NSCLCPhase 1NCT06766565
QYJD Compound Preparation Promotes Rapid Postoperative Recovery in Early-stage NSCLC Patients by Regulating Tissue Microecology: a Prospective, Randomized Controlled, Open-label, Phase I Clinical Study With Predefined Future Exploration
A Phase 1 study testing QYJD Compound Preparation in people with NSCLC, run by Fuzhou General Hospital at 1 site in China.
Trial summary
QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- QYJD Compound Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2021to 8 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with (a) no contraindications to surgery, early stage NSCLC diagnosed by postoperative pathology, and clinical stage I-IIIA; (b) aged 18-80 years old, with KPS score ≥60; (c) with expected survival of more than 3 months; (d) with no history of smoking; (e) with no previous underlying lung diseases such as bronchiectasis, bronchial asthma, or COPD; (f) without neoadjuvant chemotherapy; (g) with no previous treatment with neoadjuvant chemotherapy; (h) with no previous treatment with neoadjuvant chemotherapy; (i) with no previous treatment with bronchodilatation, bronchial asthma, or COPD; (j) with no previous treatment with neoadjuvant chemotherapy. (f) No neoadjuvant chemotherapy; (g) No history of other systemic malignancies; (h) Sufficient fresh tumor tissue specimens are available.
- Participants are willing to participate in this study and comply with the study plan;
- Participants or legally authorized representatives were able to provide written informed consent approved by the ethical review board managing the site.
Who cannot join
- the presence of malignant tumors or metastatic foci in other parts of the body;
- the combination of other organic diseases;
- psychiatric disorders or communication disorders;
- lung infections, systemic hematologic diseases, immune system diseases;
- bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases;
- within the past month, there are antibiotics, immunosuppressive drugs, hormones, probiotics, as well as any those who have taken antibiotics, immunosuppressants, hormones, probiotics, and any form of traditional Chinese medicine or proprietary Chinese medicine within the past month;
- Those who have a history of smoking;
- Those who have a history of occupational or environmental exposure to dust, mines, or asbestos.
Trial locations and contacts
1 site in 1 country.
About this study
QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small cell lung cancer (NSCLC) by using metagenomics next-generation sequencing (mNGS) technology to carry out a prospective phase I clinical study. The aim of the study was to investigate the effect of the expelling stasis and detoxifying compound preparation on the microecology of lungs of patients with early-stage non-small cell lung cancer (NSCLC), and to conduct a prospective phase I clinical study to provide new ideas for promoting the postoperative rehabilitation of early-stage NSCLC.
Read the detailed description
- participants screened for eligibility should sign the appropriate Informed Consent Form (ICF) prior to completing any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- Conditions
- NSCLC
- Being tested
- QYJD Compound Preparation
- Keywords
- QYJD Compound Preparation, clinical trials, rapid rehabilitation, lung tissue microecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QYJD Compound PreparationDrug
The intervention group was treated with 2 capsules (g) of expelling stasis and QYJD compound preparation orally for 4 days before thoracoscopic radical surgery for lung cancer, 3 times a day. The blank control group had no oral drug treatment before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Blank control group | No intervention | Group1 There was no oral drug treatment before surgery. Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis. |
| QYJD Compound Preparation intervention group | Experimental | Group2 In the treatment group, the patients were orally treated with expelling blood stasis and detoxifying compound preparation for 4 days before thoracoscopic radical lung cancer surgery, 2 capsules (0.3g/capsule) at a time, 3 times a day, with lukewarm water, for a total of 4 days.Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis. Receives: Drug: QYJD Compound Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid rehabilitation indexes
the number of days of postoperative chest drain retention
Measured: 15 days
Rapid rehabilitation indexes
postoperative pain VAS scores
Measured: 1 week
Rapid rehabilitation indexes
six-minute walking experiments
Measured: 7 day
Laboratory indicators of inflammation
including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start8 Dec 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766565
- Sponsor's protocol ID
- 2021-026
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QYJD Compound Preparation Promotes Rapid Postoperative Recovery in Early-stage NSCLC Patients by Regulating Tissue Microecology: a Prospective, Randomized Controlled, Open-label, Phase I Clinical Study With Predefined Future Exploration
- ClinicalTrials.gov ID
- NCT06766565
- Acronym / sponsor ID
- 2021-026
- Conditions
- NSCLC
- Keywords
- QYJD Compound Preparation, clinical trials, rapid rehabilitation, lung tissue microecology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 9 Jan 2025 (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.
QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small cell lung cancer (NSCLC) by using metagenomics next-generation sequencing (mNGS) technology to carry out a prospective phase I clinical study. The aim of the study was to investigate the effect of the expelling stasis and detoxifying compound preparation on the microecology of lungs of patients with early-stage non-small cell lung cancer (NSCLC), and to conduct a prospective phase I clinical study to provide new ideas for promoting the postoperative rehabilitation of early-stage NSCLC.
Detailed description
- participants screened for eligibility should sign the appropriate Informed Consent Form (ICF) prior to completing any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blank control group | No intervention | –Group1 There was no oral drug treatment before surgery. Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis. |
| QYJD Compound Preparation intervention group | Experimental | Drug: QYJD Compound PreparationGroup2 In the treatment group, the patients were orally treated with expelling blood stasis and detoxifying compound preparation for 4 days before thoracoscopic radical lung cancer surgery, 2 capsules (0.3g/capsule) at a time, 3 times a day, with lukewarm water, for a total of 4 days.Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with (a) no contraindications to surgery, early stage NSCLC diagnosed by postoperative pathology, and clinical stage I-IIIA; (b) aged 18-80 years old, with KPS score ≥60; (c) with expected survival of more than 3 months; (d) with no history of smoking; (e) with no previous underlying lung diseases such as bronchiectasis, bronchial asthma, or COPD; (f) without neoadjuvant chemotherapy; (g) with no previous treatment with neoadjuvant chemotherapy; (h) with no previous treatment with neoadjuvant chemotherapy; (i) with no previous treatment with bronchodilatation, bronchial asthma, or COPD; (j) with no previous treatment with neoadjuvant chemotherapy. (f) No neoadjuvant chemotherapy; (g) No history of other systemic malignancies; (h) Sufficient fresh tumor tissue specimens are available.
- Participants are willing to participate in this study and comply with the study plan;
- Participants or legally authorized representatives were able to provide written informed consent approved by the ethical review board managing the site.
Key exclusion criteria (8 listed)
- the presence of malignant tumors or metastatic foci in other parts of the body;
- the combination of other organic diseases;
- psychiatric disorders or communication disorders;
- lung infections, systemic hematologic diseases, immune system diseases;
- bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases;
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 |
|---|---|---|
| QYJD Compound PreparationThe intervention group was treated with 2 capsules (g) of expelling stasis and QYJD compound preparation orally for 4 days before thoracoscopic radical surgery for lung cancer, 3 times a day. The blank control group had no oral drug treatment before surgery. | Drug | QYJD Compound Preparation intervention group |
Primary outcome
Rapid rehabilitation indexes
Time frame: 15 days
the number of days of postoperative chest drain retention
Rapid rehabilitation indexes
Time frame: 1 week
postoperative pain VAS scores
Rapid rehabilitation indexes
Time frame: 7 day
six-minute walking experiments
Laboratory indicators of inflammation
Time frame: through study completion, an average of 1 year
including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QYJD Compound Preparation in people with NSCLC, run by Fuzhou General Hospital at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid rehabilitation indexes (time frame: 15 days). The study lists 4 primary outcomes in all. 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 9 Jan 2025.