Study on the Clinical markers of children with constipation and the Therapeutic Effect of Xiaoji Tongbian Prescription on internal heat syndrome of constipatio

Phase 1

• Conditions: Conspitation

• Registration Number: ITMCTR2000004131
• Lead Sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnostic criteria of Western medicine
With reference to the Roman IV constipation diagnosis standards (2016 edition) and ZhuFuTang practical pediatrics relevant content:
Infants under 4 years of age must include at least 2 of the following items within 1 month:
(1) The frequency of defecation is 2 times or less per week.
(2) History of excessive fecal retention.
(3) A history of painful defecation or hard excrement.
(4) A history of heavy excrement.
(5) There is a large fecal mass in the rectum.
For children learning to use the toilet, the following additional criteria may be applied:
(6) Having fecal incontinence at least once a week after learning to defecate in the toilet.
(7) Having a history of heavy excrement, which may even cause a blockage of the toilet.
Diagnostic criteria for functional constipation in children and adolescents: must include two or more items, symptoms appear at least once a week for at least one month, and do not meet the diagnostic criteria for irritable bowel syndrome:
(1) For children aged at least 4 years, the frequency of defecation is 2 times a week or less.
(2) Fecal incontinence at least once a week.
(3) A history of fecal retention in a passive position or excessive fecal retention.
(4) A history of painful defecation or hard excretion of feces.
(5) There is a large fecal mass in the rectum.
(6) Having a history of heavy excrement, which may even cause a blockage of the toilet.
(7) After a moderate assessment, symptoms cannot be fully explained by other manifestations of the disease.
Summary: 1) days of defecation interval > 2d, defecation times < 3 times/w without laxative;2) Dry and hard stools and/or difficulty in defecating;3) Duration =1 month.Children should have all three of the above.
Diagnostic criteria of constipation in Traditional Chinese medicine:
According to the Chinese Medicine Pediatrics and Chinese Medicine Internal Disease Syndrome Diagnosis and Curative Effect Standard :
(1) The interval time of defecation is extended, two days to once, the stool is dry or tight, the heavy stool is difficult, the fecal material is dry like chestnut;
(2) frequent, but difficult to discharge or discharge;
(3) May be accompanied by abdominal distension, abdominal pain, loss of appetite or vomiting, irritability, restless night sleep, crying at night, growth retardation and other diseases.
(4) Elimination of organic intestinal diseases.
Children should have at least item (1).
Criteria for diagnosis of internal heat syndrome of constipation in Chinese medicine:
According to the Chinese Medicine Pediatrics and Chinese Medicine Internal Disease Syndrome Diagnosis and Curative Effect Standard :
(1) Stool dry, discharge difficulty.
(2) Red or red purple tongue, thin yellow or yellow greasy or thick greasy ancient moss.
(3) The pulse is solid or slippery, or fingerprint purple stagnation.
(4) Hot face, warm hands and feet, red lips and bad breath.
(5) Accompanied by abdominal distension or abdominal pain, restless night.
(6) Loss of appetite, lack of milk, or nausea and vomiting.
(7) Urinate yellow.
Treatment group inclusion criteria
(1) For those who meet the above diagnostic criteria of Western medicine, the treatment group shall meet the criteria of disease differentiation and syndrome differentiation of Traditional Chinese medicine;
(2) Between the ages of 1 and 12, regardless of gender;
(3) No relevant medication was used during the illness;
(4) Inform

Exclusion Criteria

(1) Do not meet the inclusion criteria for cases.
(2) Constipation is caused by organic intestinal diseases (such as megacolon, sigmoid syndrome, rectal stricture), endocrine diseases, metabolic diseases, and neurological diseases.
(3) Combined with cardiovascular and cerebrovascular, liver and kidney, hematopoietic system and other primary diseases and neuropsychiatric diseases;
(4) The efficacy cannot be determined due to incomplete data, failure to take medication as prescribed or interruption of treatment without authorization;
(5) Allergic to the traditional Chinese medicine ingredients;
(6) age < 1 and age > 12;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stool property;Defecation frequency;