Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis

NCT ID: NCT04693000

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-23
• Study Completion Date: 2021-01-15

Brief Summary

Arsenic is one of the largest mass poisonings in Bangladesh. Arsenic keratosis of the palm and sole is a common feature of arsenicosis. Brinjal or eggplant ubiquitous vegetable found in different parts of the world, including Bangladesh, scientifically known as Solanum melongena. A study showed ointment containing crude extract of Solanum melongena peel origin is effective in arsenic keratosis. Solasodine is one of the active compounds of Solanum melongena peel. In the current study, an ointment containing a single compound solasodine isolated from Solanum melongena peel . The ointment made from solasodine extract was distributed among arsenic keratosis patients to see the effect.

Detailed Description

About millions of Bangladeshi people are chronically exposed to high arsenic concentrations (above 50 micrograms/liter) through contaminated drinking water and thus suffer from arsenic-related health hazards called arsenicosis. Arsenic keratosis is one of the commonest skin manifestations of arsenicosis that occur in the palm and sole that is troublesome for the working people and females suffered a negative socio-economic impact.

Two studies were conducted in the same department where topical ointment prepared from the crude extract of S. melongena peel was found effective in arsenical keratosis.

The present study was conducted to confirm the previous study and identify that solasodine isolated from S. melongena peel is responsible for the cure of the lesions of arsenical keratosis. Thus, it may be possible for the chemical synthesis of solasodine, and an effective, inexpensive topical ointment can be prepared for the cure of arsenical keratosis.

Conditions

Keratotic Nodular Size

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.

Keratotic nodular size observation after 12 weeks

Group Type: EXPERIMENTAL

Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

Intervention Type: DRUG

An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.Keratotic nodular size observation after 12 weeks

Interventions

Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.Keratotic nodular size observation after 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Presence of moderate to severe palmar arsenical keratosis
• Drinking arsenic-contaminated water for at least six months
• Patient voluntarily agreed to participate

Exclusion Criteria

• Age less than 18 years or more than 60 years
• Pregnant and nursing mother
• Skin diseases like atopic dermatitis eczema and psoriasis
• Patient allergic to brinjal (eggplant)
• Patient taken any treatment of arsenicosis for the last six months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr Mohammad Sazzad Hossain

MBBS, MD(Phase B) Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Muradnagar Upazilla

Comilla, , Bangladesh

Countries

Bangladesh

Other Identifiers

BSMMU/2019/10655

Identifier Type: -

Identifier Source: org_study_id