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

Solvay

Status and phase: Terminated; Phase 4

Conditions: Anal Fissures; Hemorrhoids

Treatments: Drug: Plantago ovata; Drug: Lactulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160290

S105.4.106

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

A

Experimental group

Description:

Lactulose Group

Treatment:

Drug: Lactulose

B

Active Comparator group

Description:

Plantago Group

Treatment:

Drug: Plantago ovata