Uremic PruritusPhase 1/2NCT06159686
The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus
A Phase 1/2 study testing Hemp in people with Uremic Pruritus, run by Thammasat University Hospital at 1 site in Thailand.
Trial summary
Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Hemp
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 15 Sep 2023to 8 Dec 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old, diagnosed with end-stage kidney disease
- Undergoing thrice-weekly chronic hemodialysis for more than 90 days
- Exhibit a WI-NRS score of 3 or higher
Who cannot join
- Ahistory of hemp allergy
- Pregnancy or breastfeeding
- Dermatologic diseases
- Adjustments to medications for controlling itch within the 14 days preceding the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients. Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2, 4.
Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms.
This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.
Read the detailed description
Eligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant.
We planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also is validated with second assistant.
For statistical analysis, continuous variables are compared using an unpaired t-test or Mann-Whitney U test, as appropriate. Categorical variables are compared using a Chi-square test or Fisher's exact test. The adjusted mean difference is used Analysis of Covariance (ANCOVA) , adjusted by score at baseline.
All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).
- Conditions
- Uremic Pruritus
- Being tested
- Hemp, Placebo
- Keywords
- Hemp, Uremic pruritus, hemodialysis, cannabinoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HempDrug
The application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
PlaceboDrug
The application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| hemp group | Experimental | They was assigned to apply the hemp-containing cream. Receives: Drug: Hemp |
| Control group | Placebo comparator | They was assigned to apply the placebo cream. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WI-NRS (Worst Itching Numerical Rating scale) score at week 4
WI-NRS score will demonstrate the severity of itch at week 4. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome.
Measured: week 4
Secondary outcomes (3)
WI-NRS at week 2
WI-NRS score will demonstrate the severity of itch at week 2. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome.
Measured: week 2
Skindex-10 score at weeks 2 and 4
Skindex-10 score will demonstrate the itch-related quality of life at week 2 and 4. The minimum score is 10 and maximum score is 60. The higher scores mean a worse outcome.
Measured: week 2 and 4
the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score
The change of WI-NRS score and Skindex-10 score between baseline and week 4 represents the change of severity and QOL after complete study (week4) compare to baseline. The greater different scores mean a better outcome.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start15 Sep 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uremic PruritusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthiya Anumas, Thammasat University Hospital
- Investigators
- Suthiya Anumas, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159686
- Sponsor's protocol ID
- 074/2566
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anumas S, Kuropakornpong P, Chakkavittumrong P, Tasanarong A, Pattharanitima P. Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial. Kidney Med. 2024 Aug 21;6(10):100894. doi: 10.1016/j.xkme.2024.100894. eCollection 2024 Oct.
PubMed 39328960
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients. Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2, 4.
- ClinicalTrials.gov ID
- NCT06159686
- Acronym / sponsor ID
- 074/2566
- Conditions
- Uremic Pruritus
- Keywords
- Hemp, Uremic pruritus, hemodialysis, cannabinoid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 7 Dec 2023 (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.
Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms.
This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.
Detailed description
Eligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant.
We planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also is validated with second assistant.
For statistical analysis, continuous variables are compared using an unpaired t-test or Mann-Whitney U test, as appropriate. Categorical variables are compared using a Chi-square test or Fisher's exact test. The adjusted mean difference is used Analysis of Covariance (ANCOVA) , adjusted by score at baseline.
All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemp group | Experimental | Drug: HempThey was assigned to apply the hemp-containing cream. |
| Control group | Placebo comparator | Drug: PlaceboThey was assigned to apply the placebo cream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 years old, diagnosed with end-stage kidney disease
- Undergoing thrice-weekly chronic hemodialysis for more than 90 days
- Exhibit a WI-NRS score of 3 or higher
Key exclusion criteria (4 listed)
- Ahistory of hemp allergy
- Pregnancy or breastfeeding
- Dermatologic diseases
- Adjustments to medications for controlling itch within the 14 days preceding the study.
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 |
|---|---|---|
| HempThe application of the hemp-containing cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks. | Drug | hemp group |
| PlaceboThe application of the placebo cream occurred in the morning and evening on the itching areas, excluding the face for 4 weeks. | Drug | Control group |
Primary outcome
WI-NRS (Worst Itching Numerical Rating scale) score at week 4
Time frame: week 4
WI-NRS score will demonstrate the severity of itch at week 4. The minimum score is 0 and maximum score is 10. The higher scores mean a worse outcome.
3 secondary outcomes
WI-NRS at week 2
Time frame: week 2
Skindex-10 score at weeks 2 and 4
Time frame: week 2 and 4
the mean difference score between baseline and week 4 for WI-NRS and the Skindex-10 score
Time frame: week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 39328960Anumas S, Kuropakornpong P, Chakkavittumrong P, Tasanarong A, Pattharanitima P. Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial. Kidney Med. 2024 Aug 21;6(10):100894. doi: 10.1016/j.xkme.2024.100894. eCollection 2024 Oct.
- Individual participant dataSharing planned: No
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.
Suthiya Anumas principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hemp in people with Uremic Pruritus, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 27 Mar 2024. 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 Thailand. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WI-NRS (Worst Itching Numerical Rating scale) score at week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159686, which also lists 1 linked publication.
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 27 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.