Lung CancersNCT06674252
A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
A study testing Jiawei Bufei Tang granules in people with Lung Cancers, run by Peking University Cancer Hospital & Institute at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Cancers
- What is being tested?
- Jiawei Bufei Tang granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
- The heart function is basically normal; ALT/AST is within 2 times the normal value; SCr is within the normal range.
- Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.
Who cannot join
- Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
Xu yi chen, MD, 0086+15801096968, xxxxyc@126.com
Xue Dong, MD
- Recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
Xu yi chen, MD, 0086+15801096968, xxxxyc@126.com
About this study
Official title: A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
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.
Read the detailed description
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.
- Research Design: A multicenter, randomized double-blind placebo-controlled study was conducted, in which eligible subjects were randomly assigned to a treatment group and a control group in a 1:1 ratio, with 87 cases in each group.
- The process of participant participation in the experiment The composition of Jiawei Bu Fei Tang includes Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch lotus, White Hedyotis diffusa, Bai Qian, and Platycodon grandiflorum. A traditional Chinese medicine placebo is formulated with caramel color, dextrin, and bittering agent to create a placebo with an appearance and taste similar to the treatment group's medication. Both the therapeutic drug and placebo were tested using independently packaged non decoction granules produced by the same company and batch.
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.
- Conditions
- Lung Cancers
- Being tested
- Jiawei Bufei Tang granules, Placebo
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiawei Bufei Tang granulesOther
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
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Jiawei Bufei Tang granules |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (3)
QLQ-C30 scale
Compare the QLQ-C30 scale scores before and after the trial between the modified Bufei Decoction group and the placebo group
Measured: 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
Measured: 28 days
DFS
Record the difference in DFS between the modified Bufei Decoction group and the placebo group.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start13 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674252
- Sponsor's protocol ID
- JWBF-1
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
- ClinicalTrials.gov ID
- NCT06674252
- Acronym / sponsor ID
- JWBF-1
- Conditions
- Lung Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Research Design: A multicenter, randomized double-blind placebo-controlled study was conducted, in which eligible subjects were randomly assigned to a treatment group and a control group in a 1:1 ratio, with 87 cases in each group.
- The process of participant participation in the experiment The composition of Jiawei Bu Fei Tang includes Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch lotus, White Hedyotis diffusa, Bai Qian, and Platycodon grandiflorum. A traditional Chinese medicine placebo is formulated with caramel color, dextrin, and bittering agent to create a placebo with an appearance and taste similar to the treatment group's medication. Both the therapeutic drug and placebo were tested using independently packaged non decoction granules produced by the same company and batch.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jiawei Bufei Tang | Experimental | Other: Jiawei Bufei Tang granulesOral 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 | Drug: PlaceboTake placebo granules orally for 28 days, twice a day, 1 pack each time, and the medication must be taken with water. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with postoperative lung cancer who have clear histological or cytological diagnosis.
- Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.
Key exclusion criteria (1 listed)
- Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jiawei Bufei Tang granulesJiawei 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 | Other | Jiawei Bufei Tang |
| Placeboplacebo | Drug | Placebo granules |
Primary outcome
MDASI-TCM scale
Time frame: 28 days
The symptom score results of the MDASI-TCM scale between the oral Chinese medicine group and the placebo group after 28 days of medication.
3 secondary outcomes
QLQ-C30 scale
Time frame: 28 days
CGA assessment
Time frame: 28 days
DFS
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jiawei Bufei Tang granules in people with Lung Cancers, run by Peking University Cancer Hospital & Institute at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu yi chen, MD (0086+15801096968, xxxxyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDASI-TCM scale (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.