Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized,Placebo-controlled,Double-blind Trial of Phyllanthus Urinaria (Hepaguard®) in Adults With Nonalcoholic Steatohepatitis
Brief Summary: Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a progressive course and may result in liver cirrhosis and liver cancer. However, there is yet proven treatment for this disorder. In cell line and animal studies, we have shown that Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the efficacy in NASH has not been confirmed in humans.

This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy. Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be further analyzed.


Options:
A: Arm Label: Lepicol probiotic & prebiotic formula+simple lifestyle advice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lepicol probiotic & prebiotic formula, Other: Simple lifestyle advice | Arm Label: Simple lifestyle advice alone; Type: PLACEBO_COMPARATOR; Interventions: Other: Simple lifestyle advice | Intervention Type: DRUG; Name: Lepicol probiotic & prebiotic formula; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice | Intervention Type: OTHER; Name: Simple lifestyle advice; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice, Simple lifestyle advice alone
B: Arm Label: MRI(+ve),; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo | Arm Label: MRI(-ve); Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: 200mg of Palm vitamin E (tocotrienols) or placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: 200mg of Palm vitamin E (tocotrienols) or placebo; Assigned to Arm(s): MRI(+ve),, MRI(-ve)
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Omega-3 carboxylic acids 4g / day; Type: EXPERIMENTAL; Interventions: Drug: Omega-3 carboxylic acid | Arm Label: Fenofibrate 200mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fenofibrate 200mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Omega-3 carboxylic acid; Assigned to Arm(s): Omega-3 carboxylic acids 4g / day | Intervention Type: DRUG; Name: Fenofibrate 200mg; Assigned to Arm(s): Fenofibrate 200mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Hepaguard; Type: ACTIVE_COMPARATOR; Interventions: Drug: Phyllanthus urinaria | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Phyllanthus urinaria; Assigned to Arm(s): Hepaguard | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D