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

Sponsor

Comercial Quimica Masso, S.A (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06138470

Collaborator

Université Catholique de Louvain (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.

Condition or Disease	Intervention/Treatment	Phase
Mood Regulation	Dietary Supplement: Saffron extract Dietary Supplement: Scutellaria baicalensis extract Dietary Supplement: Saffron and Scutellaria baicalensis extract Dietary Supplement: Placebo (maltodextrin)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Evaluation of the Effect of a Combination of Plants (Saffron and Scutellaria) to Regulate Mood

Actual Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Saffron extract	Dietary Supplement: Saffron extract Food supplements are taken during 6 weeks by healthy volunteers
Active Comparator: Scutellaria baicalensis extract	Dietary Supplement: Scutellaria baicalensis extract Food supplements are taken during 6 weeks by healthy volunteers
Active Comparator: Saffron and Scutellaria baicalensis extract	Dietary Supplement: Saffron and Scutellaria baicalensis extract Food supplements are taken during 6 weeks by healthy volunteers
Placebo Comparator: Placebo (maltodextrin)	Dietary Supplement: Placebo (maltodextrin) Food supplements are taken during 6 weeks by healthy volunteers

Outcome Measures

Primary Outcome Measures

Evaluated mood regulation [Baseline and 6 weeks]
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.

Secondary Outcome Measures

Evaluated mood regulation [3 and 6 weeks of intervention and after 2 weeks after the end of intervention]
Beck Inventory Depression (BDI) score. All items are scored on a 4-point scale, ranging from 0 to 3.
Evaluated mood regulation [after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention]
Hamilton depression rating scale (HAMD) score. HAMD is composed of 21 items. The scoring is based on the first 17 items. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Woman or man, aged of 18 to 75 years;
Participant presenting a depressive episode, according to the DSM-5 definition;
Participant presenting a BDI ≥ 14 and ≤ 28 at the inclusion, corresponding to mild to moderate symptoms;
Participant with a recent episode of depression (less than 2 years), not managed by antidepressant or psychotherapeutic treatment;
Participant with a current depressive disorder not requiring, in the investigator's opinion, the initiation of antidepressant medication;
Provision of signed and dated informed consent form;
Stated willingness to comply with all study procedures and availability for the duration of the study;
French speaker.

Exclusion Criteria:

Participant with a depressive disorder of another nature or any other mental pathology (schizophrenia, bipolarity, addiction to alcohol or drugs...);
Participant at risk of suicide (determined by the Investigator, or HAMD item 3 score >

or having made a suicide attempt in the last 5 years;

Participant with depression for more than 2 years;
Participant undergoing psychotropic treatment (current or in the month prior to inclusion) (neuroleptic, anxiolytic, hypnotic);
Participant with a serious health problem for which the Investigator considers that it is not in the participant's interest to participate in the study;
Participant using products containing piperine or millpertuis, or having a known effect on mood within the last 4 weeks;
Pregnant or breastfeeding women, or those planning to become pregnant within the next 8 weeks;
Participant with an allergy or contraindication to any component of the study drug;
Participant unable to understand study information (mental or linguistic disability);
Participant who is participating or has participated in the previous month in another clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université Catholique de Louvain, CICN	Ottignies-Louvain-la-Neuve		Belgium	1348

Sponsors and Collaborators

Comercial Quimica Masso, S.A
Université Catholique de Louvain

Investigators

Study Chair: Valérie Dormal, PhD, Université Catholique de Louvain
Study Director: Louise Deldicque, Pr, Université Catholique de Louvain
Principal Investigator: Laurent Simar, Dr, Université Catholique de Louvain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Comercial Quimica Masso, S.A

ClinicalTrials.gov Identifier:

NCT06138470

Other Study ID Numbers:

SAFFRUP

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2023