NCT03147053

Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression

Completed EARLY_PHASE1 Last updated 21 August 2019

What this trial tests

EARLY_PHASE1 trial testing Jiedu Tongluo granules in Post-stroke Depression in 55 participants. Completed in 24 January 2018.

Timeline

27 April 2017

Primary endpoint
7 July 2017

24 January 2018

Quick facts

Lead sponsor	Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	27 April 2017
Primary completion	7 July 2017
Estimated completion	24 January 2018
Sites	1 location across China

Drugs / interventions tested

• Jiedu Tongluo granules — full drug profile →
• Placebo

Conditions studied

• Post-stroke Depression — all drugs for Post-stroke Depression →

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 45 to 80, any sex, with Post-stroke Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group was administered the Jiedu Tongluo granules, while the control group was administered the placebo.

Publications & conference data

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

1. The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial.
   Zhao AM, Qiu WR, Mao LJ, Ren JG, et al · · 2018 · cited 5× · PMID 29747670 · DOI 10.1186/s13063-018-2633-4