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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02908581 |
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Date of registration:
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28/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis
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Scientific title:
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Randomized, Open Label Trial of Iron and Folic Acid on Change of Fungal Pattern |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02908581 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Priyanka Moitra, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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BSMMU |
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Name:
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Mir Misbahuddin, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BSMMU |
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Key inclusion & exclusion criteria
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Inclusion Criteria: (Patients)
- History of drinking arsenic contaminated water(>50 µg/L) for more than 6 months
- Patients having moderate palmar keratosis
- Patients those voluntarily agree to participate
Exclusion Criteria:
- Pregnant and lactating mother
- Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
- Patient under treatment of arsenicosis on Criteria:
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Arsenic Poisoning
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Intervention(s)
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Drug: Placebo
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Drug: Iron 150 mg and Folic acid 0.5 mg
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Primary Outcome(s)
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Changes in the type of fungus in skin surface
[Time Frame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]]
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Secondary Outcome(s)
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Scoring palmar arsenical keratosis
[Time Frame: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]]
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Secondary ID(s)
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BSMMU-010-CT
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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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