- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635853
Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hazera Sharmin, MBBS
- Phone Number: 01751926017
- Email: sharminhazera@gmail.com
Study Contact Backup
- Name: Kazi Moshiur Rahman, MSc
- Phone Number: 01789507952
- Email: razsbl1981@gmail.com
Study Locations
-
-
Muradnagar
-
Comilla, Muradnagar, Bangladesh, 3540
- Recruiting
- Kamalla, community clinic
-
Contact:
- Hazera Sharmin, MBBS
- Phone Number: 01751926017
- Email: sharminhazera@gmail.com
-
Contact:
- Shamima Akter
- Phone Number: 01921594068
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: patients with palmar arsenical keratosis
patients are given an ointment containing extract from cock's comb twice daily for three months
|
a container containing 25 mg of ointment having extract from cock's comb as active ingredient two times daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in keratotic nodular size
Time Frame: three months
|
palmar arsenical keratosis will be measured before and after applying interventions
|
three months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hazera Sharmin, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No. BSMMU/2018/2966
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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