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Liao 16 Efficacy and safety of compound dietary fiber granules in the treatment of functional constipation during pregnancy: a randomized, controlled, multicenter clinical trial

Liao 16 Efficacy and safety of compound dietary fiber granules in the treatment of functional constipation during pregnancy: a randomized, controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059340
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-05-06
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Functional constipation during pregnancy

Interventions

Experimental group: Liao 16 Compound dietary fiber granules + dietary guidance:Liao sixteen Compound dietary fiber granules: 1 bag / time, 3 times a day
Dietary guidance: for example, 500g of vegetables, 200g of fruits and more than 1500ml of drinking water per day, introduce the types of dietary fiber and food types with high dietary fiber, such as a
Control group: dietary guidance:Dietary guidance: for example, 500g of vegetables, 200g of fruits and more than 1500ml of drinking water per day, introduce the types of dietary fiber and food types wi

Sponsors

The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 20 years old (inclusive) to 38 years old (inclusive), female; 2. Meet the diagnostic criteria of constipation in the 2013 Chinese guidelines for the diagnosis and treatment of chronic constipation; 3. This pregnancy is a normal pregnancy; 4. Patients who voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Constipation during pregnancy secondary to other diseases; 2. Complicated with other pregnancy complications; 3. Pregnant women have previous history of inflammatory bowel disease or irritable bowel syndrome; 4. Patients with severe primary diseases such as heart, liver, kidney, digestive and endocrine system, liver and kidney dysfunction (ALT / AST / Cr greater than 1.5 times the upper limit of normal value), and psychiatric patients; 5. Those who are intolerant to the test products and their components; 6. Participated in other clinical trials within 3 months before screening; 7. Other patients that the researcher believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Fecal traits (Bristol fecal traits scale) score;

Secondary

MeasureTime frame
VAS score of defecation effort;Symptom checklist for patients with constipation (PAC-SYM);Quality of life scale (PAC-QOL);

Countries

China

Contacts

Public ContactZou Xuemei

The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine

13969194043@163.com+86 15169097966

Outcome results

None listed

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