NCT05416697CompletedPhase 3
Effectiveness of Cannabinoids on Appetite in Scleroderma
Effectiveness of Cannabinoid on Appetite, Sleep Quality, Quality of Life, Joint Pain, and Cytokine Level in Systemic Sclerosis Patients: a Randomized Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The cannabinoid has benefits in many aspects but the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and critical cytokine level in SSc compared with placebo in SSc patients and the adverse events associated with cannabinoids in those patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 9 Jun 2022
- Start date
- 9 Nov 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Khon Kaen University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05416697
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 30
- From 9 Nov 2022 to the primary completion date, 31 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allergy to cannabinoid or their derivatives
- Concomitant illegal drug used (amphetamine or its derivative, cocaine)
- History of the previous cannabinoid using or concomitant any herbal included cannabinoid used
- Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders
- Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin
Other illness
- Overlap with other connective tissue diseases
- Evidence of active malignant disease
- Present active infection that needs systemic antibiotic
- Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease)
- Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease
Lab values
- Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr\>1.4 mg/dl)
Other
- Pregnancy or lactation
- Bedridden and confined to no self-care
- On-going anxiolytics, hypnotics, or sleeping pills used
- In a period that needs immunosuppressant dose adjustment
Who the study is looking for
- SSc patients aged between 18 and 70 years
- Diagnosed according to ACR/EULAR 2013 classification criteria
- Having anorexia or malnutrition status
- Must not receive steroid equivalent to prednisolone dose more than 10 mg/d
- Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment
- Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment
- Understand and able to read and write the Thai language
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Medicine, Faculty of Medicine, Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Scleroderma Clinic, Faculty of Medicine, Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
Related publications
- Efficacy of cannabis oil on appetite and quality of life in systemic sclerosis patients: a randomized placebo-controlled trial.J Cannabis Res · 2025 · PMID 41137182
This page is information, not medical advice. Discuss any trial with your doctor.