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A clinical study of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis: Study protocol for a randomized controlled trail

A clinical study of Yiqi Huayu Jiedu decoction reducing the risk of postoperative gastric cancer recurrence and metastasis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032802
Enrollment
Unknown
Registered
2020-05-11
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Gastric Cancer

Interventions

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with pathological diagnosis of gastric cancer; (2) Patients with histologically confirmed stage II, III after resection; (3) Patients with criteria of TCM syndrome of Qi deficiency of spleen; (4) KPS scores > 60; (5) Patients aged from 18 to 70 years; (6) Patients with life expectancy of at least 6 months; (7) Patients who provide written informed consent to participate in the study according to the GCP criteria.

Exclusion criteria

Exclusion criteria: (1) Patients with metastatic gastric cancer; (2) Patients with histologically or imaging examination confirmed local recurrence or distant metastasis; (3) Patients who are pregnant, nursing; (4) Patients with severe primary cardiovascular disease, liver disease, kidney disease, blood disease or other diseases affecting survival; (5) Patients with disabilities are prescribed by law, including the blind, the deaf, dysgnosia, mental disturbance and extremity disability; (6) Patients who are alcohol dependence or substance abuse; (7) Patients with situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment; (8) Patients who are allergic constitution,such as those who are allergic to more than 2 drugs and food, or those who are allergic to the ingredients of Jianpi Huayu Jiedu decoction; (9) Patients who are participating in the other clinical trials.

Design outcomes

Primary

MeasureTime frame
1 year progression-free survival rate;2 year progression-free survival rate;disease-free survival;

Secondary

MeasureTime frame
tumor marker;TCM sydrome score;Quality of life;

Countries

China

Contacts

Public ContactLi Zhang

Jiangsu Province Hospital of Chinese Medicine

Leeky83@163.com+86 13813963798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026