Ayurvedic Treatment Package in Plaque Psoriasis

NCT ID: NCT04146558

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-04
• Study Completion Date: 2023-12-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Individualized internal ayurvedic treatment

Intervention Type: DRUG

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

External ayurvedic treatment

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

Group Type: ACTIVE_COMPARATOR

External ayurvedic treatment

Intervention Type: OTHER

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

Interventions

Individualized 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 Type: DRUG

External ayurvedic treatment

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College

UNKNOWN

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Holger Cramer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PNNM Ayurveda College

Shōranūr, Kerala, India

Countries

India

Other Identifiers

GI012019

Identifier Type: -

Identifier Source: org_study_id