Participant receives both curcumin and prednisolone. Curcumin for 11 days, prednisolone for 10 days. Curcumin: 2 tablets (each contains 100 mg curcumin) twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone.placebo and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone-placebo for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon-placebo: One capsule every morning.

Insulin Resistance

Non-Alcoholic Fatty Liver Disease

Curcumin is given together with prednisolone

Curcumin Liposome

Prednisolone is given together with curcumin-placebo

Prednisolone

Prednisolone-placebo is given together with curcumin-placebo

Placebos

Center for Clinical Metabolic Research

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance in Overweight and Obese Participants

homeostatic model assessment of insulin resistance is calculated before and after intervention

Measured by MR spectroscopy of the liver (unit: %)

Estimated by collecting urin for 4-5 hours, measuring volume of urine and urea concentration

Feces sample before and after intervention

subcutaneously, interstitial measurement (concentration of glucose) every 15 minutes in the intervention period

icare 100 tonometer measurement (unit: mmHg)

measured by bioimpedance (units: kg and %)

MR-spectroscopy measurement (unit: cm3 at L3-level, 1 cm thick slice)

visual analogue scale evaluation (no visible numbers/points, just a clear line)

Evaluated by calculating ingested meal at ad libitum meal at test days (unit: grams and calories)

Visual analogue scale (no points/number visible, just a clear line)

Pernille Høgh Hellmann

Medical Doctor, primary investigator

University Hospital, Gentofte, Copenhagen

After study day 1, participants are randomized (1:1:1) to one of three treatments: 1) Prednisolon and Curcumin, 2) Prednisolon and placebo or 3) Placebo and placebo.

Spironolactone ARROW ® 75 mg, 150mg, orally, once a day during all the trial (12 months: 6 months on double-blinded spironolactone then 6 months on open-label spironolactone), + topical therapy during all the trial (benzoyl peroxide 5%)

(Doxycycline Sandoz 100 mg), 100mg/day during 3 months followed by placebo during 3 months, on double-blinded + topical therapy during all the trial (benzoyl peroxide 5%

Acne Vulgaris

Dispensation of spironolactone at each visit according to the arm description described above.

spironolactone

Dispensation of doxycycline then placebo, at each visit according to the arm description described above.

Doxycycline

Chru Brest

CHU Caen

CHU Grenoble

CH La Rochelle

CH Le Mans

CHU de Nantes - Dermatologie

CHU Poitiers

Cabinet du Dr Jean-Paul Claudel

CHRU Tours

Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

The treatment's efficacy will be determined by the rate of success in each arm. The best rate of success between Month 4 and Month 6 will be chosen for the final result. Rate of success, defined by a decrease of both Adult Female Acne Scoring Tool (AFAST) scores 1 and 2:
AFAST score 1: decrease of at least 2 grades compared to baseline or to grade 0 if the baseline was at 1 and
AFAST score 2: decrease to grade 1 if baseline was > 1 or to grade 0 if the baseline was at 1
AFAST 1 (also called GEA) assesses the comedones (open and closed), the non-inflammatory lesions, the papules and pustules and the nodules. The stage is defined according to a global evaluation of severity of acne and ranges from Grade 0 (no acne) to Grade 5 (the worse situation).
AFAST 2 assesses acne on an area from the left and right mandibular zone to the upper edge of the trunk and ranges from Grade 0 (no acne) to Grade 3 (the worse situation).

Number and type of Adverse Events (AE) and Serious Adverse Events (SAE) occurring from the beginning of the treatment until end of the follow-up

Number of patients with AFAST score 1 (GEA) at 0 or 1.

Number of patients with AFAST score 2 (Mandibular) at 0 or 1.

Number of patients with both AFAST score 1 and AFAST score 2 at 0 or 1.

EQ-5D (EuroQol 5 dimensions) questionnaire: The questionnaire focuses on five dimensions: mobility, personal autonomy, current activities, pain/discomfort, and anxiety/depression. For each of these dimensions, three answers are possible.

Cardiff Acne disability Index (CADI) is a disease-specific questionnaire measuring disability induced by acne.

Presence of P acnes, M Furfur and S epidermidis, aureus

Number of inflammatory lesions of the face

Number of retentional lesions of the face

Factor F2 of ECLA scale ECLA ("Echelle de Cotation des Lésions d'Acné") is a scale for acne proposed by the dermatology research team of Nantes University Hospital. It is composed of 3 factors: Factor 1 (F1) counts the acne lesions on the face; Factor 2 (F2) counts the lesions acne on the trunk and Factor 3 (F3) counts the scars. In this study, the factor F2 will be used. The factor F2 assesses the extensive character of acne lesions on 5 defined areas: cervical areas (F2N); chest areas (F2C); back area (F2B) and arm area (F2A) according to a qualitative scale 0=absent, 1=poor 2=medium 3=significant. It is completed by the count of the present nodules in each area.

number of patients with relapse, defined as follows :
AFAST score 1 (GEA score): increase of 2 points versus score of previous visit, in case of success Or
AFAST score 2 (mandibular score): increase of 1 point versus score of previous visit, in case of success

Number of patients with a reappearance of 10% and more of inflammatory lesions.

Nantes University Hospital

The products used in both arms will be over-encapsulated by the Pharmacy of Nantes University Hospital

Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.

Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.

Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.

Pain

Intravenous Propofol Injection

I.V injection of 10 ml normal saline

I.V injection with 0.25mic/kg of dexmedetomidine

I.V injection of 0.50mic/kg of dexmedetomidine

Effect of Dexmedetomidine on Pain Due to Propofol Injection

Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial

After injecting study drugs the pain score after propofol was assessed by using visual rating scale and given score according to severity of pain 0 = no pain,
= mild pain or soreness,
= moderate pain and
= severe pain associated with facial grimacing, arm withdrawal, movement or both.

All patient were observed for 2-hrs in recovery room and were asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as
0-No recall of pain
1-Recall of pain present.

phlebitis/triglyceride

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

Effect of Dexmedetomidine on Pain Due to Propofol Injection

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