NCT04686474

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)

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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

October 20, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

December 23, 2020

Last Update Submit

January 7, 2021

Conditions

Keratotic Nodular Size

Outcome Measures

Primary Outcomes (1)

  • Keratotic nodular size

    Lesion size will be measured by slide calipers

    12 weeks

Study Arms (1)

Azadirachta indica leaves extract containing ointment intervention.

EXPERIMENTAL

Azadirachta indica leaves extract containing ointment will be used twice daily for 12 weeks

Drug: Azadirachta indica leaves extract containing ointment intervention.

Interventions

Azadirachta indica leaves extract containing ointment intervention.DRUG

Azadirachta indica leaves extract containing ointment, white petroleum, bee wax, stearyl alcohol

Azadirachta indica leaves extract containing ointment intervention.

Eligibility Criteria

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

You may qualify if:

  • to 65 years of age
  • Male and female both were included
  • Presence of palmar arsenical keratosis which nature was moderate to severe (2 to \>5)
  • Used water at least more than 6 months which was contaminated with arsenic (\>50 µg/L) especially for drinking purpose
  • Any drug like topical application did not received by the patient for at least last three month

You may not qualify if:

  • \<19 and \>65 years of age
  • Pregnant and breast feeding mother
  • Accept any treatment at least last three months for arsenicosis
  • Any type of skin disease like drug allergy, atopic dermatitis, psoriasis, eczema and other keratosis
  • Various systemic disease like diabetes mellitus, hepatitis, rheumatoid arthritis and others that affected the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muradnagar Upazilla

Comilla, Bangladesh

RECRUITING

Study Officials

  • Bangladesh Muradnagar Upazilla.Comilla

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Israt Zahan Zarin, MBBS

CONTACT

01729181559drisratzahan34@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Resident

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 28, 2020

Study Start

October 20, 2019

Primary Completion

January 20, 2021

Study Completion

February 20, 2021

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)