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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04686461
Other study ID # BSMMU/2020/1642
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2019
Est. completion date February 20, 2021

Study information

Verified date January 2021
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Farhana Nargis, MBBS
Phone 01717512743
Email farhananargis2012@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prepare an ointment from Nigella sativa seeds extract and apply it over palmer arsenical keratosis patient for 12 weeks. After than the effect of the ointment will be observed by measuring the keratotic nodular size before and after the intervention.


Description:

Arsenicosis is a massive public health problem affecting thousands of people worldwide, especially India, West Bengal, and Bangladesh. In our country groundwater of estimated 59 administrative districts have been contaminated with high concentration of arsenic. Through this contaminated drinking water a large number of populations are chronically exposed to high concentration of arsenic. Arsenicosis is characterized by diffuse melanosis followed by hyperpigmentation and keratosis. Keratosis causes reduce working capacity that affects socioeconomic condition of the patient. Invasive skin lesions like squamous cell carcinoma, Bowen's disease, and basal cell carcinoma also caused by it. Keratosis can treated by several topical preparation like propylene glycol, salicylic acid, alpha-lipoic acid, neem leaf extract, solanum melongena extract, Azadirachta indica and oral preparation like zinc, antioxidant, and folic acid. This treatment procedure required longer time to relieve symptom and reduce patient's compliance. Nigella sativa is a well-known spice of Southeast Asia, especially in Bangladesh. It contains a yellow volatile oil, a fixed oil, protein, amino acid, reducing sugars, alkaloids, and minerals like potassium, sodium, phosphorus, and iron while zinc, magnesium, calcium, copper, and manganese are found in low level. Thymoquinone is a main pharmacologically active constituent of volatile oil of N. sativa. Other constituents of the volatile oil are thymol, thymohydroquinone, and dithymoquinone. These biologically active compounds possess antimicrobial, anti-inflammatory, antioxidant, immunological, antimetastatic, anti-diabetic activity. Study with Nigella sativa in the treatment of arsenical keratosis was done and found effective. Therefore, the study will be done to identification of compound that is isolated from Nigella sativa and its effect on moderate to severe arsenical keratosis. . After obtaining clearance from IRB, on the basis of selection criteria, 34 patients of arsenical keratosis will be enlisted from Bhanga Upazilla of Faridpur district, an arsenic affected area. The study will be an experimental study and conducted in Bangabandhu Sheikh Mujib Medical University. Nigella sativa extract will be collected by using n-hexane as a solvent and rotary evaporator. Thin Layer Chromatography (TLC), Nuclear Magnetic Resonance (NMR) and Infrared (IR) spectrometry of the extract will be done to identify compound. Cytotoxicity test of the extract will be analyzed by using brine shrimp bioassay. . Then a topical ointment will be prepared from Nigella sativa extract and supplied to the arsenical keratosis patient at two weeks interval. Instruction about the application of the ointment on keratotic lesion will be given to the patients. Adherence and side effects of the ointment will be monitored at regular interval over phone calls and during field visit. Keratotic nodular size will be measured before start and after completion of treatment. Photograph will also take before and after treatment. Improvement of the lesion will be measured by mean scoring of nodule and perception of patients about their improvement by using Likert Scale. Statistical analysis and results will be presented in tabulated forms and in different diagrams.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date February 20, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - Age: 19 - 65 years - Arsenical keratosis: Presence of moderate to severe keratosis (>5 mm) in both palms or soles - Drinking arsenic-contaminated water (>50 µg/ L) for at least more than six months - Patient did not receive topical application of any drug for the last three months - Patient agreed to participate voluntarily - Patient who understood the instruction of applying drug and could apply drug as per an instruction Exclusion Criteria: - Age <19 and >65 years - Pregnant and nursing mother - Patient who received any treatment of arsenicosis within the last three months - Patient with skin diseases like atopic dermatitis, eczema, and psoriasis - Any systemic disease, inflammatory disease and infectious condition that affected the skin, for example, diabetes mellitus, rheumatoid arthritis, systemic lupus erythematosus and hepatitis - Food allergy to Nigella sativa

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nigella sativa seeds extract containing ointment intervention
Nigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol

Locations

Country Name City State
Bangladesh Bhanga Faridpur

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Keratotic nodular size Lesion size will be measured by slide calipers 12 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04693000 - Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis Phase 2
Recruiting NCT04608461 - Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis Phase 2
Recruiting NCT03641079 - Identification of Compound From Brinjal Peel Extract in the Treatment of Palmar Arsenical Keratosis and Bowen's Disease Phase 2
Recruiting NCT04686474 - Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis N/A
Recruiting NCT03632733 - Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis Phase 2