Psoriasis Clinical Trial
Official title:
Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
Verified date | January 2020 |
Source | Jinnah Postgraduate Medical Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective of the study is to determine the efficacy of low dose naltrexone in the patients of psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center, Karachi. All patients with mild, moderate and severe psoriasis with age above 13 years without any co-morbid, were prescribed tablet Naltrexone 6 mg daily after assessing PASI, BSA and DLQI scores before starting treatment. Patients were called monthly for follow up to monitor lipid profiles and liver function tests. After 3 months of treatment, PASI, BSA and DLQI scores were assessed again. The results were significant when analysed with paired t test in SPSS 23.
Status | Completed |
Enrollment | 42 |
Est. completion date | September 30, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 60 Years |
Eligibility |
Inclusion Criteria: - minimum age 13 years - maximum age 60 years - both males and females affected with mild, moderate and severe psoriasis. Exclusion Criteria: - hypertension - cardiovascular disorders - pregnancy - lactation - renal failure - liver failure - hypersensitivity to drug |
Country | Name | City | State |
---|---|---|---|
Pakistan | Jinnah postgraduate medical centre | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Jinnah Postgraduate Medical Centre |
Pakistan,
Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943. — View Citation
Rendon A, Schäkel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6). pii: E1475. doi: 10.3390/ijms20061475. Review. — View Citation
Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in the severity of disease | change in the percentage of area of body involved with disease (1 hand = 1%) | 12 weeks. |
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