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A randomized, double-blind, controlled, small-sample clinical trial study protocol on the treatment of elderly patients with pulmonary sepsis using Fuzheng Xuanfei Jiedu Granules

A randomized, double-blind, controlled, small-sample clinical trial study protocol on the treatment of elderly patients with pulmonary sepsis using Fuzheng Xuanfei Jiedu Granules

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000036
Enrollment
Unknown
Registered
2026-01-09
Start date
2023-06-30
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary sepsis

Interventions

Control group:Adopt conventional Western medical treatment The plan refers to the 2016 Sepsis3.0 guidelines and "2014 Guidelines for the Treatment of Severe Sepsis/Septic Shock in China, Guidelines fo
Fuzheng Xuanfei Jiedu Granules group:Based on the Western medical intervention plan, Fuzheng Xuanfei Jiedu Granules (15g of ginseng, 9g of notoginseng, 3g of raw rhubarb, 15g of Trichosanthes kirilowi

Sponsors

University Town Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for sepsis SEPSIS 3.0; 2) Age 65-85 years old; 3) Meet the diagnostic criteria for pulmonary infection, referring to the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia" and the "Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Chinese Adults (2018 Edition)". 4) Informed consent of the patient and their family. Meeting criteria 1) to 4) means meeting the inclusion criteria.

Exclusion criteria

Exclusion criteria: 1) Those with severe conditions requiring cardiopulmonary resuscitation; 2) Patients with advanced malignant tumors and cachexia; 3) Those with acute coronary artery disease, such as acute myocardial infarction, etc. 4) Those who are allergic to the taste of the traditional Chinese medicine in the Fuzheng Xuanfei Jiedu Granules prescription or have an allergic constitution; 5) Pregnant women; 6) Participated in other clinical experimenters in the past three months; Clinical researchers consider there to be other circumstances that make participation in the study unsuitable. If any one of the conditions 1) to 6) is met, it can be excluded.

Design outcomes

Primary

MeasureTime frame
Mechanical ventilation time;

Secondary

MeasureTime frame
Length of stay in the ICU;28-day mortality rate;7-day mortality rate;SOFA score;Inflammatory indicators;T lymphocyte subsets;Incidence of adverse reactions;Oxygenation index;APACHE II score;Length of hospital stay;

Countries

China

Contacts

Public ContactYe Ye

Emergency Department, University Town, Guangdong Provincial Hospital of Traditional Chinese Medicine

1004548400@qq.com+86 138 2977 1866

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026