CTRI Number |
CTRI/2017/06/008941 [Registered on: 29/06/2017] Trial Registered Prospectively |
Last Modified On: |
29/06/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Study to assess an ayurveda treatment protocol combined with diet life style regimen in the reversal of non alcoholic fatty liver disease. |
Scientific Title of Study
|
‘A randomized controlled clinical trial to assess the comparative efficacy of ayurveda treatment protocol and diet-lifestyle regimen in the reversal of first grade non-alcoholic fatty liver disease’. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vandana RaniM |
Designation |
Professor |
Affiliation |
Amrita school of ayurveda |
Address |
Department of swasthavritta
Amrita school of ayurveda
Clappana P.O, Karunagappally
Thiruvananthapuram KERALA 690525 India |
Phone |
9446441441 |
Fax |
|
Email |
vandanarani72@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vandana RaniM |
Designation |
Professor |
Affiliation |
Amrita school of ayurveda |
Address |
Department of swasthavritta
Amrita school of ayurveda
Clappana P.O, Karunagappally
Thiruvananthapuram KERALA 690525 India |
Phone |
9446441441 |
Fax |
|
Email |
vandanarani72@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vandana RaniM |
Designation |
Professor |
Affiliation |
Amrita school of ayurveda |
Address |
Department of swasthavritta
Amrita school of ayurveda
Clappana P.O, Karunagappally
Thiruvananthapuram KERALA 690525 India |
Phone |
9446441441 |
Fax |
|
Email |
vandanarani72@gmail.com |
|
Source of Monetary or Material Support
|
Amrita school of ayurveda
Clappana P.O, Karunagappally
Kollam-690525 |
|
Primary Sponsor
|
Name |
Amrita School of Ayurveda |
Address |
Vallikkavu, Clappana PO,Karunagapally,Kollam |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Vandana Rani M |
Amrita ayurveda hospital |
Vallikkavu, Clappana PO,Karunagapally,Kollam,Kerala Kollam KERALA |
9446441441
vandanarani72@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Amrita Institute of Heath Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Apparently healthy people who are not taking allopathic medicines for any chronic diseases of 20-55years of both sexes, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Comparator Agent - Group for whom Ayurveda Diet and Exercise shall be prescribed . |
Comparator Agent- Group will be given Ayurveda diet and exercise. |
Intervention |
Intervention Group - for whom Ayurveda Diet , Exercise and Ayurveda treatment protocol shall be prescribed.
Comparator Agent - Group for whom Ayurveda Diet and Exercise shall be prescribed . |
Intervention Group- Group protocol will be exercised along with Ayurveda diet and exercise
Comparator Agent- Group will be given Ayurveda diet and exercise. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
People of age in b/w 20-55yrs of both sex.
Apparently healthy people who are not taking allopathic medicines for any chronic diseases.
|
|
ExclusionCriteria |
Details |
People below 20 yrs and above 55yrs.
Alcoholics
Other liver disorders like Viral hepatitis, Hepatitis C etc.
Type 2 Diabetes
Pregnancy
Other chronic diseases.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Blood lipid profile, Liver Function Test will get improve
|
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
US Abdomen- Normal liver scan |
3 months |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
27/07/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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. |