Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608461
Status:
UNKNOWN
Last Update Posted:
2020-10-29
First Post:
2020-10-03
Brief Title:
Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arsenicosis is a major health problem in Bangladesh Long term exposure of arsenic causes keratosis of palm which reduce working capacity of patient It also causes massive skin lesions like Bowens disease which has a risk to develop squamous cell carcinoma Pumpkin seed is well known for its antioxidant and anticancer properties So this study will be conducted to identify the compound from pumpkin seeds and to see its outcome on keratosis
Detailed Description:
Contamination of groundwater by arsenic is a global problem affecting thousands of people worldwide especially in Bangladesh India and West Bengal In Bangladesh an estimated 59 administrative districts out of 64 have been affected with significantly high concentrations of arsenic Due to arsenicosis keratosis of palm and sole reduce the patients working capacity and affect the socioeconomic condition Bowens disease squamous cell carcinoma and basal cell carcinoma which are invasive skin lesions also caused by arsenicosis Keratosis can be treated by various topical preparations like salicylic acid alpha-lipoic acid zinc propylene glycol garlic oil neem leaf extract an extract of Azadirachta indica and Solanum melongena But these treatments require a longer time to relieve symptoms and thus reduce patients compliance Pumpkin seeds are rich not only in antioxidant vitamins carotenoids and tocopherols minerals and proteins but also low in fat and calories β-carotene reduces the damage of skin from the sun and it also acts as an anti-inflammatory agent α-carotene slows the aging process prevents tumor growth and reduces the risk of developing cataracts Vitamin E also called tocopherols protects the cell from oxidative damage by preventing oxidation of cell membranous unsaturated fatty acid β-sitosterol also useful to reduce blood cholesterol and to decrease the risks of some types of cancers So this study will be conducted to see the outcome of pumpkin seed extract in moderate to severe palmar arsenical keratosis The study will be an open phase-II clinical trial and will be conducted in Bangabandhu Sheikh Mujib Medical University and Sirajdikhan Upazila of Munshiganj District Extract from pumpkin seeds will be collected by using 70 ethanol as a solvent and rotary evaporator Thin Layer Chromatography TLC of extract will be done to identify the compound By using brine shrimp bioassay cytotoxicity assay will be done The ointment will be prepared from pumpkin seeds extract and supplied to each patient at an interval of 2 weeks Each patient will be advised about applying the cream Improvement and adverse effects will be monitored through phone calls and during the visit regularly Clinical improvement will be assessed by measuring the palmar arsenical nodule size before and after completion of treatment and perception of patients about their improvement Statistical analysis and results will be documented in different diagrams and in tabulated forms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None