Trial Outcomes & Findings for Laxative Effectiveness of a Phytotherapeutic Tea (NCT NCT00872430)
NCT ID: NCT00872430
Last Updated: 2009-06-17
Results Overview
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.
COMPLETED
PHASE2
20 participants
day 3 and day 17
2009-06-17
Participant Flow
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.
Twenty patients fulfilled elegibility criteria. No patients were excluded after signing informed consent form and randomization.
Participant milestones
| Measure |
Placebo First Crossover
Placebo in the first period and laxative tea in the second period (after washout period)
|
Laxative Tea First Crossover
Laxative tea in the first period and placebo in the second period (after washout period).
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
10
|
10
|
|
Washout Period
COMPLETED
|
10
|
10
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laxative Effectiveness of a Phytotherapeutic Tea
Baseline characteristics by cohort
| Measure |
Placebo First Crossover
n=10 Participants
Placebo in the first period and laxative tea in the second period (after washout period)
|
Laxative Tea First Crossover
n=10 Participants
Laxative tea in the first period and placebo in the second period (after washout period).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 3 and day 17Radiologic 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.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo administered three times a day in either first intervention period or second intervention period.
|
Laxative Tea
n=20 Participants
Laxative tea administered three times a day in either first intervention period or second intervention period.
|
|---|---|---|
|
Intestinal Transit Time
|
42.3 hours
Standard Deviation 18.86
|
15.66 hours
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: day 5 and day 19The 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).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo administered three times a day in either first intervention period or second intervention period.
|
Laxative Tea
n=20 Participants
Laxative tea administered three times a day in either first intervention period or second intervention period.
|
|---|---|---|
|
Number of Patients With no Evacuation After Each Intervention Period
|
9 participants
|
0 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paulo Dornelles Picon
Hospital de Clínicas de Porto Alegre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place