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A randomized, double blind, placebo-controlled, multicenter trial for Qi Xue Kang oral liquid to improve the efficacy and safety of leukocyte reduction during chemotherapy and chemotherapy in patients with malignant tumors

A randomized, double blind, placebo-controlled, multicenter trial for Qi Xue Kang oral liquid to improve the efficacy and safety of leukocyte reduction during chemotherapy and chemotherapy in patients with malignant tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016825
Enrollment
Unknown
Registered
2018-06-27
Start date
2018-07-15
Completion date
Unknown
Last updated
2018-07-02

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

Conditions

Malignant tumor

Interventions

experimental group:Oral Qi Xue Kang oral liquid
control group:Oral Qi Xue Kang oral liquid placebo

Sponsors

Wangjing Hospital of Chinese Academy of science of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18~75 years, male and female; 2. malignant solid tumor (according to the TNM staging system of the UICC), the tumor type is limited to four types of lung cancer, breast cancer, colorectal cancer and gastric cancer; 3. ECOG score less than 2; 4. before chemoradiotherapy, WBC was more than 4x10^9/L, neutrophils were more than 2 x 10^9/L, and PLT was more than 100x10^9/L; 5. no severe heart, lung, liver, kidney and bone marrow dysfunction; 6. the expected survival to be longer than 3 months; 7. Be willing to cooperate with the trial protocol and with good compliance; 8. voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with multiple bone metastases; 2. patients who are allergic to any test drugs and their adjuvants; 3. alcoholics and drug addicts, with epilepsy or mental disorders; 4. pregnant, lactation, or planned gestation; 5. participating in or participated in other clinical trials within past 3 months; 6. the researchers believe the patient not suitable for the study (such as those with poor glucose control).

Design outcomes

Primary

MeasureTime frame
white blood cell;

Secondary

MeasureTime frame
Red blood cell;Platelet;hemoglobin;Neutrophils;Quality of life score;Fatigue scale;TCM syndrome score;

Countries

China

Contacts

Public ContactShijie ZHU

Wangjing Hospital of Chinese Academy of science of traditional Chinese Medicine

13381058340@163.com+86 13381058340

Outcome results

None listed

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