Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis

NCT04686461 | Unknown

• 1 other identifier: BSMMU/2020/1642
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Prepare an ointment from Nigella sativa seeds extract and apply it over palmer arsenical keratosis patient for 12 weeks. After than the effect of the ointment will be observed by measuring the keratotic nodular size before and after the intervention.

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)

Nigella sativa seeds extract containing ointment intervention

EXPERIMENTAL

Nigella sativa seeds extract containing ointment dose- twice daily for 12 weeks

Drug: Nigella sativa seeds extract containing ointment intervention

Interventions

Nigella sativa seeds extract containing ointment intervention DRUG

Nigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol

Nigella sativa seeds extract containing ointment intervention

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 19 - 65 years
• Arsenical keratosis: Presence of moderate to severe keratosis (\>5 mm) in both palms or soles
• Drinking arsenic-contaminated water (\>50 µg/ L) for at least more than six months
• Patient did not receive topical application of any drug for the last three months
• Patient agreed to participate voluntarily
• Patient who understood the instruction of applying drug and could apply drug as per an instruction

You may not qualify if:

• Age \<19 and \>65 years
• Pregnant and nursing mother
• Patient who received any treatment of arsenicosis within the last three months
• Patient with skin diseases like atopic dermatitis, eczema, and psoriasis
• Any systemic disease, inflammatory disease and infectious condition that affected the skin, for example, diabetes mellitus, rheumatoid arthritis, systemic lupus erythematosus and hepatitis
• Food allergy to Nigella sativa

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bhanga

Farīdpur, Bangladesh

RECRUITING

Study Officials

• Bangladesh Bhanga, Faridpur

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farhana Nargis, MBBS

CONTACT

01717512743; farhananargis2012@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)