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

NCT05199545 | Completed

• 1 other identifier: PiL-Clin-ROSADE-021
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Psychological Well-being

Outcome Measures

Primary Outcomes (1)

• Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study

  Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome

  42 days

Secondary Outcomes (22)

• Evolution of depressive symptoms through HAM-D during the study

  42 days

• Evolution of depressive symptoms through HAM-D sub-scores during the study

  42 days

• Rate of responding participants (decrease of ≥ 3 points) at D21

  21 days

• Rate of responding participants (decrease of ≥ 3 points) at D42

  42 days

• Rate of responding participants (decrease of ≥ 5 points) at D21

  21 days

Study Arms (2)

Dietary supplement group

EXPERIMENTAL

2 tablets / day for 6 weeks of the dietary supplement (Rhodiola rosea L. and Crocus sativus L.), to be taken every day in the morning with a large glass of water, from D1 to D42.

Dietary Supplement: Dietary supplement

Placebo group

PLACEBO COMPARATOR

2 tablets / day for 6 weeks of the placebo, to be taken every day in the morning with a large glass of water, from D1 to D42.

Other: Placebo

Interventions

Dietary supplement DIETARY_SUPPLEMENT

Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts

Dietary supplement group

Placebo OTHER

Placebo of the dietary supplement

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years old ;
• Patient with a moderate depressive episode (F32.1 by ICD10 definition) ;
• Recent depression (less than 6 months), not managed by antidepressant or psychotherapeutic treatment ;
• Depressive disorder not requiring, in the opinion of the investigator, initiation of antidepressant drug therapy ;
• Patient able to understand the study information, read the information leaflet, and willing to sign the consent form ;
• French speaking patient.

You may not qualify if:

• Patient with a depressive disorder of another nature or any other mental illness (schizophrenia, bipolarity, alcohol or drug addiction, etc.);
• Patient at risk of suicide (noted by the investigator, or HAM-D item 3 score \> 2) or having attempted suicide in the last 5 years;
• Depression felt for more than 6 months ;
• Patient on beta-blocker therapy ;
• Patient on dialysis ;
• Patient using products containing piperine or St. John's wort, or having a known effect on mood in the last 30 days ;
• Woman who is pregnant or breastfeeding, or has plans to become pregnant in the next 8 weeks ;
• Patient with an allergy or contraindication to one of the components of the product under study (rhodiola or saffron) ;
• Patient unable to understand information related to the study (mental or linguistic disability) ;
• Patient participating or having participated in the previous 3 months in another clinical trial ;

Sponsors & Collaborators

• Larena SAS: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

CICN - Université Catholique de Louvain

Louvain-la-Neuve, Belgium

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: April 26, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)