Pediatric Tuina for functional constipation in children: a randomized controlled clinical trail

Phase 1

• Conditions: Functional Constipation in Children

• Registration Number: ITMCTR2100004859
• Lead Sponsor: School of Second Clinical Medicine, Yunnan 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

1. Children aged 1-7 years;
2. Children who meet the diagnostic criteria for functional constipation (Rome IV);
(1) Must include 1 month of at least 2 of the following in infants up to 4 years of age:
1) 2 or fewer defecations per week;
2) History of excessive stool retention;
3) History of painful or hard bowel movements;
4) History of large-diameter stools;
5) Presence of a large fecal mass in the rectum. In toilet-trained children, the following additional criteria may be used:
6) At least 1 episode/week of incontinence after the acquisition of toileting skills;
7) History of large-diameter stools that may obstruct the toilet.
(2) For children over 4 years of age, there must include 2 or more of the following occurring at least once per week for a minimum of 1 month with insufficient criteria for a diagnosis of irritable bowel syndrome:
1) 2 or fewer defecations in the toilet per week in a child of a developmental age of at least 4 years;
2) At least 1 episode of fecal incontinence per week;
3) History of retentive posturing or excessive volitional stool retention;
4) History of painful or hard bowel movements;
5) Presence of a large fecal mass in the rectum;
6) History of large diameter stools that can obstruct the toilet;
3. Parents or legal guardians are motivated to participate in the trial;
4. Parents or legal guardians' sign was written informed consent.

Exclusion Criteria

1. A history of intestinal surgery;
2. Receiving gastrointestinal prokinetic agent or laxative treatments 14 days before enrollment;
3. Receiving pediatric Tuina or probiotics 14 days before enrollment;
4. Children with Hirschsprung's disease;
5. Children with neurological and psychiatric disorders (e.g., cerebral palsy, autism, spina bifida, anorexia nervosa);
6. Children with any organic or metabolic diseases of hematopoietic, endocrine, immune systems.

Study & Design

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