A study to evaluate the efficacy of Eclipta prostrata (L.) L. in the treatment of atopic dermatitis in children

A double-blind, randomized, placebo-controlled study to evaluate the efficacy of Eclipta prostrata (L.) L. in the treatment of atopic dermatitis in children above 2 years old

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2fqcbrx

Enrollment

Unknown

Registered

2022-12-16

Start date

2023-01-09

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatits

Interventions

Initially, patients will be evaluated clinically, through SCORAD, frequency of use of topical medications and laboratorially, through the prick test and inflammation and immunological tolerance throug

B01.875.800.575.912.250.100.337

Eligibility

Age

2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children and adolescents between 2 and 18 years old; clinical diagnosis of atopic dermatitis, according to the Hanifin and Rajka criteria

Exclusion criteria

Exclusion criteria: Diagnosis or presence of acute or chronic cutaneous diseases, not suggestive of atopic dermatitis, that may interfere with the study results; use of corticosteroids, systemic immunosuppressants or immunobiologicals for at least 30 days before or during participation in the study; allergy or serious adverse events attributable to the administration of the investigational product; non-adherence to treatment (ie, not using the investigational product regularly, as prescribed) for at least one continuous month; failure to attend more than 50% of the evaluations (clinical and/or laboratory) that will be carried out during the study

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical efficacy of Eclipta prostrata in the manifestations of atopic dermatitis in children and adolescents, using the SCORAD (scoring atopic dermatitis).	—

Secondary

Measure	Time frame
To assess the effects of Eclipta prostrata on the need for topical corticosteroids and immunosuppressants. ;To evaluate the effects of Eclipta prostrata on the quality of life of patients with atopic dermatitis, using the Children's Dermatology Life Quality (CDLQI) score.;Evaluate the effects of Eclipta prostrata on the following laboratory parameters: prick test, total serum IgE, serum concentrations of IFN-?, IL-1ß, IL-4, IL-5, IL-6, IL-13, IL-17, TNF-a, IL-10 and TGF-ß.;Evaluate possible adverse events related to Eclipta prostrata.	—

Measure

Time frame

To assess the effects of Eclipta prostrata on the need for topical corticosteroids and immunosuppressants. ;To evaluate the effects of Eclipta prostrata on the quality of life of patients with atopic dermatitis, using the Children's Dermatology Life Quality (CDLQI) score.;Evaluate the effects of Eclipta prostrata on the following laboratory parameters: prick test, total serum IgE, serum concentrations of IFN-?, IL-1ß, IL-4, IL-5, IL-6, IL-13, IL-17, TNF-a, IL-10 and TGF-ß.;Evaluate possible adverse events related to Eclipta prostrata.

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Countries

Brazil

Contacts

Public ContactSoraya Abu Jamra

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - USP

sorayajamra@yahoo.com.br+551636022029

Outcome results

None listed

Source: REBEC (via WHO ICTRP)