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Clinical trial for Chunyangzhengqi capsule in the treatment of gastrointestinal reaction caused by tumor chemotherapy

Clinical trial for Chunyangzhengqi capsule in the treatment of gastrointestinal reaction caused by tumor chemotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017852
Enrollment
Unknown
Registered
2018-08-17
Start date
2018-08-15
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

gastrointestinal reaction caused by tumor chemotherapy

Interventions

Experimental group:Chunyangzhengqi capsule
Control:Prosetron or palm oxisetron

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Clinical pathological histology or cytological diagnosis of breast cancer, lung cancer (non squamous cell carcinomas) or patients with gastric cancer, there are indications of chemotherapy without contraindications, need chemotherapy for the first time or need postoperative adjuvant chemotherapy; (2) Diagnosis of traditional Chinese medicine belongs to cold dampness trapped spleen; (3) Aged from 18 to 75 years old (including boundary value); KPS score 60 or more; expected survive period for 3 months or more; (4) Patients who will be proposed to traditional recommended chemotherapy regimens of various malignant tumors of the gastrointestinal side effects (namely breast cancer chemotherapy regimens including cisplatin and doxorubicin treatment;Patients with lung cancer chemotherapy regimens for pemetrexed combined cisplatin treatment;Patients with gastrointestinal cancer chemotherapy regimens for vertical or oxaliplatin into Iraq for joint 5 - FU kang treatment); (5) Patients who no important organ dysfunction, laboratory examination satisfies the basic demands of chemotherapy; (6) patients can understand and abide by this research program, and sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: (1) Patients who cannot feed through the mouth; (2) Patients who late critically and expected lifetime < 3 months; (3) Patients who obstruction and infection of the digestive tract or other serious Cardia-cerebrovascular Disease; (4) Patients who have central nervous system transfer or emesis caused by intracranial pressure; (5) Add radiation therapy with affect curative effect observation of emesis and other drugs that may influence the antemetic effect (such as omeprazole, ammonium phosphate, metoclopramide, stable and promethazine, etc); (6) Patients who used antemetic drugs or related drugs in 24 hours(such as vitamin B6, dexamethasone, ding Lin and metoclopramide, etc.) or have emesis before chemotherapy; (7) Patients who severe pain need morphine drugs; (8) Patients who irritability for studying drugs; (9) patinets with gestation and location period; (10) Researchers consider other situation that cannot into the group.

Design outcomes

Primary

MeasureTime frame
Symptoms grade of nausea and emesis;

Secondary

MeasureTime frame
Symptoms grade of abdominal pain and diarrhea;

Countries

China

Contacts

Public ContactHanping Shi

Beijing Shijitan Hospital, Capital Medical University

shihp@vip.163.com+86 13802741263

Outcome results

None listed

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