NCT03414099

Brief Summary

The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 22, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3.9 years

First QC Date

January 22, 2018

Last Update Submit

April 26, 2021

Conditions

Pain

Keywords

PainKratomKetummitragynine

Outcome Measures

Primary Outcomes (1)

  • Pain tolerance

    The duration (seconds) participants can keep their hands immersed in the water bath

    3 hours

Study Arms (2)

Ketum

EXPERIMENTAL

Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.

Drug: Ketum

Placebo

PLACEBO COMPARATOR

Each participant will consume a sequence of active ketum or placebo drinks. Pain tolerance will be measured using the cold pressor task after consuming each drink.

Drug: Placebo

Interventions

KetumDRUG

Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture

Also known as: Kratom
Ketum
PlaceboDRUG

Placebo drink matched for taste and appereance

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Drug Research, Univerisiti Sains Malaysia

George Town, Pulau Pinang, 11800, Malaysia

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

mitragynine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vicknasingam Kasinather, PhD

    Director

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Bazlan Hafidz Mukrim, BSc

CONTACT

609-7672354bazlan@usm.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Ketum and placebo drinks will be matched for taste and appearence. Each study participant will receive a sequence of ketum and placebo drinks in random order.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Within-subject, repeated measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

January 23, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)