Ayurvedic Treatment Package in Plaque Psoriasis

Phase 3

• Conditions: Psoriasis
• Interventions: Other: External ayurvedic treatment; Drug: Individualized internal ayurvedic treatment

• Registration Number: NCT04146558
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Status Verified: 2019-12
• Study Start: 2019-12-04
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20
• Primary Completion: 2020-11-15
• Study Completion: 2021-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External ayurvedic treatment	External ayurvedic treatment	Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
Internal ayurvedic treatment	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

Primary Outcome Measures

Name	Time	Method
Psoriasis-specific quality of life	6 months	Psoriasis specific DLQI scores

Secondary Outcome Measures

Name	Time	Method
Psoriasis Severity	12 months	Psoriasis Area Severity Index (PASI) score
Adverse events	12 months
Psoriasis-specific quality of life	12 months	Psoriasis specific DLQI scores

Trial Locations

Locations (1)

PNNM Ayurveda College; 🇮🇳 Shoranur, Kerala, India