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NCT03639831
ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
NA trial testing Proprietary, standardized botanical extract in Mood Disorders in 65 participants. Completed in 31 March 2019.
15 November 2018
Quick facts
| Lead sponsor | Activ'inside |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 65 |
| Start date | 6 November 2017 |
| Primary completion | 15 November 2018 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Proprietary, standardized botanical extract
- Placebo (maltodextrin)
Conditions studied
- Mood Disorders — all drugs for Mood Disorders →
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):
-
Depression and Its Phytopharmacotherapy-A Narrative Review.
Dobrek L, Głowacka K. · · 2023 · cited 72× · PMID 36902200 · DOI 10.3390/ijms24054772 -
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:
- PubMed search for NCT03639831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06412315 — 7T Amygdala and Citalopram Study · NA · recruiting
Other Activ'inside trials
Trials by the same sponsor.
- NCT07013539 — Efficacy of a Food Supplement in Relieving Premenstrual Syndrome Symptoms · NA · active not recruiting
- NCT06545552 — Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium · NA · completed
- NCT05098093 — Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults · NA · completed
- NCT04697589 — Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects · NA · completed
- NCT04523870 — Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03639831 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Activ'inside
- Last refreshed: 10 April 2019
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