Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis
This study is currently recruiting participants.
Verified April 2013 by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Information provided by (Responsible Party):
Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:
NCT01731756
First received: November 16, 2012
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial
| Condition | Intervention |
|---|---|
|
Arsenical Keratosis |
Other: Leaf extract of A. indica Drug: Salicylic Acid (6%) Other: Petroleum jelly |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
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MedlinePlus related topics:
Arsenic
U.S. FDA Resources
Further study details as provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Primary Outcome Measures:
- Changes in palmer arsenical keratosis [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]Size and number of keratotic lesions will be reduced. These will be expressed in score.
Secondary Outcome Measures:
- Changes in arsenic level in nail [ Time Frame: 0 week (baseline), 12 weeks (end) ] [ Designated as safety issue: No ]Arsenic level in nail of the patient will be decrease. Total arsenic level will be estimated by atomic fluorescence spectrometer.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Palmer arsenical keratosis (study)
Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
|
Other: Leaf extract of A. indica
Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
Drug: Salicylic Acid (6%)
Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
Other: Petroleum jelly
Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
|
|
Placebo Comparator: Palmer arsenical keratosis (control)
Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks
|
Drug: Salicylic Acid (6%)
Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
Other: Petroleum jelly
Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
|
Detailed Description:
The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Palmer arsenical keratosis
- Drinking arsenic contaminated water (>50 ppb) for more than six months
- Patient voluntarily agree to participate
Exclusion Criteria:
- Pregnancy
- Lactating mother
- Diabetes mellitus
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Psoriasis
- Bowen's disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731756
Contacts
| Contact: Mir Misbahuddin, MBBS, PhD | 8801849396067 | misbah@bdjpharmacol.com |
| Contact: Jannatus Ferdous, MBBS | 8801816322397 | jannat_fkh@yahoo.com |
Locations
| Bangladesh | |
| Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University | Recruiting |
| Dhaka, Bangladesh | |
| Contact: Mir Misbahuddin, MBBS, PhD 8801849396067 misbah@bdjpharmacol.com | |
| Contact: Jannatul Ferdous, MBBS 8801816322397 jannat_fkh@yahoo.com | |
| Principal Investigator: Mir Misbahuddin, MBBS, PhD | |
| Sub-Investigator: Jannatul Ferdous, MBBS | |
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
| Principal Investigator: | Mir Misbahuddin, MBBS, PhD | BSMMU |
More Information
No publications provided
| Responsible Party: | Prof. Mir Misbahuddin, Prof. and Chairman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT01731756 History of Changes |
| Other Study ID Numbers: | BSMMU-003-CT |
| Study First Received: | November 16, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | Bangladesh: Ethical Review Committee |
Keywords provided by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
|
Palm Arsenic Keratosis |
Salicylic acid Azadirachta indica Neem |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Ichthyosis Keratoacanthoma Skin Diseases Precancerous Conditions Neoplasms Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases Petrolatum Salicylic Acid Salicylates Emollients Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Anti-Infective Agents Antifungal Agents Keratolytic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013