Pricking Therapy on the Back Shu PointsNCT06074718
Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer
A study testing pricking therapy and wheat grain moxibustion in people with Pricking Therapy on the Back Shu Points and Wheat Grain Moxibustion on the Back Shu Points, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial summary
This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pricking Therapy on the Back Shu Points, Wheat Grain Moxibustion on the Back Shu Points
- What is being tested?
- pricking therapy and wheat grain moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2024to Sep 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;
- Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;
- Good compliance and signed informed consent form.
Who cannot join
- Patients who cannot lie prone for a long time;
- Pregnant women;
- Lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingtao Ni
Taizhou, Jiangsu, 225300
Qingtao Ni, 18852656280, nqt1990@126.com
About this study
Official title: Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type
This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.
- Being tested
- pricking therapy and wheat grain moxibustion
- Keywords
- spleen deficiency and dampness obstructed, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pricking therapy and wheat grain moxibustionOther
pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points
| Study group | Role | What they receive |
|---|---|---|
| pricking therapy and wheat grain moxibustion combined with chemotherapy | Experimental | pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points combined with chemotherapy Receives: Other: pricking therapy and wheat grain moxibustion |
| chemotherapy | Active comparator | Conventional chemotherapy regimen Receives: Other: pricking therapy and wheat grain moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (ORR)
Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1
Measured: 3 years
Secondary outcomes (3)
progression free survival (PFS),
Evaluate subjects' progression free survival (PFS), overall survival (OS), and duration of remission (DOR) based on RECIST V1.1
Measured: 5 years
overall survival (OS)
Evaluate subjects' overall survival (OS) based on RECIST V1.1
Measured: 5 years
duration of remission (DOR)
Evaluate subjects' duration of remission (DOR) based on RECIST V1.1
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start2 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pricking Therapy on the Back Shu PointsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, niqingtao, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074718
- Sponsor's protocol ID
- JiangsuTaizhouPH
- Status last verified
- May 2024
- First submitted
- 12 Sep 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type
- ClinicalTrials.gov ID
- NCT06074718
- Acronym / sponsor ID
- JiangsuTaizhouPH
- Keywords
- spleen deficiency and dampness obstructed, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Oct 2023 (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 study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pricking therapy and wheat grain moxibustion combined with chemotherapy | Experimental | Other: pricking therapy and wheat grain moxibustionpricking therapy and wheat grain moxibustion on the back shu points or positive reaction points combined with chemotherapy |
| chemotherapy | Active comparator | Other: pricking therapy and wheat grain moxibustionConventional chemotherapy regimen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors;
- Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine;
- Good compliance and signed informed consent form.
Key exclusion criteria (3 listed)
- Patients who cannot lie prone for a long time;
- Pregnant women;
- Lactating women
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 |
|---|---|---|
| pricking therapy and wheat grain moxibustionpricking therapy and wheat grain moxibustion on the back shu points or positive reaction points | Other | chemotherapy, pricking therapy and wheat grain moxibustion combined with chemotherapy |
Primary outcome
Progression-Free Survival (ORR)
Time frame: 3 years
Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1
3 secondary outcomes
progression free survival (PFS),
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
duration of remission (DOR)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pricking therapy and wheat grain moxibustion in people with Pricking Therapy on the Back Shu Points and Wheat Grain Moxibustion on the Back Shu Points, run by Jiangsu Taizhou People's 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 3 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingtao Ni (18852656280, nqt1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (ORR) (time frame: 3 years). 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 May 2024.