Modified GuiGanLongMu Decoction for Preventing Delirium in Elderly

Status Not yet recruiting

Clinical Trial Summary

Elderly critically ill patients in the intensive care unit (ICU) are at risk of delirium, which is primarily characterized by acute consciousness impairment and perceptual, cognitive, and memory impairment, resulting in excess death, care expenditures, and acquired dementia, depression and anxiety, which severely affect the prognosis of critically ill patients. However, there are currently no effective pharmacological strategies for preventing delirium. Traditional Chinese Medicine (TCM) has extensive clinical experience in treating cognitive disorders. Therefore, we hypothesized that the use of GuiGanLongMu (GGLM) decoction, which is a classic prescription formula in traditional Chinese medicine, would reduce the incidence rate, shorten the duration and reduce the severity of delirium in ICU patients.

Clinical Trial Description

This revised GGLM decoction trial was designed to be a randomized, single-center, double-blind, placebo-controlled trial. A total of 208 elderly patients from two ICUs will be randomly allocated at a 1:1 ratio to the intervention group or the control group. Both groups will receive the ABCDEF (A2F) bundle strategy recommended by guidelines, a nonpharmacological multicomponent approach including pain and delirium management, breathing trial practice, analgesic and sedation usage control, family engagement and so on, to prevent delirium. The intervention group will additionally receive revised GGLM decoction twice a day for five days, followed by a 3-month follow-up. The control group will be received placebo made of flavoring agents. The primary endpoints are the incidence, severity, and duration of delirium. Secondary endpoints include the incidence of adverse events, the length of ICU stay, the duration of physical restraint, the duration of analgesic and sedative medication, the 28-day mortality rate, and the level of anxiety and depression in patients after discharge. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06100029
Study type	Interventional
Source	Chongqing Traditional Chinese Medicine Hospital
Contact
Status	Not yet recruiting
Phase	N/A
Start date	November 1, 2023
Completion date	November 30, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Modified GuiGanLongMu Decoction for Preventing Delirium in Elderly Intensive Care Unit Patients: Study Protocol

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms