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This is a randomized double-blind placebo-controlled phase II clinical study that included patients with symptoms such as cough, shortness of breath, and fatigue after lung cancer resection surgery. They were given orally modified Bufei Tang granules twice a day for 28 days, with one packet taken orally with water. Using the MDASI-TCM symptom scoring system, evaluate the scores of symptoms such as cough, shortness of breath, and fatigue before and after the experiment, and calculate the difference in scores between the control group and the experimental group before and after the experiment.
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to verify the effectiveness of the traditional Chinese medicine compound Jiawei Bufei Tang in improving postoperative clinical symptoms in elderly lung cancer patients and providing effective treatment methods for improving patients' quality of life.
On the 7th day after surgery, patients were screened and evaluated using the MDASI-TCM scale. Subjects with postoperative symptoms such as fatigue, cough, and shortness of breath who met the inclusion criteria but did not meet the exclusion criteria were included in the clinical study and randomly assigned to receive oral medication treatment in a 1:1 ratio.
On the day of inclusion, the patient was randomized and successfully received the trial medication, with the first oral administration of traditional Chinese medicine within 24 hours.
Treatment group (Modified Bufei Decoction):
Usage of traditional Chinese medicine: Take orally 1 bag/time of Jiawei Bufei Tang, twice a day, starting from the 7th day after surgery (the day of enrollment), for 28 consecutive days.
Control group (placebo):
Usage of placebo: Take 1 bag of placebo orally, twice a day, starting from the 7th day after surgery (the day of enrollment), for 28 consecutive days.
If the subject experiences discomfort during the medication process, unblinding or withdrawal from the study can be based on the researcher's judgment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jiawei Bufei Tang | Experimental | Oral administration of Jiawei Bufei Tang granules for 28 days, twice a day, 1 packet each time, and the medication must be taken with water. |
|
| Placebo granules | Placebo Comparator | Take placebo granules orally for 28 days, twice a day, 1 pack each time, and the medication must be taken with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jiawei Bufei Tang granules | Other | Jiawei Bufei Tang is a traditional Chinese medicine formula applied by Professor Li Pingping to patients with lung cancer and qi yin deficiency syndrome. It consists of Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch Lotus, White Hedyotis diffusa, etc. Bu Fei Tang is derived from the Yuan Dynasty's "Yong Lei Ling Fang" and consists of six ingredients: ginseng, astragalus, schisandra, Radix Rehmanniae, Ziyuan, and mulberry bark. It is mainly used to treat cough caused by lung qi deficiency. Jiawei Bufei Tang adds white Hedyotis diffusa, Scutellaria barbata, and snake berry to the original formula. White Hedyotis diffusa is more effective in dispelling carbuncles and detoxifying, Scutellaria barbata is more effective in dispelling phlegm and diuresis, and snake berry is more effective in dispelling scrofula and dispersing nodules, increasing the effect of clearing heat and detoxifying. This formula is particularly e |
| Measure | Description | Time Frame |
|---|---|---|
| MDASI-TCM scale | The symptom score results of the MDASI-TCM scale between the oral Chinese medicine group and the placebo group after 28 days of medication. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| QLQ-C30 scale | Compare the QLQ-C30 scale scores before and after the trial between the modified Bufei Decoction group and the placebo group | 28 days |
| CGA assessment | Compare the CGA assessment results of elderly patients before and after the trial between the modified Bufei Decoction group and the placebo group |
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Inclusion Criteria:
Patients with postoperative lung cancer who have clear histological or cytological diagnosis.
Age ≥ 65 years old, both male and female are eligible. According to the MDASI-TCM scale evaluation, any of the three symptoms of cough, fatigue, and shortness of breath should score ≥ 4 points, or the sum of the three should score ≥ 6 points.
Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu yi chen, MD | Contact | 0086+15801096968 | xxxxyc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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|
| Placebo | Drug | placebo |
|
| 28 days |
| DFS | Record the difference in DFS between the modified Bufei Decoction group and the placebo group. | 28 days |
| Beijing cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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