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Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis

Primary Purpose

Keratotic Nodular Size

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Pumpkin seed extract containing cream
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratotic Nodular Size

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of moderate to severe palmar arsenical keratosis
  • Drinking arsenic contaminated water for at least six months
  • Patient voluntarily agreed to participate

Exclusion Criteria:

  • Age less than 19 years or more than 65 years
  • Pregnant and nursing mother
  • Skin diseases like atopic dermatitis eczema and psoriasis

Sites / Locations

  • SirajdikhanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pumpkin seeds extract containing cream

Arm Description

Intervention-pumpkin seeds extract containing cream, dose-twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Keratotic nodular size
Nodular size and lesion size will be measured by slide calipers

Secondary Outcome Measures

Full Information

First Posted
October 3, 2020
Last Updated
October 28, 2020
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04608461
Brief Title
Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis
Official Title
Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
December 5, 2020 (Anticipated)
Study Completion Date
December 5, 2020 (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

5. Study Description

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 Bowen's 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 patient's working capacity and affect the socioeconomic condition. Bowen's 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 patient's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratotic Nodular Size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pumpkin seeds extract containing cream
Arm Type
Experimental
Arm Description
Intervention-pumpkin seeds extract containing cream, dose-twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pumpkin seed extract containing cream
Intervention Description
Pumpkin seeds extract, white wax, white petrolium, stearyl alcohol
Primary Outcome Measure Information:
Title
Keratotic nodular size
Description
Nodular size and lesion size will be measured by slide calipers
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of moderate to severe palmar arsenical keratosis Drinking arsenic contaminated water for at least six months Patient voluntarily agreed to participate Exclusion Criteria: Age less than 19 years or more than 65 years Pregnant and nursing mother Skin diseases like atopic dermatitis eczema and psoriasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rokshana Khatun, MBBS
Phone
01716732929
Email
rokshana.bsmmu@gmail.com
Facility Information:
Facility Name
Sirajdikhan
City
Munshiganj
ZIP/Postal Code
1540
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rokshana Khatun, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis

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