ITMCTR2000004131
Not Yet Recruiting
Phase 1
Study on the Clinical markers of children with constipation and the Therapeutic Effect of Xiaoji Tongbian Prescription on internal heat syndrome of constipation
Affiliated Hospital of Nanjing University of Chinese Medicine0 sitesTBD
ConditionsConspitation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Conspitation
- Sponsor
- Affiliated Hospital of Nanjing University of Chinese Medicine
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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;
Outcomes
Primary Outcomes
Not specified
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