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The clinical trial of the interventional effect of Sini Decoction and Shengxian Quyu Decoction on myocardial inhibition in patients with sepsis

The clinical trial of the interventional effect of Sini Decoction and Shengxian Quyu Decoction on myocardial inhibition in patients with sepsis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003566
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-08-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Sepsis

Interventions

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria of Western medicine: 1. Patients with sepsis: (refer to the latest sepsis diagnostic criteria developed by SSC guidelines in 2016) (1) Suspected or confirmed infection; (2) The sequential organ failure score (SOFA score) increased by 2 or more points above the baseline level, and it could be diagnosed as sepsis. 2. Myocardial suppression: at present, there is no unified diagnostic standard for sepsis myocardial injury at home and abroad. At present, the domestic and foreign literatures are consulted and the diagnosis process recognized by well-known experts is followed. The presence of any of the following is suggestive of myocardial suppression: (1) Myocardial injury markers: c-tni > 0.03ng/ml and c-tnt > 0.017ng/ml. (2) Echocardiography: LVEF 25%. Diagnostic criteria of traditional Chinese Medicine (refer to the TCM classification of sepsis according to the guidelines for the treatment of severe sepsis / septic shock in China issued in 2014) 1. The body is tired and weak, with little Qi and lazy speech, pain in fixed parts, bleeding in some parts, and pain in chest and flank like needle pricking; 2. Light and dark tongue, purple purple or ecchymosis, varicose sublingual veins, and thin or stringy veins; 3. Cold sweat, cold limbs, red face, blue lips, or high fever, coma, etc.; 1. Meet the diagnostic criteria of sepsis myocardial suppression; 2. Syndrome differentiation of TCM is Qi deficiency and blood stasis; 3. Aged 18-85 years; 4. Excluding the patients with previous heart diseases; 5. Patients who voluntarily participated in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe hepatic and renal insufficiency, patients with severe immune diseases or malignant tumors; 2. Patients with allergic constitution or allergic to traditional Chinese medicine decoction; 3. Patients unable to cooperate with the study and patients who died within 24 hours after admission to ICU; 4. Pregnant or lactating women; 5. Patients who participated in other studies.

Design outcomes

Primary

MeasureTime frame
Troponin-T;Echocardiography;pro-BNP;

Secondary

MeasureTime frame
TNF-a;PCT;HMGB1;Qi deficiency and blood stasis scale score;SOFA;28-day mortality;CRP;IL-1ß;APACHE?;

Countries

China

Contacts

Public ContactLiheng Guo

Guangdong Provincial Hospital of Traditional Chinese Medicine

guolh782@163.com+86 20-81887233

Outcome results

None listed

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