicine for Skin Disorders

ccrumnawab@gmail.com8100992044

Outcome results

None listed

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