Effectiveness of Cannabinoids on Appetite in Scleroderma
NCT05416697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-02-20
Summary
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.
Conditions
- Systemic Sclerosis
- Malnutrition
- Loss of Appetite
Interventions
- DRUG
-
CBD oil
The subjects will receive cannabis 2.7 mg THC 2.5 mg CBD twice daily (1 droplet twice daily; 0.73 mg THC and 0.81 mg CBD/drop, 1.46 mg THC and 1.62 CBD/day) for 1 week then titrate up to 2 droplets twice daily if tolerated (2.92 mg THC and 3.24 CBD per day) and continue the treatment until the end of the study.
- DRUG
-
The subjects will receive 1 droplet of placebo twice daily then titrate up to 2 droplets twice daily if tolerated and continue the treatment until the end of the study.
Sponsors & Collaborators
-
Khon Kaen University
lead OTHER
Principal Investigators
-
Chingching Foocharoen, M.D. · Khon Kaen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-09
- Primary Completion
- 2024-10-31
- Completion
- 2024-12-31
Countries
- Thailand
Study Locations
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