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The effect of invigorating the spleen, nourishing the body, dispelling the symptoms and dispelling the stagnation method on the nutritional status and intestinal microecology of patients with gastric cancer undergoing chemotherapy

The effect of invigorating the spleen, nourishing the body, dispelling the symptoms and dispelling the stagnation method on the nutritional status and intestinal microecology of patients with gastric cancer undergoing chemotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064547
Enrollment
Unknown
Registered
2022-10-11
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Gastric Cancer

Interventions

Experimental group:Standard chemotherapy regimen combined with Jianpi Yangzhengxiaozheng formula

Sponsors

Jiangsu Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of gastric cancer in western medicine, refer to the NCCN guidelines for pathological stage III and IV gastric cancer, have indications for chemotherapy and are willing to receive chemotherapy; 2. Have not used prebiotics, probiotics, antibiotics and other drugs that affect intestinal flora in the past one month; 3. The TCM syndrome type belongs to the spleen and stomach weakness syndrome; 4. Age between 18-80 years old, gender is not limited; 5. The general condition is acceptable, the KPS score is >= 60 points, and the expected survival time is >= 3 months; 6. The functions of important organs are basically normal; 7. Understand the situation of this study and give informed consent.

Exclusion criteria

Exclusion criteria: 1. Having other primary tumors or combined with immune diseases; 2. Those who cannot eat orally (including digestive tract obstruction, jejunostomy); 3. Those who are allergic to experimental drugs; 4. Those with serious primary diseases or other serious diseases that affect survival, such as severe cardiovascular and cerebrovascular diseases, systemic multiple organ failure, and severe infectious diseases who cannot tolerate chemotherapy; 5. Patients with poor compliance; 6. Pregnant and lactating women; 7. Those who do not meet the inclusion criteria, do not take medication according to regulations, affect the judgment of drug efficacy, or have incomplete data that affect the judgment of curative effect and safety.

Design outcomes

Primary

MeasureTime frame
Gut flora;plasma protein;

Secondary

MeasureTime frame
Gastrointestinal adverse reactions;Numerical rating scale score;TCM syndrome score scale;Karnofsky score;

Countries

China

Contacts

Public ContactJian Wu/Shenlin Liu

Jiangsu Provincial Hospital of Traditional Chinese Medicine

czcyg@sina.com+86 18652042906

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026