AsdamarinTM relieves functional dyspepsia in healthy adults in only 7 days: A randomized, double-blind, placebo-controlled pilot study

Abstract

Functional dyspepsia (FD) is a prevalent global health concern increasing with years. Inspired by the Traditional Chinese Medicine (TCM) liver-stomach disharmony syndrome in order to find a quick natural alternative treatment, a Ferula asafoetida-Silybum marianum (Asdamarin™) combined extract has been developed and proved its rapid efficiency and its safety with a 7-day randomized, double-blind, placebo-controlled pilot study (CTRI/2018/05/013993 dated 21/05/2018) conducted on 70 healthy human volunteers (aged 18–60 years) supplemented with 250 mg / twice a day of either a placebo or Asdamarin™. Subjects were evaluated from baseline to the end of the study (EOS) through changes in Gastrointestinal Symptom Rating Scale (GSRS), changes in Glasgow Dyspepsia Severity Score (GDSS) and changes in the short form of Nepean Dyspepsia Index (NDI-SF) for Quality of Life. Compared to the baseline a significant reduction (p < 0.001) of GDSS questionnaire score was noted in the Asdamarin™ group (from 5.66 ± 3.1 at baseline to 5.09 ± 2.8 at the End Of Study (EOS)) compared to placebo group (from 2.77 ± 1.3 baseline to 2.69 ± 1.3 EOS), a significant decrease (p < 0.001) of GSRS score noted in the Asdamarin™ group (from 32.11 ± 8.6 baseline to 19.11 ± 5.4 EOS) compared to the placebo group (from 25.23 ± 3.6 baseline to 23.2 ± 4.9 EOS), and a significant reduction (p < 0.001) of NDI-SF scoring was noted in the Asdamarin™ group (from 15.74 ± 4.1 baseline to 11.54 ± 2.1 EOS) compared to placebo group (from 12.54 ± 3.2 baseline to 11.63 ± 2.6 EOS). Asdamarin™ has been found safe and very well tolerated during the study.