Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2019
CompletedFirst Submitted
Initial submission to the registry
October 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2020
CompletedOctober 29, 2020
October 1, 2020
1.2 years
October 3, 2020
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Keratotic nodular size
Nodular size and lesion size will be measured by slide calipers
12 weeks
Study Arms (1)
pumpkin seeds extract containing cream
EXPERIMENTALIntervention-pumpkin seeds extract containing cream, dose-twice daily for 12 weeks
Interventions
Pumpkin seeds extract, white wax, white petrolium, stearyl alcohol
Eligibility Criteria
You may qualify if:
- Presence of moderate to severe palmar arsenical keratosis
- Drinking arsenic contaminated water for at least six months
- Patient voluntarily agreed to participate
You may not qualify if:
- Age less than 19 years or more than 65 years
- Pregnant and nursing mother
- Skin diseases like atopic dermatitis eczema and psoriasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sirajdikhan
Munshiganj, 1540, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MBBS, MD ( Phase- B ), Resident
Study Record Dates
First Submitted
October 3, 2020
First Posted
October 29, 2020
Study Start
September 17, 2019
Primary Completion
December 5, 2020
Study Completion
December 5, 2020
Last Updated
October 29, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share