Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2020-09-15
2022-06-30
Brief Summary
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Detailed Description
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This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a 2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 1:1. On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group. The primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores, clinical symptoms, and change of tumor volume. Safety and adverse events will also be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.
Jing-yan-kang Granule
Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
PC chemotherapy and symptomatic treatment
Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
If necessary, symptomatic treatment will also be used.
Control Group
All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.
PC chemotherapy and symptomatic treatment
Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
If necessary, symptomatic treatment will also be used.
Interventions
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Jing-yan-kang Granule
Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
PC chemotherapy and symptomatic treatment
Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
If necessary, symptomatic treatment will also be used.
Eligibility Criteria
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Inclusion Criteria
* Age ranges from17years to75years.
* A KPS score ≥40.
* Without radiotherapy, immunotherapy and targeted therapy.
* Without participanting in any other trial.
* With signed informed consent.
Exclusion Criteria
* The patient has a history of allergy to any of the components of the intervention drug;
* Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases.
* Unconscious or unable to communicate normally.
* Patients with poor compliance.
18 Years
75 Years
ALL
No
Sponsors
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Henan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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TCM for lung adenocarcinoma
Identifier Type: -
Identifier Source: org_study_id
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