Ayurvedic Treatment Package in Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Open Label Clinical Trial on the Efficacy of an Ayurvedic Treatment Package on Symptom Severity and Quality of Life in Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Individualized internal ayurvedic treatment
* Other: External ayurvedic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internal ayurvedic treatment<br>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 | Drug: Individualized internal ayurvedic treatment<br>* 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<br>|
| Active Comparator: External ayurvedic treatment<br>Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily | Other: External ayurvedic treatment<br>* Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis-specific quality of life | Psoriasis specific DLQI scores | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Severity | Psoriasis Area Severity Index (PASI) score | 3 months | 
| Psoriasis Severity | Psoriasis Area Severity Index (PASI) score | 6 months | 
| Psoriasis Severity | Psoriasis Area Severity Index (PASI) score | 12 months | 
| Psoriasis-specific quality of life | Psoriasis specific DLQI scores | 3 months | 
| Psoriasis-specific quality of life | Psoriasis specific DLQI scores | 12 months | 
| Adverse events |  | 3 months | 
| Adverse events |  | 6 months | 
| Adverse events |  | 12 months |