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Observation on the Efficacy of Xiao Chengqi Decoction with Modifications Combined with Lactulose in the Treatment of Pediatric Constipation (Spleen-Stomach Heat Accumulation Type)

Clinical Observation on the Combined Therapy of Tuina and Herbal Foot Bath for Real Syndrome Constipation in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000019
Enrollment
Unknown
Registered
2026-01-04
Start date
2021-09-30
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Constipation

Interventions

Observation group:Lactulose combined with Xiaochengqi Decoction adjusted therapy.
Control Group:Lactulose Treatment

Sponsors

Hebei Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Children must meet the Western medicine diagnostic criteria in the "Expert Consensus on the Diagnosis and Treatment of Functional Constipation in Children with Integrated Traditional Chinese and Western Medicine", and the TCM syndrome differentiation criteria for spleen and stomach heat accumulation in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine"; be aged 4-10 years, regardless of gender; have not received any systemic treatment for constipation within one month prior to enrollment; and have received informed consent from their guardians, who must have signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with other gastrointestinal diseases; (2) Patients with secondary constipation caused by other diseases; (3) Patients with severe dysfunction of important organs such as heart, liver, or kidneys; (4) Patients allergic to the drugs used in the study; (5) Patients participating in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
Overall clinical efficacy rate;

Secondary

MeasureTime frame
Constipation Symptom Scoring;traditional Chinese medicine Syndrome Score;Laboratory indicators;Adverse Event Incidence Rate;

Countries

China

Contacts

Public ContactWang Qingqing

Hebei Provincial Traditional Chinese Medicine Hospital

wangqingqqqw@163.com13832776422

Outcome results

None listed

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