A clinical study to evaluate effectiveness of Unani formulations in Tinea
- Conditions
- Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2020/04/024765
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>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. <br/ ><br>Timepoint: At baseline, 2nd, 3rd and 4th followups <br/ ><br>
- Secondary Outcome Measures
Name Time Method Haemogram, Urine: RE & ME, LFT, KFT, FPGTimepoint: At baseline and end of the trial