Ayurvedic Treatment Package in Plaque Psoriasis

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

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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Individualized internal ayurvedic treatment; Other: External ayurvedic treatment

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Syal Kumar, MD, PhD; Phone Number: 0049 201 - 174 25021; Email: s.kumar@kem-med.com

Study Locations

• India
  • Kerala
    • Shoranur, Kerala, India, 679 531
      • Recruiting
      • PNNM Ayurveda College
      • Contact: Eswara Sarma, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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
Active Comparator: External ayurvedic treatment; Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily	Other: External ayurvedic treatment; Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily

What is the study measuring?

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
Adverse events		3 months
Adverse events		12 months
Adverse events		6 months
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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Anticipated): November 15, 2020
• Study Completion (Anticipated): November 15, 2021

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: GI012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No