Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis (NCT04686461) | Clinical Trial Compass
UnknownNot Applicable
Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis
Bangladesh34 participantsStarted 2019-10-20
Plain-language 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.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Keratotic nodular size
Timeframe: 12 weeks
Trial details
NCT IDNCT04686461
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh