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Exploring the clinical efficacy of Feng's Nie-Ji combined with Xiaoji Powder and Huapi Ointment in treating stagnation (spleen deficiency and accumulation syndrome) and its impact on gut microbiota based on 16S rDNA sequencing technology

Registration number：

ITMCTR2024000511

Date of Last Refreshed on：

2024-10-05

Date of Registration：

2024-10-05

Registration Status：

Prospective registration

Public title：

Exploring the clinical efficacy of Feng's Nie-Ji combined with Xiaoji Powder and Huapi Ointment in treating stagnation (spleen deficiency and accumulation syndrome) and its impact on gut microbiota based on 16S rDNA sequencing technology

English Acronym：

Scientific title：

Exploring the clinical efficacy of Feng's Nie-Ji combined with Xiaoji Powder and Huapi Ointment in treating stagnation (spleen deficiency and accumulation syndrome) and its impact on gut microbiota based on 16S rDNA sequencing technology

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

JunWei,Chen

Study leader：

JunWei,Chen

Applicant telephone：

13051153630

Study leader's telephone：

13051153630

Applicant Fax：

Study leader's fax：

Applicant E-mail：

847431304@qq.com

Study leader's E-mail：

847431304@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 23 Meishuguanhou Street Dongcheng District Beijing

Study leader's address：

No. 23 Meishuguanhou Street Dongcheng District Beijing

Applicant postcode：

100010

Study leader's postcode：

100010

Applicant's institution：

Beijing Hospital of Traditional Chinese Medicine Capital Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2024BL02-056-03

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Date of approved by ethic committee：

2024/7/21 0:00:00

Contact Name of the ethic committee：

Sheng,Liu

Contact Address of the ethic committee：

No. 23 Meishuguanhou Street Dongcheng District Beijing

Contact phone of the ethic committee：

010-87906734

Contact email of the ethic committee：

liusheng4377@163.com

Primary sponsor：

Beijing Hospital of Traditional Chinese Medicine Capital Medical University

Primary sponsor's address：

No. 23 Meishuguanhou Street Dongcheng District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Beijing

Institution
hospital：

Beijing Hospital of Traditional Chinese Medicine，Capital Medical University

Address：

No. 23 Meishuguanhou Street, Dongcheng District, Beijing

Source(s) of funding：

Beijing Hospital of Traditional Chinese Medicine Capital Medical University Science and Technology Development Fund（award LYYB202305)

Target disease：

functional dyspepsia

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 clinical efficacy and safety of Feng's Nie-Ji therapy in the treatment of functional dyspepsia in children and provide high-quality evidence-based medicine for the treatment of functional dyspepsia in children with Feng's massage therapy. To explore the biological mechanism of Feng's Nie-Ji therapy in the treatment of functional dyspepsia in children by observing the expression of intestinal microbiota in each group before and after treatment

Description for medicine or protocol of treatment in detail：

Experimental medication: 1.Xiaoji Powder: Nie-Ji Oral Powder a traditional Chinese medicine preparation in medical institutions with registration number Z20190028000. Main ingredients: cooked rhubarb Semen Pharbitidis vinegar rhizoma sparganii vinegar curcuma zedoary and Amomum villosum. 2.Huapi Ointment: Huapi Ointment a traditional Chinese medicine preparation for medical institutions with registration number Z20053399. Main ingredients: rhubarb Chinese angelica tortoise shell hawthorn fruit pit curcuma zedoary frankincense myrrh mirabilite cinnamon musk. The treatment plan: all Nie-Ji operations and medication will be performed by specialized physicians and the procedures and medication usage methods involved in each group will be consistent. (1)Feng's Nie-Ji: Position: children in prone position and the back exposed. For the children who can not cooperate with the independent prone position the parents can sit on the chair and the back is exposed convenient operation. Manual operation: Hold the middle finger ring finger and little finger of both hands in an empty fist shape half bend the index finger extend the thumb and align it with the front half of the index finger starting from the Changqiang acupoint(GV1) under the coccyx of the child (actual operation can start from the coccyx) pinch along the Du meridian to the Dazhui acupoint(GV14). Repeat this cycle pinch six times. When pinching for the fifth time use the technique of "heavily pull" according to the different clinical symptoms of the child and stimulate the acupoints on the back in a targeted manner. After the final kneading massage the Shenshu acupoint several times. (2)Oral Xiaoji Powder: the dosage of Xiaoji Powder for pediatric patients is determined by age and stool condition. (3)External application of Huapi ointment: In order to effectively melt Huapi ointment an electric heating plate is used to heat and melt the ointment for 3 minutes. The Huapi ointment is melted to a brushed shape and at the same time the ointment backing is placed on the back of the hand to test the temperature without burning. The melted Huapi ointment is evenly spread in a blank ointment rubber ring and applied to the Shenque acupoint (RN8) of the child. It is removed the next morning after waking up. Group A: Nie-Ji on an empty stomach 6 times a day (including heavily pull once) for a total of 6 days of treatment. On the morning of the fourth day Xiaoji Powder will be given on an empty stomach. On the fifth day after Nie-Ji Huapi ointment will be applied. On the morning of the sixth day the ointment will be removed. The above treatment lasts for 6 days and 1 day of rest forming one course of treatment for a total of 2 courses of treatment. Group B: Nie-Ji on an empty stomach 6 times a day (including heavily pull once) for a total of 6 days of treatment. On the morning of the fourth day Xiaoji Powder will be given on an empty stomach. The above treatment lasts for 6 days and 1 day of rest forming one course of treatment for a total of 2 courses of treatment. Group C: Nie-Ji on an empty stomach 6 times a day (including heavily pull once) for a total of 6 days of treatment. On the fifth day after Nie-Ji Huapi ointment will be applied. On the morning of the sixth day the ointment will be removed. The above treatment lasts for 6 days and 1 day of rest forming one course of treatment for a total of 2 courses of treatment. Group D: Nie-Ji on an empty stomach 6 times a day (including heavily pull once) for a total of 6 days of treatment. The above treatment lasts for 6 days and 1 day of rest forming one course of treatment for a total of 2 courses of treatment.

Inclusion criteria

(1) Meet the diagnostic criteria of functional dyspepsia in children; (2) Meet the TCM diagnostic criteria for children with accumulated stagnation (spleen deficiency and accumulation syndrome); (3) Age is from 1 to 12 years old with no gender limit; (4) The patient and the guardian can receive treatment and examination.

Exclusion criteria：

(1) The child has been treated with other drugs; (2) Combined with severe primary diseases of heart liver kidney digestive and hematopoietic system; (3) Allergy to the test drug or its ingredients;

Study execute time：

From 2024-05-01

To      2026-05-31

Recruiting time：

From 2024-10-15

To      2026-03-31

Interventions：

36

Group：

A group

Sample size：

Intervention：

Feng's Nie-Ji+Oral Xiaoji Powder+External application of Huapi Ointment

Intervention code：

36

Group：

B group

Sample size：

Intervention：

Feng's Nie-Ji+Oral Xiaoji Powder

Intervention code：

36

Group：

D group

Sample size：

Intervention：

Feng's Nie-Ji

Intervention code：

36

Group：

C group

Sample size：

Intervention：

Feng's Nie-Ji+External application of Huapi Ointment

Intervention code：

Total sample size ： 144

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine，Capital Medical University

Level of the institution：

Grade III A

Outcomes：

Outcome：

effective rate

Type：

Secondary indicator

Measure time point of outcome：

week1 week2 week4

Measure method：

Calculated based on the total score of Traditional Chinese Medicine Syndrome Score

Outcome：

Traditional Chinese Medicine Syndrome Score: Points for Major and Minor Symptoms

Type：

Secondary indicator

Measure time point of outcome：

week0 week1 week2 week4

Measure method：

Traditional Chinese Medicine Syndrome Rating Scale

Outcome：

Intestinal flora

Type：

Secondary indicator

Measure time point of outcome：

week0 week1 week2

Measure method：

stool specimen

Outcome：

Traditional Chinese Medicine Syndrome Score

Type：

Primary indicator

Measure time point of outcome：

week0 week1 week2 week4

Measure method：

Traditional Chinese Medicine Syndrome Rating Scale

Collecting sample(s)
from participants：

Sample Name：

stool specimen

Tissue：

Excluded through the intestine

Fate of sample 

Destruction after use

Note：

Save until 3 months after the end of the study and destroy it uniformly

Not yet recruiting

1
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)：

Generate a random sequence using a random number table and assign it to an independent research assistant using an opaque sealed envelope for concealment. The random envelope is required to be opaque with the inclusion number indicated on the outside of the envelope and grouping information inside. Researchers are required to open the envelope according to the order of patient enrollment and implement interventions on enrolled patients based on the grouping information. 144 children with functional dyspepsia will be randomly assigned to four groups A B C and D in a ratio of 1:1:1:1.

Blinding：

Participants will not be blinded.

IPD sharing：

No

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

Not Applicable

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

This study used a blind evaluation method with a dedicated person who did not know the grouping situation conducting the efficacy evaluation; The data summary stage adopts blind statistical analysis. Implement the separation of researchers evaluators and statisticians. The researchers keep all experimental data including confirmation of all participants (able to effectively verify different records such as hospital records) all original informed consent forms signed by participants all case observation forms etc. The results of this project may be published in medical journals but we will keep the information of the subjects confidential in accordance with legal requirements. Unless required by relevant laws the personal information of the subjects will not be disclosed. When necessary research supervision and management departments hospital ethics committees and their relevant personnel may access patient information in accordance with regulations.

Data Managemen Committee：

No

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

Not Applicable

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