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Study on the Treatment effect and Dose-effect Relationship of Sun's Yiqi Jianpi Tongbian Formula Granules in treating functional constipation in pediatric patients

Study on the Treatment effect and Dose-effect Relationship of Sun's Yiqi Jianpi Tongbian Formula Granules in treating functional constipation in pediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099040
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-24

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

Control group:On the basis of basic treatment, lactulose oral solution is taken, the main ingredient of which is lactulose, the specification is 100ml: 66.7g). Manufacturer: Beijing Hanmi Pharmaceutic
Children aged 7-14 years should start with 10-15 ml and maintain 10-15 ml.
Standard dose group:On the basis of basic treatment, the standard dose group formula granules were taken, and the drug composition was Atractylodes macrocephalus, Pseudostellaria pseudostellaria, Ange
Children 7-14 years old take 1 sachet each time.
Reduced dose group:On the basis of basic treatment, the formula granules of the reduced group were taken, and the drug composition was Atractylodes macrocephalus, Pseudostellaria radix, Angelica sinen

Sponsors

Beijing Hepingli Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: Western medical diagnostic criteria: according to the Rome IV criteria, meet at least 2 of the following conditions, and occur at least once a week for at least 1 month: 1. No more than 2 bowel movements in the toilet per week, 2. Fecal incontinence at least once a week, 3. A history of fecal retention posture or excessive restraint of defecation, 4. A history of painful defecation or straining to defecate, 5. Large fecal masses in the rectum, 6. Coarse fecal masses that have blocked the toilet. 1. Meet the above Western medical diagnostic standards, and meet the TCM syndrome differentiation standards for spleen deficiency and intestinal dryness. 2. Those aged 4-14 years old and able to cooperate with taking drugs 3. Sign the informed consent form and volunteer to take the test

Exclusion criteria

Exclusion criteria: 1. History of gastrointestinal organic diseases or other major diseases 2. Persons > 14 years old or < 4 years old 3. Irritable bowel syndrome or constipation caused by medications

Design outcomes

Primary

MeasureTime frame
Total number of spontaneous defecation;

Secondary

MeasureTime frame
Quality of life scale score for patients with constipation;Bristol Stool Trait Scale score;Constipation Assessment Scale score;Constipation scoring system;Wexner constipation scoring system;Wexner rating;Blood routine test;Urine routine test;Shit routine test;

Countries

China

Contacts

Public ContactYingke Liu

Beijing Hepingli Hospital

liuyun0802@163.com+86 134 2640 2152

Outcome results

None listed

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