A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)

Tasly Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Placebo; Drug: Ginsenoside H dripping pills+Placebo; Drug: Ginsenoside H dripping pills

Study type: Interventional

Funder types: Industry

Identifiers

NCT02714608

TCM0319

Details and patient eligibility

About

Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
2. The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
3. The TCM Syndrome diagnosis of Qi-Deficiency.
4. Aged 18-75 years, both male and female.
5. ECOG performance status 0-2.
6. Expected to survive more than 3 months.
7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion criteria

1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
2. Patients with significant cachexia.
3. Untreated symptomatic brain metastases.

4 .Allergic constitution, or for a variety of drug allergy.

5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.

6. Participated in other clinical trial within 3 months.

7. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.

8. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.

9. Not fit for the clinical trial judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 3 patient groups, including a placebo group

Ginsenoside H dripping pills

Experimental group

Description:

Drug: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.

Treatment:

Drug: Ginsenoside H dripping pills

Ginsenoside H dripping pills+Placebo

Experimental group

Description:

Drug: Ginsenoside H dripping pills ,Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.

Treatment:

Drug: Ginsenoside H dripping pills+Placebo

Placebo

Placebo Comparator group

Description:

Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.

Treatment:

Drug: Placebo