Efficacy of individualized homoeopathic medicines in reducing serum alanine transaminase level in adults with non-alcoholic fatty liver disease: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Serum ALT level
研究概览
简要总结
NAFLD is the leading cause of chronic liver disease worldwide with an estimated prevalence of 32%. Although it is asymptomatic to begin with but it may progress to a steatohepatitis, cirrhosis and even primary liver cancer. As of now there is no established standard treatment of this clinical condition. Homoeopathy has immense potential to offer treatment for reduction of liver fat and serum liver enzymes but has remained seriously under-investigated till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of NAFLD in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 72 adults who are suffering from NAFLD at the OPD of D. N. De Homoeopathic Medical College and Hospital. Primary outcome assessment will be done by evaluating the serum ALT levels after 3 months of intervention. Chronic liver disease questionnaire(CLDQ) [secondary outcome], Measure Yourself Medical Outcome Profile version2.0 (MYMOP-2) [secondary outcome] every month up to 3 months. Lipid profile[secondary outcome] and Liver function Test[secondary outcome] will be assessed at baseline and after 3 months of intervention. Group differences will be analyzed statistically. Results will be published in a scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals with Grade I and Grade II Fatty liver established by Ultrasonography and ALT enzyme levels greater than upper limit of normal. (upper limit of normal ALT is considered to be more than 30 IU/mL in males and more than 19 IU/mL in females ). 2.Age 18 to 65 years. 3.Participants of either sex or transgender. 4.Participants having prior experience or knowledge of the treatment; example.
- •primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •1.Not providing with written informed consent of voluntary participation.
- •2.Regular or excessive use of alcohol, tobacco, substance abuse and any other addiction.
- •3.Individuals with NAFLD Fibrosis Score more than 0.
- •4.History of Viral hepatitis B or C, autoimmune hepatitis.
- •5.Cholestatic and metabolic liver diseases, hemochromatosis and liver transplants.
- •6.Combined with uncontrolled diabetes (participants under modern medications having poor glycemic control denoted by HbA1c more than 6.5%), uncontrolled hypertension (SBP more than 140 and DBP more than 90 mm of Hg with modern medications), renal or cardiac disease, stroke or any other severe systemic diseases affecting quality of life.
- •7.Person under corticosteroid therapy.
- •8.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill, mentally incompetent people.
- •9.Pregnant and puerperal women and lactating mother.
- •10.Self-reported immune-compromised state.
- •11.Already undergoing homoeopathic treatment within last 3 months for any other disease.
- •12.Simultaneous participation in any other trials.
结局指标
主要结局
Serum ALT level
时间窗: At baseline and after 3 months
次要结局
- Chronic liver disease questionnaire (CLDQ)(Baseline, every month, up to 3 months)
- Measure Yourself Medical Outcome Profile version 2 (MYMOP-2)(Baseline, every month, up to 3 months)
- Liver function test (Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, Total Protein, Albumin, Globulin, AST, ALP).(At baseline and after 3 months)
- Blood lipid profile (Triglycerides, Total cholesterol, Very-Low-Density Lipoprotein cholesterol, High-density Lipoprotein cholesterol, Low-Density Lipoprotein cholesterol)(At baseline and after 3 months)
研究者
Dr Rajarshi Mallick Choudhury
D. N. De Homoeopathic Medical College and Hospital