Keratotic Nodular SizeNCT04686461
Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis
A study testing Nigella sativa seeds extract containing ointment intervention in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Keratotic Nodular Size
- What is being tested?
- Nigella sativa seeds extract containing ointment intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 Oct 2019to 20 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Bhanga
Farīdpur
Farhana Nargis, MBBS, 01717512743, farhananargis2012@gmail.com
About this study
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.
Read the 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.
- Conditions
- Keratotic Nodular Size
- Being tested
- Nigella sativa seeds extract containing ointment intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativa seeds extract containing ointment interventionDrug
Nigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol
| Study group | Role | What they receive |
|---|---|---|
| Nigella sativa seeds extract containing ointment intervention | Experimental | Nigella sativa seeds extract containing ointment dose- twice daily for 12 weeks Receives: Drug: Nigella sativa seeds extract containing ointment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratotic nodular size
Lesion size will be measured by slide calipers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start20 Oct 2019
- Primary completion20 Jan 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratotic Nodular SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Farhana Nargis, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Bangladesh Bhanga, Faridpur, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686461
- Sponsor's protocol ID
- BSMMU/2020/1642
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis
- ClinicalTrials.gov ID
- NCT04686461
- Acronym / sponsor ID
- BSMMU/2020/1642
- Conditions
- Keratotic Nodular Size
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nigella sativa seeds extract containing ointment intervention | Experimental | Drug: Nigella sativa seeds extract containing ointment interventionNigella sativa seeds extract containing ointment dose- twice daily for 12 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella sativa seeds extract containing ointment interventionNigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol | Drug | Nigella sativa seeds extract containing ointment intervention |
Primary outcome
Keratotic nodular size
Time frame: 12 weeks
Lesion size will be measured by slide calipers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bangladesh Bhanga, Faridpur principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella sativa seeds extract containing ointment intervention in people with Keratotic Nodular Size, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farhana Nargis, MBBS (01717512743, farhananargis2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratotic nodular size (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.