NCT01735097

Brief Summary

Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

November 15, 2012

Last Update Submit

May 2, 2014

Conditions

Arsenical Keratosis

Keywords

ArsenicKeratosisNigella sativaPalmVitamin E

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 12 weeks

Secondary Outcomes (5)

  • Arsenic level in nails

    0 week (baseline), 12 weeks (end)

  • Estimation of serum vitamin E levels

    0 week (baseline), 12 weeks (end)

  • Estimation of serum total cholesterol levels

    0 week (baseline), 12 weeks (end)

  • Liver function

    0 week (baseline), 12 weeks (end)

  • Renal function

    0 week (baseline), 12 weeks (end)

Study Arms (2)

Arsenical keratosis (Study)

EXPERIMENTAL

Vitamin E (200 mg, soft capsule) plus Nigella sativa (500 mg, soft capsule) twice daily, orally for 12 weeks

Dietary Supplement: Vitamin EDietary 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

Dietary Supplement: Vitamin EDietary Supplement: Placebo

Interventions

Vitamin EDIETARY_SUPPLEMENT

Vitamin E (200 mg, soft capsule)

Arsenical keratosis (Control)Arsenical keratosis (Study)
Nigella sativaDIETARY_SUPPLEMENT

Nigella sativa (200 mg, soft capsule)

Arsenical keratosis (Study)
PlaceboDIETARY_SUPPLEMENT

Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)

Arsenical keratosis (Control)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient received treatment of arsenicosis for the last three months
  • Pregnancy
  • Lactating mother
  • Eczema
  • Psoriasis
  • Contact dermatitis
  • Tuberculosis
  • Diabetes mellitus
  • Patients with hepatic and renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Keratosis

Interventions

Vitamin ENigella sativa oil

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mir Misbahuddin, MBBS, PhD

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. and Chairman, Department of Pharmacology

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 28, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

BA(1)