CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 75 enrolled
Drug / intervention
Stabilised Whole Rice Brandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04635072
NCT04635072Early Ph 1Completed

Is 100% Pure Stabilized Whole Rice Bran (SWRB) Effective When Used as a Cleanser and an Emollient in Patients With Mild to Moderate Atopic Dermatitis?

RCSI & UCD Malaysia Campus·interventional·Posted Nov 18, 2020·Updated Mar 29, 2023

In Brief

A Early Phase 1 clinical trial evaluating Stabilised Whole Rice Bran for Dermatitis, Atopic. Completed, enrolled 75 participants across 1 site.

Detailed Summary

This clinical trial serves to look at the effectiveness of SWRB for the treatment of mild to moderate Atopic Dermatitis in patients below the age of 18. Atopic Dermatitis (AD) is a common condition seen in dermatology, paediatric and primary care clinics in Malaysia. AD poses a significant biopsychosocial burden among sufferers and their families. Current management patterns of AD sufferers in South-east Asia mainly involve use of topical moisturizers and topical corticosteroids. Rice bran and products derived from it have been studied regarding their anti-oxidant, nutritional, cholesterol lowering and health promoting properties. However, there are very few studies that have focused on the benefits of SWRB when used topically. SWRB is cost-effective and easily available, while being an under-utilised product. The investigators wanted to study its effectiveness in controlling the signs and symptoms of Atopic Dermatitis when used as a cleanser and topical paste (emollient) as very little is known on this subject. The investigators wish to study participants below 18 years of age with mild and moderate Atopic Dermatitis. The participants will be followed up for four to six (4 - 6) weeks and the clinical features tabulated. This study does not involve any enteral or parenteral administration of SWRB. Neither does it involve any invasive procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedNov 18, 2020
Enrollment StartSep 21, 2020
Primary CompletionApr 20, 2021
Study CompletionSep 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

Stabilised Whole Rice Brandrug

Patients with mild Atopic Dermatitis (AD) will be given SWRB in powder form, to be used as a cleanser after adding water to it according to set proportions given as instructions, once a day. Patients with moderate disease will use SWRB as a cleanser. In addition, they will also use SWRB as an emollient.