Ayurvedic Treatment Package in Plaque Psoriasis

Universität Duisburg-Essen

Status and phase: Unknown; Phase 3

Conditions: Psoriasis

Treatments: Drug: Individualized internal ayurvedic treatment; Other: External ayurvedic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04146558

GI012019

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Internal ayurvedic treatment

Experimental group

Description:

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

Treatment:

Drug: Individualized internal ayurvedic treatment

External ayurvedic treatment

Active Comparator group

Description:

Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily

Treatment:

Other: External ayurvedic treatment