PainNCT03414099
Ketum and Pain Tolerence
A study testing Ketum in people with Pain, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Ketum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Jan 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months.
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Exclusion Criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing.
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Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Centre for Drug Research, Univerisiti Sains Malaysia
George Town, Pulau Pinang, 11800
Vicknasingam Kasinather, PhD, 604653272, vickna@usm.my
Vicknasingam Kasinather, PhD
About this study
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.
Read the detailed description
Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.
- Conditions
- Pain
- Being tested
- Ketum, Placebo
- Keywords
- Pain, Kratom, Ketum, mitragynine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetumDrug
Also called Kratom
Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture
PlaceboDrug
Placebo drink matched for taste and appereance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance
The duration (seconds) participants can keep their hands immersed in the water bath
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start23 Jan 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, repeated measures
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Vicknasingam B Kasinather, Universiti Sains Malaysia
- Investigators
- Vicknasingam Kasinather, PhD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414099
- Sponsor's protocol ID
- USM/JEPeM/17050243
- Status last verified
- Apr 2021
- First submitted
- 22 Jan 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketum and Pain Tolerence
- ClinicalTrials.gov ID
- NCT03414099
- Acronym / sponsor ID
- USM/JEPeM/17050243
- Conditions
- Pain
- Keywords
- Pain, Kratom, Ketum, mitragynine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.
Detailed description
Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject, repeated measures
| Arm | Type | Receives |
|---|---|---|
| Ketum | Experimental | Drug: KetumEach 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. |
| Placebo | Placebo comparator | Drug: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetumAlso: KratomKetum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture | Drug | Ketum |
| PlaceboPlacebo drink matched for taste and appereance | Drug | Placebo |
Primary outcome
Pain tolerance
Time frame: 3 hours
The duration (seconds) participants can keep their hands immersed in the water bath
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicknasingam Kasinather, PhD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketum in people with Pain, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohd Bazlan Hafidz Mukrim, BSc (609-7672354 ext. 2362, bazlan@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain tolerance (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.