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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Five groups will be included in the study Group 1: 10 Psoriatic patients receive turmeric extract based ointment . Group 2: 10 psoriatic patients will receive turmeric extract + olive oil based ointment.

Group 3: 10 psoriatic patients will receive petrolatum base as negative control.

Group 4: 10 psoriatic patients will receive NBUVB as positive control. Group 5: 10 psoriatic patients will receive established topical treatment serving as 2nd positive control.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patients do not know whether they are receiving the drugs with active ingredients or negative control. The pathologist will be masked regarding the groups and the point of time before or after therapy.

Study Groups

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Turmeric Extract group

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

Group Type ACTIVE_COMPARATOR

Turmeric Extract

Intervention Type DRUG

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Turmeric extract + olive oil group

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

Group Type ACTIVE_COMPARATOR

Turmeric Extract in Olive oil

Intervention Type DRUG

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Petrolatum group

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

Group Type PLACEBO_COMPARATOR

Petrolatum

Intervention Type DRUG

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

NBUVB group

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

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type DEVICE

Patients will receive 2 sessions of NB-UVB phototherapy and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Established ttt group

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

Group Type ACTIVE_COMPARATOR

calcipotriol/ Betamethasone

Intervention Type DRUG

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Interventions

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Turmeric Extract

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Intervention Type DRUG

Turmeric Extract in Olive oil

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Intervention Type DRUG

Petrolatum

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Intervention Type DRUG

NB-UVB

Patients will receive 2 sessions of NB-UVB phototherapy and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Intervention Type DEVICE

calcipotriol/ Betamethasone

Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No