NCT05199545

Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Larena SAS · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the effect of a 6-week supplementation with a dietary supplement based on plant extracts to the effect of placebo, in patients with a moderate depressive episode (F32.1 by ICD10 definition) and with moderate symptoms (score HAM-D ≥ 16 and ≤ 23).

Detailed description

Longitudinal, comparative, randomized, placebo-controlled interventional study in 2 parallel groups, double-blind, monocentre, aimed at demonstrating the superiority of the combination of plants over placebo on depressive symptoms. Each patient will be followed for a maximum of 6 weeks, with 3 visits to the doctor.

Conditions

• Psychological Well-being

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary supplement	Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts
OTHER	Placebo	Placebo of the dietary supplement

Timeline

• Start date: 2022-04-26
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2022-01-20
• Last updated: 2025-07-15

Locations

1 site across 1 country: Belgium