Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovate on the Quality of Life of Patients With Hard Stools and Hemorrhoids or Anal Fissure

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160290

Enrollment

Registered

2005-09-12

Start date

2002-03-31

Completion date

2006-06-30

Last updated

2008-05-06

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

Conditions

Anal Fissures, Hemorrhoids

Keywords

lactulose, randomised clinical trial, hemorrhoids, anal fissures

Brief summary

To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.

Interventions

DRUGLactulose

15 mL / 12 hours

DRUGPlantago ovata

3,5 g / 12 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.

Exclusion criteria

* Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

Design outcomes

Primary

Measure	Time frame
Quality of life of patients with hard stools and hemorrhoids or anal fissure	6 weeks

Secondary

Measure	Time frame
Gastrointestinal Symptoms Rating Scale	6 weeks
Bristol stool consistency scale	6 weeks
Number of episodes of rectal bleeding	6 weeks
Need of rescue medication	6 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026