Chronic Constipation
Conditions
Keywords
constipation, RCT, phytotherapy
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.
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.
Interventions
OTHERPlacebo
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.
OTHERKlein 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.
Sponsors
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Laboratório Klein Ltda.
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Brazil
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 details
Twenty patients fulfilled elegibility criteria. No patients were excluded after signing informed consent form and randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo First Crossover Placebo in the first period and laxative tea in the second period (after washout period) | 10 |
| Laxative Tea First Crossover Laxative tea in the first period and placebo in the second period (after washout period). | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo First Crossover | Laxative Tea First Crossover | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment Brazil | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Outcome results
Primary
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.
Time frame: day 3 and day 17
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Intestinal Transit Time | 42.3 hours | Standard Deviation 18.86 |
| Laxative Tea | Intestinal Transit Time | 15.66 hours | Standard Deviation 9.71 |
Comparison: 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.p-value: <0.001t-test, 2 sided
Secondary
Number of Patients With no Evacuation After Each Intervention Period
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients With no Evacuation After Each Intervention Period | 9 participants |
| Laxative Tea | Number of Patients With no Evacuation After Each Intervention Period | 0 participants |
p-value: <0.001t-test, 2 sided