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

S

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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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