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NCT03639831

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

Completed NA Last updated 10 April 2019
What this trial tests

NA trial testing Proprietary, standardized botanical extract in Mood Disorders in 65 participants. Completed in 31 March 2019.

Timeline
6 November 2017
Primary endpoint
15 November 2018
31 March 2019

Quick facts

Lead sponsorActiv'inside
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment65
Start date6 November 2017
Primary completion15 November 2018
Estimated completion31 March 2019
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Activ'inside

Who can join

Adults 18 to 60, any sex, with Mood Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide. In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials. However, only few studies looked at the effects of these botanicals on mood in healthy subjects. The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Depression and Its Phytopharmacotherapy-A Narrative Review.
    Dobrek L, Głowacka K. · · 2023 · cited 72× · PMID 36902200 · DOI 10.3390/ijms24054772
  2. Effects of Saffron Extract Supplementation on Mood, Well-Being, and Response to a Psychosocial Stressor in Healthy Adults: A Randomized, Double-Blind, Parallel Group, Clinical Trial.
    Jackson PA, Forster J, Khan J, Pouchieu C, et al · · 2020 · cited 37× · PMID 33598475 · DOI 10.3389/fnut.2020.606124

Verify or expand the search:

Other recruiting trials for Mood Disorders

Currently open trials in the same condition.

Other Activ'inside trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03639831.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing