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Clinical study of Shuanghuang Shengbai Oral Liquid for preventing leukopenia after chemotherapy for lung cancer

Clinical study of Shuanghuang Shengbai Oral Liquid for preventing leukopenia after chemotherapy for lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16009398
Enrollment
Unknown
Registered
2016-10-14
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Lung cancer

Interventions

experimental group:Shuanghuang Shengbai Oral Liquid
control group:leucogen Tablets

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) non small cell lung cancer patients diagnosed by pathology or cytology, and researcher think it is suitable for use of pemetrexed combined with carboplatin (PC) regimen; (2) male and female aged 18~75 years old; (3) ECOG physical status score less than 2 points; (4) peripheral blood cell counts were in accordance with the conditions of chemotherapy : white blood cell count over 4 * 109/L, neutrophil count over 2 * 10^9/L; (5) liver function indexes ALT, TBIL and AST were all within 2.5 times of the upper normal limit; (6) renal function index: Cr in the upper limit of the normal value; (7) patients with expected survival of more than 3 months; (8) voluntarily signed written informed consent.

Exclusion criteria

Exclusion criteria: (1) received radiation therapy in the first 4 weeks of the group (2) the existing serious acute infection, and there is no control; or suppurative and chronic infection, wound healing; serious disease of heart, liver, kidney and hematopoietic system; (3) severe mental or neurological disorders affecting informed consent and / or adverse reactions; (3) to participate in other clinical trials in the first 4 months of this trial; (5) suspected of drug abuse, drug abuse, alcoholism; (6) allergies or allergic history of drugs and ingredients; (7) pregnant or lactating women or pregnant women may be pregnant before the first pregnancy test positive; (8) the researchers think that other subjects who are not suitable for the test

Design outcomes

Primary

MeasureTime frame
Incidence and extent of leukocyte reduction;

Secondary

MeasureTime frame
Duration of leukocyte reduction;TCM syndrome score;Quality of life score;Dosage of recombinant human granulocyte colony stimulating factor (rhG-CSF);

Countries

China

Contacts

Public ContactZhongqi Wang

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

aledx@sina.com+86 18917763093

Outcome results

None listed

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