Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
NCT ID: NCT03635853
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2017-09-16
2019-02-28
Brief Summary
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Detailed Description
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Until now there is no internationally accepted treatment for arsenical keratosis. Some authors suggest long-term administration of vitamin and mineral and topical application of salicylic acid, propylene glycol and neem may be effective. Cock's comb extract contains hyaluronic acid, chondroitin sulfates A, B and C, heparin, hexosamine and water. Study with cock's comb extract in the treatment of arsenical keratosis was done in the Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University and was found effective. Therefore, the purpose of this study will be identification of compound isolated from cock's comb and its effect on palmar arsenical keratosis. After obtaining Institutional review board clearance, on the basis of inclusion and exclusion criteria, 40 patients with moderate to severe palmar arsenical keratosis will be enrolled from arsenic affected area located at Kamalla Union of Muradnagar Upazilla, Comilla. The study will be open phase II clinical trial. After enrollment, patients will be informed about the purpose as well as harmful and beneficial effects of the study. Informed written consent, detail history, clinical examination, photographs of the palm and water and nail samples will be collected before starting recruitment to confirm arsenicosis. For identification of compound present in the cock's comb thin layer chromatography and nuclear magnetic resonance will be done. Cytotoxic effects of the cock's comb extract will be analyzed by using brine shrimp assay. Cream will be prepared from cock's comb extract and supplied to the patient at an interval of 2 weeks to apply on palmar keratotic nodule with clean fingertip by rubbing gently at night for 12 weeks. Adherence of the cream and side effects will be monitored routinely through phone and during visit at field level. Improvement will be assessed by measuring the palmar keratotic nodular size with the help of slide calipers. The mean score of the nodular size before and after treatment will be done. Statistical analysis will be conducted by paired t test. The result will be presented in tabulated forms and bar diagrams.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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patients with palmar arsenical keratosis
patients are given an ointment containing extract from cock's comb twice daily for three months
drug containing extract from cock's comb
a container containing 25 mg of ointment having extract from cock's comb as active ingredient two times daily for 3 months
Interventions
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drug containing extract from cock's comb
a container containing 25 mg of ointment having extract from cock's comb as active ingredient two times daily for 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Responsible Party
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Dr. Hazera Sharmin
Resident, Dept. of Pharmacology
Principal Investigators
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Hazera Sharmin, MBBS
Role: PRINCIPAL_INVESTIGATOR
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Locations
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Kamalla, community clinic
Comilla, Muradnagar, Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Shamima Akter
Role: backup
Other Identifiers
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No. BSMMU/2018/2966
Identifier Type: -
Identifier Source: org_study_id
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