NCT00681733Unknown不适用
A Study Of Metabolic Factors And Efficacy Of Pentoxifylline Versus Pioglitazone In Lean And Obese Nash (Non-Alcoholic Steatohepatitis) Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in metabolic profile and histology
研究概览
简要总结
- To assess the metabolic factors in lean and obese patients with NASH.
- To compare the efficacy of pentoxifylline versus pioglitazone on the metabolic profile and liver histology of NASH patients.
详细描述
A total of 40 patients with biopsy proven NASH will be enrolled.
Inclusion criteria
- Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver.
- ALT > 1.2 times the upper limit of normal for > 6 months.(atleast three readings one month apart)
- Liver Biopsy showing steatosis affecting >10% of hepatocytes with necroinflammatory activity, ballooning hepatocytes &/ or fibrosis.
Exclusion criteria
- Alcohol intake of more than 20g/wk
- Evidence of viral/ autoimmune hepatitis
- PBC (Primary biliary cirrhosis)
- Biliary obstrution
- Wilson disease
- Haemchromatosis
- Decompensated cirrhosis
- Drug ingestion of the follwing drugs for a period of more than 4 weeks during past 6 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biopsy proven NASH will be enrolled. Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver.
- •ALT > 1.2 times the upper limit of normal for > 6 months.(atleast three readings one month apart)
- •Liver Biopsy showing steatosis affecting >10% of hepatocytes with necroinflammatory activity, ballooning hepatocytes &/ or fibrosis.
排除标准
- •Alcohol intake of more than 20g/wk
- •Evidence of viral/ autoimmune hepatitis
- •PBC (Primary biliary cirrhosis)
- •Biliary obstrution
- •Wilson disease
- •Haemchromatosis
- •Decompensated cirrhosis
- •Drug ingestion of the follwing drugs for a period of more than 4 weeks during past 6 weeks - Amiodarone, Methotrexate, Perhexiline, Glucocorticoids, Estrogens, Tamoxifen, Nifedipine, Diltiazem, Tamoxifen.
- •DM Type I
研究组 & 干预措施
A
Experimental
Pioglitazone
干预措施: Pioglitazone (Drug)
B
Active Comparator
Pentoxifylline
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Improvement in metabolic profile and histology
时间窗: 6 months
次要结局
- Side effects(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparison of the metabolic factors in obese patients’ pre and post bariatric surgery after 3 months trial of aerobic versus strengthening exercisesMorbid obesity.Morbid obesityIRCT201111214251N8Vice chancellor for research, Tehran University of medical sciences90
已完成
不适用
To see the improvement in blood sugar control in non-obese type 2 diabetic mellitus patients with BMI 22 to 35 after different types of metabolic operations.CTRI/2010/091/002938Self20
已完成
不适用
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat MealNutritional InterventionObesityNCT01995110Agroscope Liebefeld-Posieux Research Station ALP14
进行中（未招募）
不适用
Etude des effets métaboliques et staturaux de deux modes de traitement par hormone de croissance recombinante des enfants nés petits pour l'âge gestationnel avec déficit statural persistant. Pharmacogénomique de la réponse métabolique et staturale de l'hormone de croissance - SGAEnfant né Petit pour l'Age Gestionnel traités par rhGHMedDRA version: 8.1Level: PTClassification code 10053759Term: Growth retardationEUCTR2007-003850-26-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
尚未招募
不适用
Risk of metabolic syndrome in male patients with early onset male pattern hair lossCTRI/2022/01/039509Department of Dermatology St Johns Medical College