Chronic Arsenic PoisoningPhase 2NCT01748669
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
A Phase 2 study testing Garlic oil in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Arsenic Poisoning
- What is being tested?
- Garlic oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2011to Jul 2012
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- history of taking arsenic contaminated water (>50 ppb) for more than 6 months
- patients having mild to moderate arsenical keratosis present on palm of the hand
- patients those voluntarily agree to participate
- family member of the patient
- drinking arsenic contaminated water from the same source as patient
- those voluntarily agree to participate
Show all 9Show fewer
- no sign/symptom of palmer keratosis
- drinking arsenic safe water (<50 ppb)
- those voluntarily agree to participate
Who cannot join
- pregnancy
- lactating mother
- patient receiving treatment of arsenicosis
- any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
Trial locations and contacts
1 site in 1 country.
About this study
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.
Read the detailed description
Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.
- Conditions
- Chronic Arsenic Poisoning
- Being tested
- Garlic oil
- Keywords
- Arsenic, Arsenicosis, Garlic oil, Keratosis
- Medical subject headings
- Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic oilDietary supplement
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Patients of palmer arsenical keratosis | Experimental | One soft capsule of garlic oil (10 mg) daily for 12 weeks Receives: Dietary Supplement: Garlic oil |
| Arsenic exposed controls | Active comparator | One soft capsule of garlic oil (10 mg) daily for 12 weeks Receives: Dietary Supplement: Garlic oil |
| Heathy volunteers | Active comparator | One soft capsule of garlic oil (10 mg) daily for 12 weeks Receives: Dietary Supplement: Garlic oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical symptom of keratosis in palm
Measured: 0 week (baseline) to 12 weeks (end)
Secondary outcomes (3)
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
Measured: 0 week (baseline), 12 weeks (end)
Adverse effects following treament
Measured: 0 week (baseline), 12 weeks (end)
Change in the amount of arsenic in nail
Measured: 0 week (baseline), 20 weeks (end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Arsenic PoisoningStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748669
- Sponsor's protocol ID
- BSMMU-005-CT
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
- ClinicalTrials.gov ID
- NCT01748669
- Acronym / sponsor ID
- BSMMU-005-CT
- Conditions
- Chronic Arsenic Poisoning
- Keywords
- Arsenic, Arsenicosis, Garlic oil, Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Dec 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.
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.
Detailed description
Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients of palmer arsenical keratosis | Experimental | Dietary Supplement: Garlic oilOne soft capsule of garlic oil (10 mg) daily for 12 weeks |
| Arsenic exposed controls | Active comparator | Dietary Supplement: Garlic oilOne soft capsule of garlic oil (10 mg) daily for 12 weeks |
| Heathy volunteers | Active comparator | Dietary Supplement: Garlic oilOne soft capsule of garlic oil (10 mg) daily for 12 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- history of taking arsenic contaminated water (>50 ppb) for more than 6 months
- patients having mild to moderate arsenical keratosis present on palm of the hand
- patients those voluntarily agree to participate
- family member of the patient
- drinking arsenic contaminated water from the same source as patient
Key exclusion criteria (4 listed)
- pregnancy
- lactating mother
- patient receiving treatment of arsenicosis
- any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
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 |
|---|---|---|
| Garlic oilOral administration | Dietary supplement | Arsenic exposed controls, Heathy volunteers, Patients of palmer arsenical keratosis |
Primary outcome
Change in the clinical symptom of keratosis in palm
Time frame: 0 week (baseline) to 12 weeks (end)
3 secondary outcomes
Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment
Time frame: 0 week (baseline), 12 weeks (end)
Adverse effects following treament
Time frame: 0 week (baseline), 12 weeks (end)
Change in the amount of arsenic in nail
Time frame: 0 week (baseline), 20 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 12 Dec 2012.
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
Department of Pharmacology, 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 Phase 2 study testing Garlic oil in people with Chronic Arsenic Poisoning, 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 9 inclusion and 4 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 12 Dec 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the clinical symptom of keratosis in palm (time frame: 0 week (baseline) to 12 weeks (end)). 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 12 Dec 2012.