Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02238912 |
Date of registration:
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10/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai
KR |
Scientific title:
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Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial |
Date of first enrolment:
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June 2012 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02238912 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients clinically diagnosed with tinea infection.
- direct microscopy skin scraping test positive.
Exclusion Criteria:
- pregnant or nursing women.
- use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs
either currently or during 2 weeks preceeding initiation of drug trial.
- allergy or hyperensitivity to any component of the drug.
- clinical case of eczema, lichen planus, pityriasis versicolor, drug induced
eruptions, urticaria, intertrigo, tinea ungium.
- diabetic patients.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied
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Intervention(s)
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Drug: kandhaga rasayanam
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Primary Outcome(s)
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skin scrapping test
[Time Frame: 45 days]
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Secondary Outcome(s)
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itching, quality of life
[Time Frame: 45 days]
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Secondary ID(s)
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EXII(1)/29097/2011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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