PsoriasisPhase 3NCT04146558
Ayurvedic Treatment Package in Plaque Psoriasis
A Phase 3 study testing Individualized internal ayurvedic treatment and External ayurvedic treatment in people with Psoriasis, run by Universität Duisburg-Essen at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Individualized internal ayurvedic treatment and External ayurvedic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 4 Dec 2019to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Psoriasis
- Being tested
- Individualized internal ayurvedic treatment, External ayurvedic treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized internal ayurvedic treatmentDrug
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
External ayurvedic treatmentOther
Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
| Study group | Role | What they receive |
|---|---|---|
| Internal ayurvedic treatment | Experimental | 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 Receives: Drug: Individualized internal ayurvedic treatment |
| External ayurvedic treatment | Active comparator | Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily Receives: Other: External ayurvedic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis-specific quality of life
Psoriasis specific DLQI scores
Measured: 6 months
Secondary outcomes (8)
Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Measured: 3 months
Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Measured: 6 months
Psoriasis Severity
Psoriasis Area Severity Index (PASI) score
Measured: 12 months
Psoriasis-specific quality of life
Psoriasis specific DLQI scores
Measured: 3 months
Psoriasis-specific quality of life
Psoriasis specific DLQI scores
Measured: 12 months
Adverse events
Measured: 3 months
Adverse events
Measured: 6 months
Adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start4 Dec 2019
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146558
- Sponsor's protocol ID
- GI012019
- Status last verified
- Jun 2025
- First submitted
- 29 Oct 2019
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04146558
- Acronym / sponsor ID
- GI012019
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal ayurvedic treatment | Experimental | Drug: Individualized internal ayurvedic treatmentAll 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 |
| External ayurvedic treatment | Active comparator | Other: External ayurvedic treatmentApplication of warm external oil (Ayyapala kera tailam) on affected parts twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized internal ayurvedic treatmentAll 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 | Internal ayurvedic treatment |
| External ayurvedic treatmentApplication of warm external oil (Ayyapala kera tailam) on affected parts twice daily | Other | External ayurvedic treatment |
Primary outcome
Psoriasis-specific quality of life
Time frame: 6 months
Psoriasis specific DLQI scores
8 secondary outcomes
Psoriasis Severity
Time frame: 3 months
Psoriasis Severity
Time frame: 6 months
Psoriasis Severity
Time frame: 12 months
Psoriasis-specific quality of life
Time frame: 3 months
Psoriasis-specific quality of life
Time frame: 12 months
Adverse events
Time frame: 3 months
Adverse events
Time frame: 6 months
Adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Individualized internal ayurvedic treatment and External ayurvedic treatment in people with Psoriasis, run by Universität Duisburg-Essen at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis-specific quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.