Status:
COMPLETED
Effectiveness of Cannabinoids on Appetite in Scleroderma
Lead Sponsor:
Khon Kaen University
Conditions:
Systemic Sclerosis
Malnutrition
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Systemic sclerosis (SSc) is a connective tissue disease for which skin tightness is the hallmark. The disease is classified into 2 major subsets: limited cutaneous systemic sclerosis (lcSSc) and diffu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Overlap with other connective tissue diseases
- Pregnancy or lactation
- Bedridden and confined to no self-care
- Evidence of active malignant disease
- Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr\>1.4 mg/dl)
- Present active infection that needs systemic antibiotic
- 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
- On-going anxiolytics, hypnotics, or sleeping pills used
- In a period that needs immunosuppressant dose adjustment
- 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
- 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
Key Trial Info
Start Date :
November 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05416697
Start Date
November 9 2022
End Date
December 31 2024
Last Update
February 20 2025
Active Locations (2)
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1
Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
2
Scleroderma Clinic, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002