Malnutrition Clinical Trial
Official title:
Effectiveness of Cannabinoid on Appetite, Sleep Quality, Quality of Life, Joint Pain, and Cytokine Level in Systemic Sclerosis Patients: a Randomized Placebo-controlled Trial
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 | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. SSc patients aged between 18 and 65 years 2. Diagnosed according to ACR/EULAR 2013 classification criteria 3. Having anorexia or malnutrition status 4. Must not receive steroid equivalent to prednisolone dose more than 10 mg/d 5. Must receive a stable dose of steroid, immunosuppressant, and/or vitamin or its supplement within 2 weeks before enrollment 6. Must stop anxiolytics, hypnotics, or sleeping pills at least 2 weeks before enrollment 7. Understand and able to read and write the Thai language Exclusion Criteria: 1. Overlap with other connective tissue diseases 2. Pregnancy or lactation 3. Bedridden and confined to no self-care 4. Evidence of active malignant disease 5. Present uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatic, or renal diseases (Cr>1.4 mg/dl) 6. Present active infection that needs systemic antibiotic 7. Previous allergy to cannabinoid or their derivatives 8. Concomitant illegal drug used (amphetamine or its derivative, cocaine) 9. History of the previous cannabinoid using or concomitant any herbal included cannabinoid used 10. On-going anxiolytics, hypnotics, or sleeping pills used 11. In a period that needs immunosuppressant dose adjustment 12. Having active SSc that needs closed monitoring for disease progression (pulmonary hypertension, proteinuria, microscopic hematuria, digital gangrene, and progressive interstitial lung disease) 13. Having unstable cardiopulmonary disease (angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia) and risk of cardiovascular disease 14. Having a history of schizophrenia, concurrent active mood disorder, or anxiety disorders 15. Receiving the following medications that cause drug interaction with cannabinoids: fluoroquinolone, rifampicin, fluoxetine, warfarin |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Medicine, Faculty of Medicine, Khon Kaen University | Khon Kaen | |
Thailand | Scleroderma Clinic, Faculty of Medicine, Khon Kaen University | Khon Kaen |
Lead Sponsor | Collaborator |
---|---|
Khon Kaen University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The changing of sleep quality | The changing of sleep quality evaluated by the Thai Pittsburgh Sleep Quality Index* compare to baseline and a comparison between the treatment group and placebo group
*the score ranges from 0-to 21 and the higher score, the poorer sleep quality |
4 weeks | |
Other | The changing of quality of life | The changing of the quality of life evaluated by EuroQol group 5 dimensions (EQ-5D)* compare to baseline and a comparison between the treatment group and placebo group
*the index composes of 5 dimensions and each dimension includes 3 levels (no problems, some problems, and extreme problems), the higher level of the dimension, the poorer quality of life |
4 weeks | |
Other | The changing pain symptoms | 50% decrease of joint pain evaluated by VAS from 0-100* compare to baseline and a comparison between the treatment group and placebo group
*a higher scale, a more pain |
4 weeks | |
Other | The changing of cytokine level (transforming growth factor beta) | The changing of cytokine level compare to baseline and a comparison between the treatment group and placebo group | 4 weeks | |
Primary | The changing of appetite | 50% increase of appetite evaluated by a visual analogue scale (VAS) from 0-100* compared to baseline and a comparison between the treatment group and placebo group
*a higher score, a more appetite |
4 weeks | |
Secondary | The changing of serum transferrin level | The mean difference of serum transferrin level compare to baseline and a comparison between the treatment group and placebo group | 4 weeks | |
Secondary | An adverse event | An adverse event | 4 weeks |
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