|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
TCTR |
|
Last refreshed on:
|
29 April 2024 |
|
Main ID: |
TCTR20140908001 |
|
Date of registration:
|
08/09/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetics of Kratom in Man
|
|
Scientific title:
|
Pharmacokinetics of Kratom in Man |
|
Date of first enrolment:
|
06/07/2013 |
|
Target sample size:
|
|
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
https://www.thaiclinicaltrials.org/show/TCTR20140908001 |
|
Study type:
|
Interventional |
|
Study design:
|
N/A
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Contacts
|
|
Name:
|
Satariya
Trakulsrichai |
|
Address:
|
270 Rama VI Road, Ratchathewi
10400
Bangkok
Thailand |
|
Telephone:
|
+66-8-5-0470101 |
|
Email:
|
satariya.tra@mahidol.ac.th |
|
Affiliation:
|
Faculty of Medicine Ramathibodi Hospital, Mahidol University |
|
|
Name:
|
Satariya
Trakulsrichai |
|
Address:
|
270 Rama VI Road, Ratchathewi
10400
Bangkok
Thailand |
|
Telephone:
|
+66-8-5-0470101 |
|
Email:
|
satariya.tra@mahidol.ac.th |
|
Affiliation:
|
Faculty of Medicine Ramathibodi Hospital, Mahidol University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: The participants who had no underlying diseases, use Kratom regularly more than 6 months, had the positive urine or blood for mitragynine at the 1st hospital visit.
Exclusion criteria: The participants denied to participate in the study
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic users
|
|
Intervention(s)
|
|
Eating Kratom
|
|
Experimental Other
|
|
Kratom
|
|
Primary Outcome(s)
|
|
Pharmacokinetics 1 October 2014 Pharmacokinetic parameter, Clinical trial Phase I
|
|
Secondary Outcome(s)
|
|
pain 24 hours after intervention numeric pain score,Cost 24 hours after intervention total cost of pain control
|
|
Secondary ID(s)
|
|
Nil Known
|
|
Source(s) of Monetary Support
|
|
Faculty of Medicine Ramathibodi Hospital, Mahidol University
|
|
Ethics review
|
Status: Submitted, approved
Approval date:
Contact:
Committee on Human Rights Related to Research Invovling Human Subjects
+66-2-354-7275 Ext.
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
26/10/2013 |
|
URL:
|
|
|
|