Turmeric Based Therapy in the Treatment of Psoriasis: A Clinical Trial

Zagazig University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Psoriasis

Treatments: Device: NB-UVB; Drug: Turmeric Extract in Olive oil; Drug: calcipotriol/ Betamethasone; Drug: Turmeric Extract; Drug: Petrolatum

Study type: Interventional

Funder types: Other

Identifiers

NCT04071106

ZU-IRB#3950-20-8-2017

Details and patient eligibility

About

Psoriasis affects around 4% of world population. The disease could be disabling and disfiguring dermatologic condition. World Health Organization (WHO) has recently drawn the attention to the inadequate treatment options psoriasis patients suffer from among other problems. Furthermore, the available treatment options have many side effects. A lot of the effective treatment options are either expensive or not appropriate for hepatic patients who represent a large subset of Egyptian psoriatic patients. This highlights the need for inexpensive and safe alternative. The effectiveness of Turmeric in psoriasis treatment have been addressed in few reports. Having an immune modulatory effect especially as anti NFκB it is expected to be effective therapy with minimal side effect. Up to the investigator's knowledge this is the first study addressing the efficacy of combined turmeric and olive oil based topical therapy in psoriasis treatment

Full description

Psoriasis is a prevalent skin disorder. It affects around 4% of world's population. It can be disfiguring and disabling in severe cases. There is dysregulated immune response in psoriatic patients to unknown injurious agents with upregulation of Th1/Th17 pathways which is mediated via Nuclear Factor kappa B (NFκB). NFκB is a key player in psoriasis development; its activation and nuclear translocation is present in every step of the way of psoriasis starting from keratinocyte release of cytokines -in response to stress- to the maturation and activation of dendritic cells, to the continuous loop of T cell activation.

Turmeric extract has anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. It has inhibitory effects on NF-κB and various cytokines production.

In this clinical trial 5 groups of patients with mild to moderate psoriasis are recruited; group (A) Receiving the Turmeric extract based ointment only. Group (B) receiving Turmeric extract + olive oil based treatment. Group (C) will serve as negative control receiving only petrolatum base. Group (D) will receive NB UVB serving as positive control. Group (E) will receive established topical treatment serving as positive control.

Each patient will be assessed on weekly bases clinically for the disease severity using PASI score and via dermatoscope. Histopathological evaluation (H& E along with NFkB expression analysis) will be done at 4 points of time baseline, 4 weeks, 8 weeks, 12 weeks through the study.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with mild to moderate psoriasis vulgaris of any age & gender.
2. Patient didn't receive any systemic or topical therapy for psoriasis the last 4 weeks.

Exclusion criteria

1. Patients previously received topical or systemic therapy for psoriasis in the past 4 weeks.
2. Patients with pustular or erythrodermic psoriasis.
3. Patients with other dermatological diseases.
4. Patients have hypersensitivity from the active ingredients of the therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups, including a placebo group

Turmeric Extract group

Active Comparator group

Description:

10 psoriasis patients receiving turmeric based ointment levigated in glycerin twice daily and assessed for response and side effects weekly for 12 weeks

Treatment:

Drug: Turmeric Extract

Turmeric extract + olive oil group

Active Comparator group

Description:

10 psoriasis patients receiving turmeric extract levigated in olive oil instead of glycerin. The ointment will be applied twice daily for 12 weeks \& will be assessed weekly

Treatment:

Drug: Turmeric Extract in Olive oil

Petrolatum group

Placebo Comparator group

Description:

10 Psoriasis patients will receive the base of the therapeutic ointment which is the petrolatum. Patients will apply it twice daily and will be assessed weekly clinically and dermoscopically for 12 weeks

Treatment:

Drug: Petrolatum

NBUVB group

Active Comparator group

Description:

10 Psoriasis patients will receive two sessions of NBUVB weekly for 12 weeks and will be assessed weekly clinically and with dermoscope.

Treatment:

Device: NB-UVB

Established ttt group

Active Comparator group

Description:

10 Psoriasis patients will receive topical betamethasone dipropionate or calcipotriol cream twice daily for 12 weeks and will be assessed on weekly basis clinically and by dermoscope

Treatment:

Drug: calcipotriol/ Betamethasone