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Shuanghuang Shengbai Granules - Efficacy and Safety Evaluation Technology of Traditional Chinese Medicine Compounds Based on Systems Biology

Shuanghuang Shengbai Granules - Efficacy and Safety Evaluation Technology of Traditional Chinese Medicine Compounds Based on Systems Biology

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061371
Enrollment
Unknown
Registered
2022-06-22
Start date
2021-12-30
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

lung adenocarcinoma

Interventions

Healthy control group:no
Placebo control group:Shuanghuang Shengbai granule placebo 15g/ bag (twice a day, 2 bags each time),for 21 days
Treatment group:Shuanghuang Shengbai granule 15g/ bag (twice a day, 2 bags each time),for 21 days

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. patients with pathologically or cytologically confirmed stage III lung adenocarcinoma and first postoperative chemotherapy; 2. meet the criteria for clinical evidence identification in Chinese medicine; 3. patients aged 18 - 85 years old; 4. Patients have undergone NP (vincristine + cisplatin) chemotherapy regimen, protocol description: vincristine (NVB) 25mg/m2 intravenous d1, d8 + cisplatin (DDP) 75mg/m2/d intravenous d1, (21 days for 1 cycle); 5. Patients developed grade I - II myelosuppression after standard NP chemotherapy regimen; the degree of myelosuppression was classified as grade 0 to IV according to WHO: grade 0: leukocytes = 4.0×10^9/L, hemoglobin = 110 g/L, platelets = 100×109/L, grade I: leukocytes (3.0-3.9)×10^9/L, hemoglobin 95-100 g/L, platelets (75 to 99) × 109/L, grade II: leukocytes (2.0 to 2.9) × 10^9/L, hemoglobin 80 to 94 g/L, platelets (50 to 74) × 10^9/L, grade III: leukocytes (1.0 to 1.9) × 10^9/L, hemoglobin 65 to 79 g/L, platelets (25 to 49) × 10^9/L, grade IV: leukocytes (0 to 1.0) × 10^9/L, hemoglobin <65 g/L, platelets <25 × 10^9/L. 6. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with pathologically or cytologically confirmed stage III lung adenocarcinoma and first postoperative chemotherapy. 2. meet the criteria for clinical evidence identification in Chinese medicine 3. patients aged 18 - 85 years old. 4. Patients have undergone NP (vincristine + cisplatin) chemotherapy regimen, protocol description: vincristine (NVB) 25mg/m2 intravenous d1, d8 + cisplatin (DDP) 75mg/m2/d intravenous d1, (21 days for 1 cycle). 5. Patients developed grade I - II myelosuppression after standard NP chemotherapy regimen; the degree of myelosuppression was classified as grade 0 to IV according to WHO: grade 0: leukocytes = 4.0×109/L, hemoglobin = 110 g/L, platelets = 100×109/L, grade I: leukocytes (3.0-3.9)×109/L, hemoglobin 95-100 g/L, platelets ( 75 to 99) × 109/L, grade II: leukocytes (2.0 to 2.9) × 109/L, hemoglobin 80 to 94 g/L, platelets (50 to 74) × 109/L, grade III: leukocytes (1.0 to 1.9) × 109/L, hemoglobin 65 to 79 g/L, platelets (25 to 49) × 109/L, grade IV: leukocytes (0 to 1.0) × 109/L, hemoglobin <65 g/L, platelets <25 × 109/L. 6. Patients who have signed the informed consent form.

Design outcomes

Primary

MeasureTime frame
it is formulated according to the evaluation standard of TCM clinical syndrome score of lung cancer in the clinical guiding principles of new traditional Chinese medicine.;Metabonomics test;

Secondary

MeasureTime frame
Routine blood test;liver function;Renal function;electrocardiogram test;Fecal routine test;urinalysis;

Countries

China

Contacts

Public ContactWenlian Chen

Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine

chenwl8412@163.com+86 13015401126

Outcome results

None listed

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