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Multicenter Clinical Trial On the effect of shenfu injection on early rehablilitation of patients with digestive tract tumor after surgery

Multicenter Clinical Trial On the effect of shenfu injection on early rehablilitation of patients with digestive tract tumor after surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000130
Enrollment
Unknown
Registered
2008-07-06
Start date
2008-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Digestive tract carcinoma (esophageal carcinoma, gasrtic carcinoma,carcinoma of large intestine)

Interventions

Experimental group (Shen Fu Injection group):1) 5%GNS 250ml plus 50ml Shen Fu Injection is administerd intavenous infusion the day before the limitation operation
2) the same treatment protocol is administered daily for 6 days after operation
Control group (Soluvit group):1) 5%GNS 250ml plus Soluvit 10ml is administerd intavenous on the day before the limitation operation
2) the same treatment protocol is administered daily for 6 days after operation.

Sponsors

Traditioal chinese medicine hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. consertive patients with digestive carcinoma; 2. limitation operations are schudled; 3. Informed consent form signed prior to study ;

Exclusion criteria

Exclusion criteria: 1. process of diagnosis and treatment (limitation operation) are uncertain; 2. patients and family members are hepersensitive to the study,and resistence to explanations and communications; 3. temperature >37.5 degree C, abnormality of the white blood cell count; 4. the diabled patients according to local medical criteria; 5. proved or suspected alcohol or drug abused patients; 6. allergic constitution, allergic history of more than two food or drugs, and proved allergic to the components of shenfu; 7. patients who have been joining other drug clinical trial study; 8. disfunction of vital organ.

Design outcomes

Primary

MeasureTime frame
Pain index;intestinal peristalsis recovery time;length of hospitalization;postperative morbidity and mortality;fatigue index;

Secondary

MeasureTime frame
coagulation function;immune function (IgA, IgM, IgG, CD3, CD4, CD8);biochemical test (glucose, albumin, globulin, creatinine, urea nitrogen, alanine aminotransferase);Complete blood cell count;C reactive protein;QoL;Temperature, heart rate, respiratory rate, blood pressure;

Countries

China

Contacts

Public ContactHuasen Qiu
qhs86@163.com+86 0 13805727122

Outcome results

None listed

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