NCT00872430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

March 31, 2009

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

November 6, 2008

Results QC Date

November 6, 2008

Last Update Submit

June 16, 2009

Conditions

Chronic Constipation

Keywords

constipationRCTphytotherapy

Outcome Measures

Primary Outcomes (1)

  • Intestinal Transit Time

    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.

    day 3 and day 17

Secondary Outcomes (1)

  • Number of Patients With no Evacuation After Each Intervention Period

    day 5 and day 19

Study Arms (2)

Placebo/Laxative tea crossover

ACTIVE COMPARATOR

This arm received placebo in the first period and laxative tea in the second period (after washout period of 9 days).

Other: PlaceboOther: Klein Laxative Tea

Laxative tea/Placebo crossover

ACTIVE COMPARATOR

This arm received laxative tea in the first intervention period and placebo in the second intervention period (after washout period of 9 days).

Other: PlaceboOther: Klein Laxative Tea

Interventions

PlaceboOTHER

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.

Laxative tea/Placebo crossoverPlacebo/Laxative tea crossover
Klein Laxative TeaOTHER

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.

Also known as: Phytotherapeutic tea, laxative tea
Laxative tea/Placebo crossoverPlacebo/Laxative tea crossover

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant or breast feeding women;
  • patients with history of abuse of alcohol or use of drugs;
  • significant or not-controlled disease, except constipation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (1)

  • Picon PD, Picon RV, Costa AF, Sander GB, Amaral KM, Aboy AL, Henriques AT. Randomized clinical trial of a phytotherapic compound containing Pimpinella anisum, Foeniculum vulgare, Sambucus nigra, and Cassia augustifolia for chronic constipation. BMC Complement Altern Med. 2010 Apr 30;10:17. doi: 10.1186/1472-6882-10-17.

    PMID: 20433751DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Paulo Dornelles Picon
Organization
Hospital de Clínicas de Porto Alegre
paulopicon@gmail.com
55 xx 51 21018752

Study Officials

  • Paulo D picon, Coordinator

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2008

First Posted

March 31, 2009

Study Start

July 1, 2002

Primary Completion

December 1, 2002

Study Completion

June 1, 2003

Last Updated

June 17, 2009

Results First Posted

March 31, 2009

Record last verified: 2009-06

Locations

BR(1)