Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
Primary Purpose
Improvement of Keratotic Nodular Size
Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
drug containing extract from cock's comb
Sponsored by
About this trial
This is an interventional treatment trial for Improvement of Keratotic Nodular Size
Eligibility Criteria
Inclusion Criteria:
- drinking arsenic contaminated water (>50 microgram/litre) for more than 6 months patients with moderate to severe arsenical palmar keratosis patients voluntarily agreed to participate patient did not receive topical application of any drug for the last three months
Exclusion Criteria:
- patient who received any treatment of arsenicosis within last three months patient with diagnosed skin disease, like-atopic dermatitis and psoriasis any diagnosed systemic diseases, inflammatory disease and infectious condition that affect the skin, for example- diabetes mellitus, SLE and hepatitis
Sites / Locations
- Kamalla, community clinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with palmar arsenical keratosis
Arm Description
patients are given an ointment containing extract from cock's comb twice daily for three months
Outcomes
Primary Outcome Measures
changes in keratotic nodular size
palmar arsenical keratosis will be measured before and after applying interventions
Secondary Outcome Measures
Full Information
NCT ID
NCT03635853
First Posted
August 16, 2018
Last Updated
August 16, 2018
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT03635853
Brief Title
Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
Official Title
Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Arsenicosis is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to arsenicosis which is characterized by dermatological features i.e. diffuse melanosis , spotted melanosis and keratosis. Cock's comb is rich in hyaluronic acid, chondroitin sulfate A, B, C and heparin. Hyaluronic acid is a hydrophilic molecules and is a constituent of wound extracellular matrix and facilitate wound healing.This work is aimed to identify the component that is effective in palmar arsenical keratosis.
Detailed Description
Groundwater contamination caused by inorganic arsenic is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to chronic arsenic poisoning which is characterized by dermatological features i.e. diffuse melanosis followed by spotted melanosis hyperpigmentation and keratosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improvement of Keratotic Nodular Size
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
a single group of patients with palmar arsenical keratosis are given the drug, under study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with palmar arsenical keratosis
Arm Type
Experimental
Arm Description
patients are given an ointment containing extract from cock's comb twice daily for three months
Intervention Type
Drug
Intervention Name(s)
drug containing extract from cock's comb
Intervention Description
a container containing 25 mg of ointment having extract from cock's comb as active ingredient two times daily for 3 months
Primary Outcome Measure Information:
Title
changes in keratotic nodular size
Description
palmar arsenical keratosis will be measured before and after applying interventions
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
drinking arsenic contaminated water (>50 microgram/litre) for more than 6 months patients with moderate to severe arsenical palmar keratosis patients voluntarily agreed to participate patient did not receive topical application of any drug for the last three months
Exclusion Criteria:
patient who received any treatment of arsenicosis within last three months patient with diagnosed skin disease, like-atopic dermatitis and psoriasis any diagnosed systemic diseases, inflammatory disease and infectious condition that affect the skin, for example- diabetes mellitus, SLE and hepatitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazera Sharmin, MBBS
Phone
01751926017
Email
sharminhazera@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kazi Moshiur Rahman, MSc
Phone
01789507952
Email
razsbl1981@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazera Sharmin, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamalla, community clinic
City
Comilla
State/Province
Muradnagar
ZIP/Postal Code
3540
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazera Sharmin, MBBS
Phone
01751926017
Email
sharminhazera@gmail.com
First Name & Middle Initial & Last Name & Degree
Shamima Akter
Phone
01921594068
12. IPD Sharing Statement
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Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
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