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A placebo control, central randomization, double-blind, multi center phase IIa study for assessment of effect and safety of ginseng secondary glycosides H dripping pills in the treatment of advanced non-small cell lung cancer with Qi deficiency syndrome

A placebo control, central randomization, double-blind, multi center phase IIa study for assessment of effect and safety of ginseng secondary glycosides H dripping pills in the treatment of advanced non-small cell lung cancer with Qi deficiency syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008747
Enrollment
Unknown
Registered
2016-06-29
Start date
2016-06-24
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

Advanced non small cell lung cancer

Interventions

One group:placebo
Two group:high dose
Three group:low dose

Sponsors

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Willing to participate and sign the inform consent; 2. Non small cell lung cancer of stage III B ~ (IV) - stage non small cell lung cancer diagnosed by pathology or cytology; 3. Patients who cannot be treated by surgical resection, conventional radiotherapy or chemotherapy, or who are not willing to accept or tolerate chemotherapy or molecular targeted therapy; 4. With TCM syndrome of qi deficiency syndrome; 5. The physical condition of a ECOG score of 2 or less; 6. Expected survival time in 3 months or more.

Exclusion criteria

Exclusion criteria: 1. Liver and kidney injury; 2. Have obvious evil liquid; 3. Brain metastases with symptoms that are not effectively controlled; 4. Allergic constitution, or allergic to a variety of drugs; 5. Severe heart, liver, renal function injury, pregnancy or breast-feeding women, mental patients; 6. During the experiment, it is possible to carry out systematic chemotherapy, radiation therapy, targeted therapy and so on; 7. The researchers believe that there are some patients who are not fit for the selected factors; 8. During the experiment, it is possible to carry out systematic chemotherapy, radiation therapy, targeted therapy and so on.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
The curative effect of TCM main symptoms;TCM syndrome total score;

Countries

China

Contacts

Public ContactZhang Ying

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University

zhangyinghx@189.cn+86 18980602088

Outcome results

None listed

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