Laxative Effectiveness of a Phytotherapeutic Tea

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00872430
• Collaborator: Federal University of Rio Grande do Sul (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Laboratório Klein Ltda. (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with chronic constipation.

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Other: Placebo; Other: Klein Laxative Tea	Phase 2

Detailed Description

The Klein Laxative Tea is a pharmaceutical phytotherapeutic product that's been used for several years in Brazil for the treatment of constipation. This product contains fruit of Pimpinella anisum (green anises), fruit of Foeniculum vulgare (fennel), flowers of Sambucus nigra (elder tree) and flowers of Cassia angustifolia (senna). In spite of the beneficial effects of its components, separately demonstrated in vitro, it never had its effectiveness appraised in a randomized clinical trial.The purpose of this study was to evaluate the efficacy and safety of this product in a randomized crossover placebo-controlled clinical trial. Twenty patients presenting with the criteria of the American Association of Gastroenterology for chronic constipation were included, and concluded a two-phase crossover study. The primary endpoint was the evaluation of the intestinal transit time measured through radiological technique. The secondary endpoints were the number of evacuations, subjective impression of the quality in the intestinal habit, quality of life appraised through WHOQOL-brief and adverse effects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Laxative Effectiveness of a Phytotherapeutic Tea: A Randomized Placebo-Controlled Clinical Trial
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Dec 1, 2002
• Actual Study Completion Date: Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Placebo/Laxative tea crossover This arm received placebo in the first period and laxative tea in the second period (after washout period of 9 days).	Other: Placebo; In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.; Other: Klein Laxative Tea; The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.; Other Names: Phytotherapeutic tea laxative tea
Active Comparator: Laxative tea/Placebo crossover This arm received laxative tea in the first intervention period and placebo in the second intervention period (after washout period of 9 days).	Other: Placebo; In order to produce similar taste and color, 7 drops of caramel color and 10 drops of orange essence were mixed into 1.6 liters of boiling water. The patients received 150 ml of placebo 3 times a day for 5 days.; Other: Klein Laxative Tea; The laxative tea was prepared using 1 gram of grinded plant into 150 ml of water, left under infusion by 5 minutes. Patients received 150 ml of tea 3 times a day for 5 days.; Other Names: Phytotherapeutic tea laxative tea

Outcome Measures

Primary Outcome Measures

1. Intestinal Transit Time [day 3 and day 17]

   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.

Secondary Outcome Measures

1. Number of Patients With no Evacuation After Each Intervention Period [day 5 and day 19]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• patients with 18 to 55 years old with chronic constipation according to the criteria of the American Association of Gastroenterology (AAG);

• patients should present good understanding and collaboration capacity, an not be in use of other medications with effects on the intestinal habit;

• patients with no abnormalities in the exams;

• willing to sign a written informed consent;

• women in fertile age should make use of appropriate anti-conception.

Exclusion Criteria:

• pregnant or breast feeding women;

• patients with history of abuse of alcohol or use of drugs;

• significant or not-controlled disease, except constipation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Brazil	90035903

Sponsors and Collaborators

• Hospital de Clinicas de Porto Alegre
• Federal University of Rio Grande do Sul
• Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Laboratório Klein Ltda.

Investigators

• Principal Investigator: Paulo D picon, Coordinator, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00872430
• Other Study ID Numbers: 02121
• First Posted: Mar 31, 2009
• Last Update Posted: Jun 17, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: constipation; RCT; phytotherapy
• Additional relevant MeSH terms: Constipation; Laxatives; Cathartics

Study Results

Participant Flow

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 Detail	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
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: First Intervention
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo First Crossover	Laxative Tea First Crossover	Total
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 Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 90%	10 100%	19 95%
Male	1 10%	0 0%	1 5%
Region of Enrollment (participants) [Number]
Brazil	10 100%	10 100%	20 100%

Outcome Measures

1. Secondary Outcome

Title	Number of Patients With no Evacuation After Each Intervention Period
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Laxative Tea
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.
Measure Participants	20	20
Number [participants]	9 90%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Laxative Tea
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Intestinal Transit Time
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Laxative Tea
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.
Measure Participants	20	20
Mean (Standard Deviation) [hours]	42.3 (18.86)	15.66 (9.71)

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.