NCT04608461

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 3, 2020

Last Update Submit

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

EXPERIMENTAL

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

Drug: Pumpkin seed extract containing cream

Interventions

Pumpkin seeds extract, white wax, white petrolium, stearyl alcohol

pumpkin seeds extract containing cream

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Central Study Contacts

Rokshana Khatun, MBBS

CONTACT

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

Locations