Ayurvedic Treatment Package in Plaque Psoriasis

NCT04146558 | Completed Phase 3

• 1 other identifier: GI012019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Psoriasis-specific quality of life

  Psoriasis specific DLQI scores

  6 months

Secondary Outcomes (8)

• Psoriasis Severity

  3 months

• Psoriasis Severity

  6 months

• Psoriasis Severity

  12 months

• Psoriasis-specific quality of life

  3 months

• Psoriasis-specific quality of life

  12 months

Study Arms (2)

Internal ayurvedic treatment

EXPERIMENTAL

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

External ayurvedic treatment

ACTIVE COMPARATOR

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

Other: External ayurvedic treatment

Interventions

Individualized internal ayurvedic treatment 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

Internal ayurvedic treatment

External ayurvedic treatment OTHER

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

External ayurvedic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College: collaborator

Study Sites (1)

PNNM Ayurveda College

Shōranūr, Kerala, 679 531, India

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: December 4, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)