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Laxative Effectiveness of a Phytotherapeutic Tea

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ClinicalTrials.gov Identifier: NCT00872430
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : March 31, 2009
Last Update Posted : June 17, 2009
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Laboratório Klein Ltda.
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Chronic Constipation
Interventions Other: Placebo
Other: Klein Laxative Tea
Enrollment 20
Recruitment Details Patients recruited by the Clinical Research Unit from output clinic at Hospital de Clínicas de Porto Alegre through written announcements attached to panels inside the institution.
Pre-assignment Details Twenty patients fulfilled elegibility criteria. No patients were excluded after signing informed consent form and randomization.
Arm/Group Title Placebo First Crossover Laxative Tea First Crossover
Hide Arm/Group Description Placebo in the first period and laxative tea in the second period (after washout period) Laxative tea in the first period and placebo in the second period (after washout period).
Period Title: First Intervention
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Washout Period
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Placebo First Crossover Laxative Tea First Crossover Total
Hide Arm/Group Description Placebo in the first period and laxative tea in the second period (after washout period) Laxative tea in the first period and placebo in the second period (after washout period). Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
9
  90.0%
10
 100.0%
19
  95.0%
Male
1
  10.0%
0
   0.0%
1
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Intestinal Transit Time
Hide Description Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time.
Time Frame day 3 and day 17
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Laxative Tea
Hide Arm/Group Description:
Placebo administered three times a day in either first intervention period or second intervention period.
Laxative tea administered three times a day in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: hours
42.3  (18.86) 15.66  (9.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Laxative Tea
Comments All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With no Evacuation After Each Intervention Period
Hide Description The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent).
Time Frame day 5 and day 19
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Laxative Tea
Hide Arm/Group Description:
Placebo administered three times a day in either first intervention period or second intervention period.
Laxative tea administered three times a day in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
9 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Laxative Tea
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paulo Dornelles Picon
Organization: Hospital de Clínicas de Porto Alegre
Phone: 55 xx 51 21018752
Responsible Party: Paulo Dornelles Picon, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00872430     History of Changes
Other Study ID Numbers: 02121
First Submitted: November 6, 2008
First Posted: March 31, 2009
Results First Submitted: November 6, 2008
Results First Posted: March 31, 2009
Last Update Posted: June 17, 2009