NCT03935061

Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder

Status unknown NA Last updated 11 September 2019

What this trial tests

NA trial testing Mulberry juice in General Anxiety Disorders in 104 participants. Status unknown.

Timeline

3 July 2019

Primary endpoint
30 June 2020

31 May 2021

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	104
Start date	3 July 2019
Primary completion	30 June 2020
Estimated completion	31 May 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Mulberry juice

Conditions studied

• General Anxiety Disorders — all drugs for General Anxiety Disorders →
• Systemic Inflammation — all drugs for Systemic Inflammation →
• Interleukin — all drugs for Interleukin →

Sponsor

Taipei Medical University

Who can join

Adults 20 to 65, any sex, with General Anxiety Disorders or Systemic Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anxiety and depression are normally associated with inflammation reactions and interleukin (IL) related pathways are most evidently involved. IL-17A (interleukin 17A) induces psoriasis-like inflammation and depression-like behaviors in animals and can be relieved by using IL-17A antibody. Also, human association studies found that IL-17A and certain downstream ILs are associated with the severity of anxiety. IL-17A is a sentinel cytokine. On binding with interleukin 17A receptor (IL-17RA) and interleukin 17C receptor (IL-27RC), it induces signaling cascades via nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB), P38 mitogen-activated protein kinases (p38MAPK) and CCAAT-enhancer-binding proteins (C/EBPs) knots, and stimulates subsequent cell secretions of cytokines and chemokines. Cyanidin 3-O-glucoside, the main anthocyanin component of mulberry, competes with IL-17A to bind its receptors and inhibits subsequent downstream cascades. The investigators plan to use a single-blinded randomized controlled trial to evaluate the auxiliary effect of mulberry juice in general anxiety disorder, including differences in psychiatric symptoms and levels of IL-related markers between the experimental and control groups, and contribution of IL-related genes in the auxiliary effect.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418