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Role and mechanism of ginseng-ling-white-jujutsu soup in chemotherapy-associated myasthenia gravis of intestinal cancer with spleen deficiency and dampness evidence

Registration number：

ITMCTR2024000854

Date of Last Refreshed on：

2024-12-22

Date of Registration：

2024-12-22

Registration Status：

Prospective registration

Public title：

Role and mechanism of ginseng-ling-white-jujutsu soup in chemotherapy-associated myasthenia gravis of intestinal cancer with spleen deficiency and dampness evidence

English Acronym：

Scientific title：

Role and mechanism of ginseng-ling-white-jujutsu soup in chemotherapy-associated myasthenia gravis of intestinal cancer with spleen deficiency and dampness evidence

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jin Huang

Study leader：

Jin Huang

Applicant telephone：

15256071178

Study leader's telephone：

15256071178

Applicant Fax：

Study leader's fax：

Applicant E-mail：

342647302@qq.com

Study leader's E-mail：

342647302@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

1111 Xianxia Road Tongren Hospital Shanghai China

Study leader's address：

1111 Xianxia Road Tongren Hospital Shanghai China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shanghai Tongren Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2024-076-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Shanghai Tongren Hospital

Date of approved by ethic committee：

2024/10/30 0:00:00

Contact Name of the ethic committee：

chunyan Wang

Contact Address of the ethic committee：

1/F GCP Building 419 Hami Road

Contact phone of the ethic committee：

18217012776

Contact email of the ethic committee：

trhospitalethics@163.com

Primary sponsor：

Shanghai Tongren Hospital

Primary sponsor's address：

1111 Xianxia Road Tongren Hospital Shanghai China

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Changning district central Shanghai

Institution
hospital：

Shanghai Tongren Hospital

Address：

1111 Xianxia Road Tongren Hospital Shanghai China

Source(s) of funding：

self-finance

Target disease：

Colorectal cancer sarcopenia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To investigate the clinical efficacy of Ginseng and Atractylodes Macrocephalae Soup on patients with myasthenia gravis with spleen deficiency and dampness evidence after postoperative chemotherapy for colorectal cancer and to confirm whether Ginseng and Atractylodes Macrocephalae Soup can improve myasthenia gravis and reduce the level of inflammatory factors in the organism.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Postoperative pathology confirmed the diagnosis of colon cancer and supplemented with chemotherapy; ② Meet the diagnostic criteria of postoperative chemotherapy XELOX program and spleen deficiency and dampness syndrome of colon cancer: primary symptoms: poor appetite tiredness fatigue gastrointestinal and abdominal distension or pain vomiting loose stools or diarrhea; secondary symptoms: yellowish color head and body drowsiness fatigue and laziness bland mouth and no thirst. Diagnosis can be made if there are two primary symptoms and one secondary symptom or one primary symptom and two secondary symptoms; ③ Meet the diagnostic criteria of sarcopenia: according to the latest diagnostic criteria of AWGS2019 muscle mass reduction is represented by ASMI <7.0kg/m2 for men and ASMI <5.7kg/m2 for women; muscle strength reduction is represented by grip strength <28kg for men and grip strength <18kg for women; and somatic function reduction is represented by 6m walking speed <1.0m/s. The diagnosis of sarcopenia can be fulfilled by a decrease in muscle mass with a decrease in muscle strength and/or a decrease in somatic function.

Exclusion criteria：

① preoperative radiotherapy or other immunotherapy etc.; ② with heart liver kidney and other important organs failure. ② Patients with heart liver kidney and other important organ failure; ③ Patients with physical deformities that cannot be tested for muscle strength or physical fitness.

Study execute time：

From 2024-11-15

To      2027-11-15

Recruiting time：

From 2024-12-31

To      2025-12-31

Interventions：

30

Group：

experimental group

Sample size：

Intervention：

Oral Ginseng and Atractylodes Macrocephalae Soup

Intervention code：

30

Group：

control subjects

Sample size：

Intervention：

No Ginseng and Atractylodis Macrocephalae.

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Changning district central Shanghai

Institution/hospital：

Shanghai Tongren Hospital

Level of the institution：

Level 3B hospital

Outcomes：

Outcome：

Appendicularskeletalmusclemass

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Body fat percentage

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Muscle Strength

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

BMI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

6-meter walking speed

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

hematology

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Using SPSS Random Number Generation

Blinding：

IPD sharing：

Yes

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

no

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

CRF

Data Managemen Committee：

Yes

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

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