Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis

This study has been completed.
Sponsor:
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: May 2, 2014
Last verified: May 2014
  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:


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.


Enrollment: 50
Study Start Date: January 2013
Study Completion Date: March 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731756

Locations
Bangladesh
Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
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: May 2, 2014
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
Skin Diseases
Precancerous Conditions
Neoplasms
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
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014