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

January 7, 2021 updated by: Dr. Farhana Nargis, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arsenicosis is a massive public health problem affecting thousands of people worldwide, especially India, West Bengal, and Bangladesh. In our country groundwater of estimated 59 administrative districts have been contaminated with high concentration of arsenic. Through this contaminated drinking water a large number of populations are chronically exposed to high concentration of arsenic. Arsenicosis is characterized by diffuse melanosis followed by hyperpigmentation and keratosis. Keratosis causes reduce working capacity that affects socioeconomic condition of the patient. Invasive skin lesions like squamous cell carcinoma, Bowen's disease, and basal cell carcinoma also caused by it. Keratosis can treated by several topical preparation like propylene glycol, salicylic acid, alpha-lipoic acid, neem leaf extract, solanum melongena extract, Azadirachta indica and oral preparation like zinc, antioxidant, and folic acid. This treatment procedure required longer time to relieve symptom and reduce patient's compliance. Nigella sativa is a well-known spice of Southeast Asia, especially in Bangladesh. It contains a yellow volatile oil, a fixed oil, protein, amino acid, reducing sugars, alkaloids, and minerals like potassium, sodium, phosphorus, and iron while zinc, magnesium, calcium, copper, and manganese are found in low level. Thymoquinone is a main pharmacologically active constituent of volatile oil of N. sativa. Other constituents of the volatile oil are thymol, thymohydroquinone, and dithymoquinone. These biologically active compounds possess antimicrobial, anti-inflammatory, antioxidant, immunological, antimetastatic, anti-diabetic activity. Study with Nigella sativa in the treatment of arsenical keratosis was done and found effective. Therefore, the study will be done to identification of compound that is isolated from Nigella sativa and its effect on moderate to severe arsenical keratosis. . After obtaining clearance from IRB, on the basis of selection criteria, 34 patients of arsenical keratosis will be enlisted from Bhanga Upazilla of Faridpur district, an arsenic affected area. The study will be an experimental study and conducted in Bangabandhu Sheikh Mujib Medical University. Nigella sativa extract will be collected by using n-hexane as a solvent and rotary evaporator. Thin Layer Chromatography (TLC), Nuclear Magnetic Resonance (NMR) and Infrared (IR) spectrometry of the extract will be done to identify compound. Cytotoxicity test of the extract will be analyzed by using brine shrimp bioassay. . Then a topical ointment will be prepared from Nigella sativa extract and supplied to the arsenical keratosis patient at two weeks interval. Instruction about the application of the ointment on keratotic lesion will be given to the patients. Adherence and side effects of the ointment will be monitored at regular interval over phone calls and during field visit. Keratotic nodular size will be measured before start and after completion of treatment. Photograph will also take before and after treatment. Improvement of the lesion will be measured by mean scoring of nodule and perception of patients about their improvement by using Likert Scale. Statistical analysis and results will be presented in tabulated forms and in different diagrams.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nigella sativa seeds extract containing ointment intervention
Nigella sativa seeds extract containing ointment dose- twice daily for 12 weeks
Drug: Nigella sativa seeds extract containing ointment intervention
Nigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Keratotic nodular size
Time Frame: 12 weeks
Lesion size will be measured by slide calipers
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bangladesh Bhanga, Faridpur, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BSMMU/2020/1642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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