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Ayurvedic Treatment Package in Plaque Psoriasis

U

Universität Duisburg-Essen

Status and phase

Unknown
Phase 3

Conditions

Psoriasis

Treatments

Drug: Individualized internal ayurvedic treatment
Other: External ayurvedic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04146558
GI012019

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

Internal ayurvedic treatment
Experimental group
Description:
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
Treatment:
Drug: Individualized internal ayurvedic treatment
External ayurvedic treatment
Active Comparator group
Description:
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
Treatment:
Other: External ayurvedic treatment

Trial contacts and locations

1

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Central trial contact

Syal Kumar, MD, PhD

Data sourced from clinicaltrials.gov

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