Study to assess an ayurveda treatment protocol combined with diet life style regimen in the reversal of non alcoholic fatty liver disease.

Not yet recruiting

• Conditions: Apparently healthy people who are not taking allopathic medicines for any chronic diseases of 20-55years of both sexes

• Registration Number: CTRI/2017/06/008941
• Lead Sponsor: Amrita School of Ayurveda

Brief Summary

Non alcoholic Fatty Liver Syndrome (NAFLD) is now regarded as the hepatic manifestation of metabolic syndrome. Three lifestyle diseases i.e.  Diabetes, obesity and hyperlipidemia  are considered as risk factors. 70% Non-alcoholic Steatohepatitis   had one or more of the above risk factors. Prevalence of NAFLD in asymptomatic middle-aged patients is as high as 46.0%.  When they continue  the same life style it will lead to fatty liver infiltration and then to  liver cirrhosis or even liver cancer. So an early intervention that reverses the pathology might decrease the morbidity and mortality rate. Current treatment focuses on decreasing insulin resistance, Cholesterol management and Weight loss.  Studies on drugs like metformin, thiazolidinediones prescribed for NAFLD are found to have significant side effects. Bariatric surgery has been proved as effective but is expensive. Studies on first-line treatment approach to NAFLD based on diet and lifestyle modification are nonrandomized and short term. Due to paucity of data it is difficult to produce evidence-based recommendations about dietary modifications and exercise in NAFLD patients. Moreover, dietary treatment alone is limited by the lack of compliance and the frequent regain of weight at follow-up. So an Ayurveda treatment protocol that is safe and inexpensive, effective in the reversal of first grade fatty liver is the need of the hour.

Subjects who meet inclusion criteria and are willing to participate in the study will be assigned into two groups of 50 each according to Simple Random Sampling method. They are 1) Control Group:- for whom Ayurveda Diet and Exercise  shall be prescribed and 2) Trial Group:- for whom  Ayurveda Diet , Exercise and Ayurveda medicine shall be prescribed . At baseline all study subjects will be screened for blood lipid profile, LFT, and US abdomen to confirm diagnosis. For the Control Group Diet preparations wholesome diet suitable for diabetes ,obesityand dyslipedemia shall be given. Exercise regimen shall be according to their BMI, Occupation, Constitution , Season and Strength. For the Trial Group apart from Ayurveda Diet and exercise, treatment aiming at  treatment for reducing fat, increasing digestive power, that increases digestion and due regulation of dosha followed by hepato protective Rasayana  will be prescribed. Each group shall be constantly monitored separately for three months. Blood tests done at base line will be repeated in participants who successfully complete the treatment within the prescribed time. Pre test post comparison of the quantitative variables will be analysed by paired t test or Wilcoxon signed rank test according to the nature of the data. Pre test post test comparison of qualitative variables will be analysed by McNemar test. Between groups differences of the quantitative variables will be evaluated by independent sample test. A p-value of <0.05 will be considered as the level of significant. Data analysis will be performed using SPSS ver 17.0.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-06-29
• Study Start: 2017-07-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• People of age in b/w 20-55yrs of both sex.
• Apparently healthy people who are not taking allopathic medicines for any chronic diseases.

Exclusion Criteria

• People below 20 yrs and above 55yrs.
• Alcoholics Other liver disorders like Viral hepatitis, Hepatitis C etc.
• Type 2 Diabetes Pregnancy Other chronic diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood lipid profile, Liver Function Test will get improve	3 months

Secondary Outcome Measures

Name	Time	Method
US Abdomen- Normal liver scan	3 months

Trial Locations

Locations (1)

Amrita ayurveda hospital; 🇮🇳 Kollam, KERALA, India

Amrita ayurveda hospital

🇮🇳Kollam, KERALA, India

Dr Vandana Rani M

Principal investigator

9446441441

vandanarani72@gmail.com