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Ayurvedic Treatment Package in Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Individualized internal ayurvedic treatment
External ayurvedic treatment
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • PNNM Ayurveda CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internal ayurvedic treatment

External ayurvedic treatment

Arm 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

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

Outcomes

Primary Outcome Measures

Psoriasis-specific quality of life
Psoriasis specific DLQI scores

Secondary Outcome Measures

Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Psoriasis-specific quality of life
Psoriasis specific DLQI scores
Psoriasis-specific quality of life
Psoriasis specific DLQI scores
Adverse events
Adverse events
Adverse events

Full Information

First Posted
October 29, 2019
Last Updated
December 18, 2019
Sponsor
Universität Duisburg-Essen
Collaborators
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04146558
Brief Title
Ayurvedic Treatment Package in Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
November 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internal ayurvedic treatment
Arm Type
Experimental
Arm 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
Arm Title
External ayurvedic treatment
Arm Type
Active Comparator
Arm Description
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
Intervention Type
Drug
Intervention Name(s)
Individualized internal ayurvedic treatment
Intervention 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
Intervention Type
Other
Intervention Name(s)
External ayurvedic treatment
Intervention Description
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
Primary Outcome Measure Information:
Title
Psoriasis-specific quality of life
Description
Psoriasis specific DLQI scores
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Psoriasis Severity
Description
Psoriasis Area Severity Index (PASI) score
Time Frame
3 months
Title
Psoriasis Severity
Description
Psoriasis Area Severity Index (PASI) score
Time Frame
6 months
Title
Psoriasis Severity
Description
Psoriasis Area Severity Index (PASI) score
Time Frame
12 months
Title
Psoriasis-specific quality of life
Description
Psoriasis specific DLQI scores
Time Frame
3 months
Title
Psoriasis-specific quality of life
Description
Psoriasis specific DLQI scores
Time Frame
12 months
Title
Adverse events
Time Frame
3 months
Title
Adverse events
Time Frame
6 months
Title
Adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syal Kumar, MD, PhD
Phone
0049 201 - 174 25021
Email
s.kumar@kem-med.com
Facility Information:
Facility Name
PNNM Ayurveda College
City
Shoranur
State/Province
Kerala
ZIP/Postal Code
679 531
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eswara Sarma, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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Ayurvedic Treatment Package in Plaque Psoriasis

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