A Randomized Open Label Clinical Trial on the Efficacy of an Ayurvedic Treatment Package on Symptom Severity and Quality of Life in Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- Individualized internal ayurvedic treatment
- Conditions
- Psoriasis
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Psoriasis-specific quality of life
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
Psoriasis is a chronic, immune-mediated inflammatory skin disease that is associated with substantial impairment of physical and psychological quality of life. The conventional treatment protocols manages the condition but with remissions and relapses which create anxiety in patients. Many of the patients withdraw from active social life as the disease attains chronicity. Several studies are pointing towards a conjoint management strategy incorporating the traditional and alternate medical systems. In this regard, Ayurveda is commonly used by psoriatic patients in India. Considering this fact it is high time to conduct a study to scientifically evaluate the efficacy of Ayurvedic treatment protocol in managing psoriasis as well as its potential to improve the quality of life.
Investigators
Holger Cramer
Professor
Universität Duisburg-Essen
Eligibility Criteria
Inclusion Criteria
- •Patients with psoriasis having age 18 years or more
- •Patients with moderate-to-severe plaque psoriasis with a PASI score of 12 or higher
- •Psoriasis diagnosed 6 months or more before study entry
- •Those who are poorly controlled based on physicians assessment with topical treatments, phototherapy, systemic therapy, or a combination of these therapies.
- •Participants who have given informed consent.
Exclusion Criteria
- •Participants with other systemic illnesses
- •Lactating and pregnant mothers.
- •Alcohol dependence/Narcotic dependence /Steroid dependence
- •In the judgment of the investigator, unable or unwilling to follow the protocol and instructions
Arms & Interventions
Internal ayurvedic treatment
All possible internal preparations will be administered for a period of 12 months. All administered preparations with its dosage and duration will be documented All preparations will be subjected to lab test for clearing heavy metal and pesticide content before the administration
Intervention: Individualized internal ayurvedic treatment
External ayurvedic treatment
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
Intervention: External ayurvedic treatment
Outcomes
Primary Outcomes
Psoriasis-specific quality of life
Time Frame: 6 months
Psoriasis specific DLQI scores
Secondary Outcomes
- Psoriasis Severity(12 months)
- Adverse events(12 months)
- Psoriasis-specific quality of life(12 months)