Ayurvedic Treatment Package in Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146558
• Other study ID #: GI012019
• Status: Recruiting
• Phase: Phase 3
• Start date: December 4, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: December 2019
• Source: Universität Duisburg-Essen
• Contact: Syal Kumar, MD, PhD
• Phone: 0049 201 - 174 25021
• Email: s.kumar[@]kem-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Other:
• External ayurvedic treatment
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily

Locations

Country	Name	City	State
India	PNNM Ayurveda College	Shoranur	Kerala

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis-specific quality of life	Psoriasis specific DLQI scores	6 months
Secondary	Psoriasis Severity	Psoriasis Area Severity Index (PASI) score	3 months
Secondary	Psoriasis Severity	Psoriasis Area Severity Index (PASI) score	6 months
Secondary	Psoriasis Severity	Psoriasis Area Severity Index (PASI) score	12 months
Secondary	Psoriasis-specific quality of life	Psoriasis specific DLQI scores	3 months
Secondary	Psoriasis-specific quality of life	Psoriasis specific DLQI scores	12 months
Secondary	Adverse events		3 months
Secondary	Adverse events		6 months
Secondary	Adverse events		12 months