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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004859
Enrollment
Unknown
Registered
2021-05-16
Start date
2021-12-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation in Children

Interventions

Sponsors

School of Second Clinical Medicine, Yunnan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Spontaneous Bowel Movements (SBMs);Stool morphology score;Completed Spontaneous Bowel Movements (SBMs);

Secondary

MeasureTime frame
Frequency of use of glycerine enema;Defecation difficulty score;

Countries

China

Contacts

Public ContactZhang Xinghe

Yunnan University of Chinese Medicine

doczhangxh@163.com+86 18487321975

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026