Trials Sponsors Conditions Drugs Pricing

Conditions

Mood Regulation

Outcome Measures

Primary Outcomes (1)

Evaluated mood regulation
observe a difference of the Beck Inventory Depression (BDI) score (adjusted for baseline), after 6 weeks of supplementation. All items are scored on a 4-point scale, ranging from 0 to 3.
Baseline and 6 weeks

Secondary Outcomes (2)

Evaluated mood regulation
3 and 6 weeks of intervention and after 2 weeks after the end of intervention
Evaluated mood regulation
after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention

Study Arms (4)

Saffron extract

ACTIVE COMPARATOR

Dietary Supplement: Saffron extract

Scutellaria baicalensis extract

ACTIVE COMPARATOR

Dietary Supplement: Scutellaria baicalensis extract

Saffron and Scutellaria baicalensis extract

ACTIVE COMPARATOR

Dietary Supplement: Saffron and Scutellaria baicalensis extract

Placebo (maltodextrin)

Interventions

Saffron extractDietary supplement

Food supplements are taken during 6 weeks by healthy volunteers

Saffron extract

Scutellaria baicalensis extractDietary supplement

Food supplements are taken during 6 weeks by healthy volunteers

Scutellaria baicalensis extract

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Woman or man, aged of 18 to 75 years;
Participant presenting a depressive episode, according to the DSM-5 definition;

Sponsors & Collaborators

Comercial Quimica Masso, S.A
Industrylead
Université Catholique de Louvain
Othercollaborator

Study Sites (1)

Université Catholique de Louvain, CICN

Ottignies-Louvain-la-Neuve, 1348, Belgium

MeSH Terms

Interventions

Scutellaria baicalensis extractmaltodextrin

Study Officials

Valérie Dormal, PhD
Université Catholique de Louvain
STUDY CHAIR
Louise Deldicque, Pr
Université Catholique de Louvain
STUDY DIRECTOR
Laurent Simar, Dr
Université Catholique de Louvain
PRINCIPAL INVESTIGATOR

Enrollment

180 participants (actual enrollment reported by the registry).

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

November 14, 2023

First Posted

November 18, 2023

Study Start

May 30, 2022

Actual (reported)

Evaluation of the Effect of a Combination of Plants to Regulate Mood

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Saffron extract

Scutellaria baicalensis extract

Saffron and Scutellaria baicalensis extract

Placebo (maltodextrin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Saffron extract

Scutellaria baicalensis extract

Saffron and Scutellaria baicalensis extract

Placebo (maltodextrin)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations