Arsenical KeratosisNCT01735097
Effect of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
A study testing Vitamin E and Nigella sativa in people with Arsenical Keratosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arsenical Keratosis
- What is being tested?
- Vitamin E and Nigella sativa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2013to Nov 2013
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate palmer arsenical keratosis
- Patient drinking arsenic contaminated water (more than 0.05 mg/L) for more than six months
- Subjects those voluntarily agree to participate
Who cannot join
- Patient received treatment of arsenicosis for the last three months
- Pregnancy
- Lactating mother
- Eczema
- Psoriasis
- Contact dermatitis
Show all 9Show fewer
- Tuberculosis
- Diabetes mellitus
- Patients with hepatic and renal impairment
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Dhaka
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis
Read the detailed description
Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients
- Conditions
- Arsenical Keratosis
- Being tested
- Vitamin E, Nigella sativa, Placebo
- Keywords
- Arsenic, Keratosis, Nigella sativa, Palm, Vitamin E
- Medical subject headings
- Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDietary supplement
Vitamin E (200 mg, soft capsule)
Nigella sativaDietary supplement
Nigella sativa (200 mg, soft capsule)
PlaceboDietary supplement
Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
| Study group | Role | What they receive |
|---|---|---|
| Arsenical keratosis (Study) | Experimental | Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks Receives: Dietary Supplement: Vitamin E; Dietary Supplement: Nigella sativa |
| Arsenical keratosis (Control) | Active comparator | Vitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks Receives: Dietary Supplement: Vitamin E; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of signs and symptoms of palmer arsenical keratosis
Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor.
Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.
Measured: up to 12 weeks
Secondary outcomes (5)
Arsenic level in nails
Amount of arsenic in nails will be estimated by Atomic Fluorescence spectrometry (AFS) both before and after completion of treatment.
Measured: 0 week (baseline), 12 weeks (end)
Estimation of serum vitamin E levels
To see any change in the concentration of plasma vitamin E levels after use of N.sativa capsules. This parameter will be estimated by spectrophotometric method.
Measured: 0 week (baseline), 12 weeks (end)
Estimation of serum total cholesterol levels
To see any change in the concentration of serum cholesterol levels after use of N. sativa. This parameter will be estimated by spectrophotometric method.
Measured: 0 week (baseline), 12 weeks (end)
Liver function
To see any change in the concentration of serum bilirubin, transaminase levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.
Measured: 0 week (baseline), 12 weeks (end)
Renal function
To see any change in the concentration of blood urea and serum creatinine levels after use of N. sativa. These parameters will be estimated by spectrophotometric method.
Measured: 0 week (baseline), 12 weeks (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arsenical KeratosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mir Misbahuddin, MBBS, PhD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735097
- Sponsor's protocol ID
- BSMMU-002-CT
- Status last verified
- May 2014
- First submitted
- 15 Nov 2012
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
- ClinicalTrials.gov ID
- NCT01735097
- Acronym / sponsor ID
- BSMMU-002-CT
- Conditions
- Arsenical Keratosis
- Keywords
- Arsenic, Keratosis, Nigella sativa, Palm, Vitamin E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Nov 2012 (estimated)
- 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.
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis
Detailed description
Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arsenical keratosis (Study) | Experimental | Dietary Supplement: Vitamin E, Dietary Supplement: Nigella sativaVitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks |
| Arsenical keratosis (Control) | Active comparator | Dietary Supplement: Vitamin E, Dietary Supplement: PlaceboVitamin E (200 mg, soft capsule) plus Placebo (refined oil in soft capsule with same size and color as that contains N sativa) twice daily, orally for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Moderate palmer arsenical keratosis
- Patient drinking arsenic contaminated water (more than 0.05 mg/L) for more than six months
- Subjects those voluntarily agree to participate
Key exclusion criteria (9 listed)
- Patient received treatment of arsenicosis for the last three months
- Pregnancy
- Lactating mother
- Eczema
- Psoriasis
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 |
|---|---|---|
| Vitamin EVitamin E (200 mg, soft capsule) | Dietary supplement | Arsenical keratosis (Control), Arsenical keratosis (Study) |
| Nigella sativaNigella sativa (200 mg, soft capsule) | Dietary supplement | Arsenical keratosis (Study) |
| PlaceboPlacebo (refined oil in soft capsule with same color and size like that contains N. sativa) | Dietary supplement | Arsenical keratosis (Control) |
Primary outcome
Clinical improvement of signs and symptoms of palmer arsenical keratosis
Time frame: up to 12 weeks
Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor. Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.
5 secondary outcomes
Arsenic level in nails
Time frame: 0 week (baseline), 12 weeks (end)
Estimation of serum vitamin E levels
Time frame: 0 week (baseline), 12 weeks (end)
Estimation of serum total cholesterol levels
Time frame: 0 week (baseline), 12 weeks (end)
Liver function
Time frame: 0 week (baseline), 12 weeks (end)
Renal function
Time frame: 0 week (baseline), 12 weeks (end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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.
Mir Misbahuddin, MBBS, PhD 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 Vitamin E and Nigella sativa in people with Arsenical Keratosis, 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 5 May 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement of signs and symptoms of palmer arsenical keratosis (time frame: up to 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 5 May 2014.