Evaluating Efficacy of Unani Formulation in Tinea

Phase 2/3

Not yet recruiting

• Conditions: Local infection of the skin and subcutaneous tissue, unspecified,

• Registration Number: CTRI/2021/08/036043
• Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary

Title of the Study:

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)

Objectives of the Study:

To evaluate the efficacy of Roghan-i Zarneekh (T) as compared to an allopathic drug in the management of QÅ«bÄ (Dermatophytosis)



To evaluate the safety of Roghan-i Zarneekh (T) as compared to an allopathic drug in the management of QÅ«bÄ (Dermatophytosis)



Study Rationale (justification for conduct of this study)



The prevalence of QÅ«bÄ (Dermatophytosis) is 20- 25% worldwide. It also has many ill impacts on the patient’s quality of life. In conventional medicine, some antifungal drugs are used in the treatment of dermatophytosis, which are becoming resistant to the organism and also have certain adverse effects as headache, nausea, vomiting, abdominal pain, rashes, hepatotoxicity, hypokalaemia, oligozoospermia, etc. Hence, there is need to search drugs which may be effective and safe in the management of QÅ«bÄ (Dermatophytosis). Keeping this in view, a Unani formulation Roghan-i-Zarneekh has been selected to  evaluate its efficacy and safety in the management of QÅ«bÄ (Dermatophytosis).



Study Design:

Randomized, Standard Controlled, Parallel Group, Open Label Clinical Study

Inclusion Criteria

i. Participants of either sex in age group of 18-60 years

ii. Participants with positive mycology (KOH positive)

iii. 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

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



Sample Size 60 (Test Group = 30 & Control Group = 30)



Test Drug Roghan-i Zarneekh Local application

Control Drug  Luliconazole cream 1%  Local application



Duration of Treatment:  4 weeks



Investigations to be done ï‚· Haemogram: Hb, TLC, DLC, ESR

ï‚· Urine: RE & ME

ï‚· LFTs: SGOT, SGPT, S. Alkaline Phosphatase, S. Bilirubin

ï‚· KFTs: S. Creatinine and BUN

ï‚· Fasting Plasma Glucose (FPG)

ï‚· KOH Examination .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-09
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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

• 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.
• Systemic antifungal within 15 days of baseline visit b.
• Systemic corticosteroids within 15 days of baseline visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Conversion to Negative Mycology:	At baseline, 1st, 2nd, 3rd, 4th followups.
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.	At baseline, 1st, 2nd, 3rd, 4th followups.
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.	At baseline, 1st, 2nd, 3rd, 4th followups.

Secondary Outcome Measures

Name	Time	Method
Hemogram, Urine: RE & ME, LFT, KFT, FPG.	At baseline and end of the trial.

Trial Locations

Locations (1)

National Research Institute of Unani Medicine for Skin Disorders; 🇮🇳 Hyderabad, TELANGANA, India

National Research Institute of Unani Medicine for Skin Disorders

🇮🇳Hyderabad, TELANGANA, India

Kamal Ahmad

Principal investigator

8006363813

kamalahmad788@gmail.com