The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

Registration number:

ITMCTR2100004923

Date of Last Refreshed on:

2021-06-08

Date of Registration:

2021-06-08

Registration Status:

Retrospective registration

Public title:

The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

English Acronym:

Scientific title:

The clinical standardization study on the treatment of spleen deficiency syndrome after repeated respiratory tract infection by the method of cultivating earth to generate gold

Scientific title acronym:

Study subject ID:

15401970800

The registration number of the Partner Registry or other register:

ChiCTR2100047128 ; ChiMCTR2100004923

Applicant:

Li Hua

Study leader:

Li Hua

Applicant telephone:

+86 021-5296581

Study leader's telephone:

+86 021-5296581

Applicant Fax:

Study leader's fax:

Applicant E-mail:

drlihua502@126.com

Study leader's E-mail:

drlihua502@126.com

Study leader's website(voluntary supply):

http://www.shchildren.com.cn/

Study leader's website
(voluntary supply):

Applicant address:

24 1400th Lane, Beijing Road West, Shanghai, China

Study leader's address:

24 1400th Lane, Beijing Road West, Shanghai, China

Applicant postcode:

200040

Study leader's postcode:

200040

Applicant's institution:

Children's Hospital of Shanghai

Approved by ethic committee:

Approved No. of ethic committee:

2015R017-F02

Approved file of Ethical Committee:

View

Name of the ethic committee:

Shanghai Children's Hospital Ethics Committee

Date of approved by ethic committee:

2015/11/23 0:00:00

Contact Name of the ethic committee:

Xi Yiqun

Contact Address of the ethic committee:

24 1400th Lane, Beijing Road West, Shanghai, China

Contact phone of the ethic committee:

+86 21 52976581

Contact email of the ethic committee:

Primary sponsor:

Children's Hospital of Shanghai

Primary sponsor's address:

24 1400th Lane, Beijing Road West, Shanghai, China

Secondary sponsor:

Country:

China

Province:

Shanghai

City:

Institution
hospital:

Children's Hospital of Shanghai

Address:

24 1400th Lane, Beijing Road West

Source(s) of funding:

Shanghai Municipality's three-year action plan for further accelerating the development of Chinese medicine

Target disease:

Spleen deficiency syndrome after recurrent respiratory tract infection in children

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Pilot clinical trial

Objectives of Study:

To observe the effect of Modified Ginseng-Schisandra Decoction on serum trace elements and immune function in children with spleen deficiency syndrome after recurrent respitatory tract infection.

Description for medicine or protocol of treatment in detail:

1 Data and Methods This study was discussed and approved by the ethics committee of Shanghai Children's Hospital (children's Hospital Affiliated to Shanghai Jiaotong University). 1. Case selection (1)Inclusion criteria 1) The diagnosis of children's recurrent respiratory tract infection was in accordance with the relevant standards formulated by the scientific branch of Chinese Medical Association [7]; 2) The diagnosis of spleen deficiency syndrome in traditional Chinese medicine was in accordance with the relevant literature standards [4]; 3) the age was 1-12 years old, regardless of gender; 4) The family members of the patients gave informed consent. (2)Exclusion criteria 1)Patients with serious diseases such as heart, brain, liver, kidney and hematopoietic system; 2)Patients with repeated respiratory infections caused by tuberculosis, foreign bodies in the bronchus, congenital diseases, etc.; 3)Patients with mental illness. 2. General information A total of 80 children with spleen deficiency syndrome after repeated respiratory infections who were admitted to the Department of Traditional Chinese Medicine of Shanghai Children's Hospital from June 2019 to May 2020 were included in this study. They were randomly divided into observation group and control group, with 40 cases in each group. Among them, there were 23 males and 17 females in the observation group, aged 3-12 years old, with an average of (6.50±2.81) years old; 28 males and 12 females in the control group, aged 3-12 years old, with an average of (6.83±2.26) year old. The difference in baseline data between the two groups of children was not statistically significant (P>0.05), and they were comparable. 3. Treatment methods Children in the control group were treated with Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines,Live (Mamiai, Beijing Hanmei Pharmaceutical Co., Ltd., approval number: National Medicine Standard 30002270S). Usage and dosage: 1 bag each time, 1 or 2 times a day, with warm water for under 2 years old; 1 or 2 bags each time, 1 or 2 times a day, with warm water for more than 2 years old. The course of treatment is 4 weeks. Children in the treatment group were treated with Modified Ginseng-Schisandra Decoction .The basic prescription is composed of Radix astragali(6g)Codonopsis pilosula(6g) Atractylodes macrocephala Koidz.(6g) Poria cocos(9g) Schisandra(3g) Ophiopogon japonicus(6g)oyster(15g) Radix Glycyrrhizae Preparate(3g)Saposhnikovia divaricata(10g) and it should be added or subtracted based on clinical symptoms.The Modified Ginseng-Schisandra Decoction for children is a traditional Chinese medicine decoction-free granule (produced by Jiangyin Tianjiang Pharmaceutical Co., Ltd.). The usage is as follows: 1 to 2 years old, 2 times/d, 1/3 doses/time; 3 to 6 years old , 2 times/d, 0.5 dose/time;> 6 years old, 2 times/d, 1 dose/time. Take it with boiling water after a meal for 4 weeks. 4. Observation items and efficacy evaluation standards (1) TCM syndrome scores Before and after treatment, a scoring method is used to observe the TCM syndromes. The main symptoms (lack of food and appetite, nausea and vomiting, excessive sweating and fatigue, loose stools) are scored as 0, 2, 4, and 6 points according to no, mild, moderate, and severe. (2) Clinical efficacy After the course of treatment, refer to the relevant standard efficacy in the "Guiding Principles for Clinical Research of New Chinese Medicines" to determine the clinical efficacy. 1) Clinical recovery: TCM syndrome score reduction >= 95%; 2) Significant effect: TCM syndrome score reduction >= 70%; 3) Effective: TCM syndrome score reduction >= 30%; 4) Ineffective: TCM syndrome score reduction < 30%. (3) Laboratory indicators Test the children's serum immunoglobulin, T lymphocyte subsets and trace element indicators before and after treatment. 5. Statistical methods SPSS 21.0 software was used for statistical analysis of the data in this study. Measurement data are expressed as mean ± standard deviation (±s), using t test; rank data using rank sum test. P < 0.05 indicates that the difference is statistically significant.

Inclusion criteria

1. The diagnosis of children's recurrent respiratory tract infection was in accordance with the relevant standards formulated by the scientific branch of Chinese Medical Association ; 2. The diagnosis of spleen deficiency syndrome in traditional Chinese medicine was in accordance with the relevant literature standards; 3. Aged 1 to 12 years, regardless of gender; 4. The family members of the patients gave informed consent.

Exclusion criteria:

1. Patients with serious diseases such as heart, brain, liver, kidney and hematopoietic system; 2. Patients with repeated respiratory infections caused by tuberculosis, foreign bodies in the bronchus, congenital diseases, etc.; 3. Patients with mental illness.

Study execute time:

From 2015-07-01

To      2018-09-30

Recruiting time:

From 2015-07-01

To      2018-09-30

Interventions:

40

Group:

Treatment group

Sample size:

Intervention:

Modified Ginseng-Schisandra Decoction

Intervention code:

40

Group:

Control group

Sample size:

Intervention:

Combined Bacillus Subtilis and Enterococcus Faecium Granules with Multivitamines,Live (Mamiai)

Intervention code:

Total sample size : 80

Countries of recruitment
and research settings:

Country:

China

Province:

Shanghai

City:

Jing'an District

Institution/hospital:

Children's Hospital of Shanghai

Level of the institution:

Tertiary A Hospital

Outcomes:

Outcome:

serum immunoglobulin

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

T lymphocyte subsets

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

TCM syndrome scores

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

trace element indicators

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Clinical efficacy

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

serum

Tissue:

Fate of sample 

Destruction after use

Note:

Completed

3
Min age years
12
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

The children were randomly divided into treatment group and control group, and numbered with random number table.

Blinding:

Not stated

IPD sharing:

Yes

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

Within 6 months after the completion of the test, the original data can be obtained through the email: drlihua502@126.com

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

Electronic Data Capture, EDC

Data Managemen Committee:

Not yet

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above