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Traditional Chinese Medicine Jian Pi Jie Du Granules - Efficacy and Safety Evaluation Technology of Traditional Chinese Medicine Compounds Based on Systems Biology

Traditional Chinese Medicine Jian Pi Jie Du Granules - Efficacy and Safety Evaluation of herbal medicine formula Based on Systems Biology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000995
Enrollment
Unknown
Registered
2025-05-15
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Esophageal squamous cell carcinoma

Interventions

Patient control group:It is treated according to the current clinical routine method and no drug intervention is done.
Healthy control group:no
Patient treatment group:Jian Pi Jie Du Granules 6g/pack (2 times a day 1 pack each time oral) 21 days of continuous medication for 1 course of treatment

Sponsors

Cancer Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pathological or cytological diagnosis of stage II. or III. primary esophageal squamous cell carcinoma and have undergone the first postoperative chemotherapy. 2. Comply with the clinical syndrome differentiation standards of traditional Chinese medicine. 3. Age = 18 years old and = 85 years old good compliance. 4. The patient underwent TP (paclitaxel + cisplatin) chemotherapy regimen and the protocol description: paclitaxel (PTX) 210mg/m2 intravenous infusion d1 + cisplatin (DDP) 30mg/m2/d intravenous infusion d1-3 (21 days for 1 cycle). 5. The patient developed spleen deficiency syndrome after standard TP chemotherapy regimen. 6. The subject has no dysfunction of major organs and has normal blood routine liver kidney and heart functions. 7. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal thyroid function diabetes or hypertension. 2. Abnormal liver function (alanine aminotransferase aspartate aminotransferase total/direct/indirect bilirubin bile acids etc.) and/or abnormal renal function (urea creatinine uric acid etc.). 3. Mentally ill people. 4. Pregnant or lactating women. 5. History of other tumors within 5 years. 6. Have a family history of genetic disease.

Design outcomes

Primary

MeasureTime frame
Quality of life;

Secondary

MeasureTime frame
Metabonomics test;Routine blood test;TCM syndrome;Vital signs;Fecal routine;Blood biochemistry;electrocardiogram;Urinalysis;

Countries

China

Contacts

Public ContactGuo-Hua Wei

Cancer Hospital of Nantong University

nini050808@163.com13584648895

Outcome results

None listed

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