Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686474
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2020-12-23
Brief Title:
Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis
Status:
UNKNOWN
Status Verified Date:
2021-01
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:
Prepare an ointment from Azadirachta indica leaves extract and its apply on palmer arsenical keratosis patient for 12 weeks After intervention effect of the ointment will be observed by measuring the nodule before and after apply the ointment
Detailed Description:
Arsenicosis or arsenic toxicity caused by prolong ingestion of contaminated groundwater by inorganic arsenic more than 005 mgliter It is the severest natural calamity widespread specially in Bangladesh where 61 districts out of 64 are affected The commonest and earliest feature of arsenicosis is skin involvement like keratosis melanosis and skin carcinoma Keratosis of the palm and soles reduce the working ability of the patients and affect their socio-economic condition There is no specific treatment for keratosis Short-term improvement may occur by using some topical keratolytic like salicylic acid propylene glycol eating some dietary supplementation like vitamin A C E zinc folic acid and foodstuffs like corn spinach but symptoms recure after stoppage of these treatments Also these treatments require longer duration which ultimately affects patient adherence Azadirachta indica leaves contain flavonoids quercetin azadirachtin nimbin steroids alkaloids phenolic compounds and other biologically active compounds that have anti-proliferative anticarcinogenic antioxidative and immunostimulant effects For this reason a study named Effect of ethanol extract of leaves of Azadirachta indica on palmer arsenical keratosis A single-blind trial was done in the Department of Pharmacology Bangabandhu Sheikh Mujib Medical University which was found effective So the purpose of this study is to evaluate the effectiveness of the identified compound on moderate to severe arsenical keratosis which will be isolated from A indica leaves extract After IRB clearance 35 patients with moderate to severe arsenical keratosis will be collected based on inclusion and exclusion criteria from the arsenic affected area located at Kamalla Union of Muradnagar Upazilla Comilla The study will be quasi-experimental study Included patients will be informed about the purpose of this study as well as harmful and beneficial effects Informed written consent detail history clinical examination photographs of the palm and sole and nail samples will be collected before starting recruitment to confirm arsenicosis For identification of isolated compounds present in the A indica leaves thin layer chromatography nuclear magnetic resonance and infrared spectrometry will be done Cytotoxic effects of the A indica leaves extract will be assessed by using brine shrimp bioassay The ointment will be prepared from A indica leaves extract and supplied to the patient at an interval of 2 weeks Each patient will be advised to apply the ointment with a clean fingertip by rubbing gently in the morning and night for 12 weeks Regular monitoring will be done through phone calls and during a follow-up visit at the field level about improvement and side effects of the ointment Clinical improvement will be assessed by measuring the keratotic nodular size with the help of slide calipers Statistical analysis will be done by paired t-test
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