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Optimization and evidence-based evaluation of traditional Chinese medicine preparations for external treatment of tumor complications based on "enrichment-permeation-high-efficiency drug release" Taking "Jiangni Zhitu Patch" as an example

Registration number：

ITMCTR2024000624

Date of Last Refreshed on：

2024-10-30

Date of Registration：

2024-10-30

Registration Status：

Prospective registration

Public title：

Optimization and evidence-based evaluation of traditional Chinese medicine preparations for external treatment of tumor complications based on "enrichment-permeation-high-efficiency drug release" Taking "Jiangni Zhitu Patch" as an example

English Acronym：

Scientific title：

Optimization and evidence-based evaluation of traditional Chinese medicine preparations for external treatment of tumor complications based on "enrichment-permeation-high-efficiency drug release" Taking "Jiangni Zhitu Patch" as an example

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xinghan Zhang

Study leader：

Guowang Yang

Applicant telephone：

+86 188 1005 5613

Study leader's telephone：

+86 137 0111 6943

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zxh18810055613@163.com

Study leader's E-mail：

guowang_yang@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

23 Art Gallery Backstreet Dongcheng District Beijing China

Study leader's address：

23 Art Gallery Backstreet Dongcheng District Beijing China

Applicant postcode：

100010

Study leader's postcode：

100010

Applicant's institution：

Beijing Hospital of TCM Capital Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2024BL02-026-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Research Ethical Committee of Beijing Hospital of TCM Capital Medical University

Date of approved by ethic committee：

2024/3/22 0:00:00

Contact Name of the ethic committee：

Sheng Liu

Contact Address of the ethic committee：

23 Art Gallery Backstreet Dongcheng District Beijing China

Contact phone of the ethic committee：

+86 10 8790 6734

Contact email of the ethic committee：

liusheng4377@163.com

Primary sponsor：

Beijing Hospital of TCM Capital Medical University

Primary sponsor's address：

Beijing Hospital of TCM Capital Medical University

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Beijing Institute of Traditional Chinese Medicine

Address：

23 Art Gallery Backstreet, Dongcheng District, Beijing, China

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Beijing Hospital of TCM Capital Medical University

Address：

23 Art Gallery Backstreet Dongcheng District Beijing China

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Beijing University of Chinese Medicine

Address：

Northeast corner of the intersection of Sunshine South Street and Baiyang East Road, Fangshan District, Beijing

Source(s) of funding：

Beijing Hospital Management Center

Target disease：

Chemotherapy-related vomiting

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(cross-over design)

Study phase：

Others

Objectives of Study：

1.major objective To compare the curative effects of new acupoint sticking with standard antiemetic therapy and simple standard antiemetic therapy. 2.Secondary purpose To compare the safety of standard antiemetic therapy assisted by new acupoint sticking and standard antiemetic therapy alone.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Definitely diagnosed as malignant tumor; 2. I am receiving intravenous chemotherapy with moderate vomiting risk and plan to complete at least two cycles; 3. The patient has not received chemotherapy before or it has been more than one month since the last chemotherapy. 4.ECOG/PS score ≤3 and expected survival time > 3 months; 5. Age 18-75 years old; 6. Agree to participate in this study and sign the informed consent form; Definitely diagnosed as malignant tumor;

Exclusion criteria：

1.There are isolated brain/bone/adrenal metastases and radiotherapy is planned; 2.At the same time receive other non-chemotherapy anti-tumor treatments; 3.Nausea and vomiting caused by tumor; 4.Patients with serious diseases of heart liver kidney hematopoietic system and endocrine system; 5.Pregnant or lactating women or the heart lung liver kidney blood and other systems are serious and the researchers think it is not suitable to participate in this study after evaluation; Known allergic to test articles and drugs; The subject is participating in other clinical trials;

Study execute time：

From 2024-08-23

To      2025-06-23

Recruiting time：

From 2024-11-04

To      2025-05-23

Interventions：

48

Group：

The experimental group

Sample size：

Intervention：

New acupoint sticking+western medicine standard antiemetic treatment

Intervention code：

48

Group：

The control group

Sample size：

Intervention：

False acupoint sticking+western medicine standard antiemetic treatment

Intervention code：

Total sample size ： 96

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital of TCM Capital Medical University

Level of the institution：

Tertiary

Outcomes：

Outcome：

Incidence rate above CINV-II level

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

FLIE

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

EQ-5D

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PFS-R

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Evaluation of treatment failure time

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Block random method was used. All patients were randomly divided into two groups by the third-party statistical organization through the block randomized system. Group A (the first stage: standard antiemetic therapy+new acupoint sticking; The second stage: standard antiemetic therapy+fake acupoint sticking) group B (the first stage: standard antiemetic therapy+fake acupoint sticking; The second stage: standard antiemetic therapy+new acupoint sticking). Once the randomized grouping of subjects is completed it will not be changed.

Blinding：

On the packaging boxes of test articles with the same appearance the drug number (1-96) carrying random information shall be marked and the sealed blind bottom (random envelope) and emergency letters shall be kept independently and the latter shall not participate in the research and implementation. After screening and arranging the subjects were assigned drug numbers according to the order of treatment and the drugs were distributed to the subjects by the scientific research pharmacy of the research center. The process of blind editing was completed by independent statisticians and until the end of the study the researchers and subjects remained blind. At the end of the study the subjects were asked to judge their own group through questionnaire survey so as to test whether the research process was successful in maintaining blindness.

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data were collected by researchers in the research center monitored by Beijing Hospital of Traditional Chinese Medicine and the case report form was managed by Beijing Hospital of Traditional Chinese Medicine. Data management is the responsibility of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University. Resman is used to establish a database and two data administrators are responsible for data entry and verification.

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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