| CTRI Number |
CTRI/2024/03/064543 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Add On Effect Of Basti In Non-Alcoholic Fatty Liver Disease. |
|
Scientific Title of Study
|
Evaluating Clinical Efficacy Of Add On Effect Of Basti In Non-Alcoholic Fatty
Liver Disease Based On Sonographic Findings. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kachchhi Gopi Ashvinbhai |
| Designation |
Pg Scholar Department Of Kaya Chikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Kayachikitsa,6th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,Mathura Road,New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9429032021 |
| Fax |
|
| Email |
gopikachchhi901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kajaria |
| Designation |
Assistant Professor, Department Of Kaya Chikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Kayachikitsa,6th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,Mathura Road,New Delhi
New Delhi
DELHI
110076
India |
| Phone |
8826167515 |
| Fax |
|
| Email |
divyakajaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kachchhi Gopi Ashvinbhai |
| Designation |
Pg Scholar Department Of Kaya Chikitsa |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department Of Kayachikitsa,6th Floor,Academic Block,Block C,All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,Mathura Road,New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9429032021 |
| Fax |
|
| Email |
gopikachchhi901@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,Mathura Road,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kachchhi Gopi Ashvinbhai |
All India Institute Of Ayurveda |
Department of Kayachikitsa, OPD no.1, Dround Floor, Hospital block, All India Institute Of Ayurveda,Gautampuri,Sarita Vihar,Mathuraroad,New Delhi 110076
New Delhi
DELHI |
9429032021
gopikachchhi901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 358/26.10.2023/PG.20/2023 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: AMADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: CharakSamhita Siddhi Sthana Chapter-8, Slok- 9and 10, Procedure details: Niruha Basti For 3days
Anuvasan Basti For 2days)
| | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: Empty Stomach- Dhanya(3gm) And Saunth (3gm) Sadhita Jalpaan -100ml
After Lunch - 50 ml Takra(Buttermilk) Mixed With Trikatu Churna(2gm)
After Dinner- Trikatu Phant (3gm Of Trikatu Added In 50 ml O, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Take Water Only When Feels Thirsty And Take Food Only When Feels Hunger
Use Jaggery Instead Of Sugar
Prefer Saindhav Instead Of Normal Salt
Eat Freshly Prepared Warm Food
Take Food When Feel Hungry And Previous Meal Digested
Sleeping For 7 To 8 Hours, 9 To 10 Pm To 5 To 6 Am
, Apathya:Maida, Dahi, Packed And Junk Food (Maggy, Pasta, Momos, Pizza ,Etc)Cold Drinks, Ice Cream, Flavoured Milk, Packed Roasted Snacks, Fermented Packed Food Items Like Bread, All Types Of Western Food, Additive Items Like Pickles, Papad, Jam, Fried Foods,Added Salt,Alcohol,Cheese,Paneer,Juice.
Avoid Day Sleeping, Night Awakening
Avoid Stress,Anger
Suppression Of Urges
Smoking,Tobacco,Any Addiction
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Previously diagnosed and newly diagnosed case of NAFLD (fatty liver grade 1 or 2) confirmed by
Sonography (USG Or Fibroscan)
2.Grade 1 & Grade 2 NAFLD in USG Or F0 to F2 Less Than 10kPa Score,CAP Score -S1 248-260db per m,S2
260-290 db per m,IQR per M-30 Percent or less in Fibroscan.
3.Patients willing to participate in the clinical trial. |
|
| ExclusionCriteria |
| Details |
1.Patent having NASH/NAFLD associated with Metabolic diseases
2. Patients having NAFLD Grade 3 Or More
3. Patients with Type 2 diabetes
4. Known case of Hypertension
5. Known case of hypothyroidism or hyperthyroidism
6. Patients having BMI Greater than 30,
7. Patients having deranged liver functions (AST per ALT Greater than 2 folds). Patients suffering from Hepatitis,
Cirrhosis of liver, Ascites, Portal hypertension (PTH), patient having other chronic liver diseases,
etc.
8. Patients having deranged renal functions Or chronic kidney diseases.
9. Patients suffering from AIDS, Tuberculosis and other infectious diseases.
10. Any Malignancy.
11. Pregnant and lactating women.
12. Patient on long term medication (Hepatotoxic medication like NSAID, Rifampicin,steroid).
13. Patients consuming Alcohol or other narcotic substance. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes In Sonography Findings (Expecting From Grade II To Grade I Or 0 And From Grade I To Grade 0) Along With Changes In Clinical Presentations (Expecting 5% To 10% Reductions In Signs And Symptoms). |
Day 1
30 Days
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Changes In Waist Circumference
2 Changes In Liver Function Tests
3 Changes In Lipid Profile
4 Changes In Vitamin D Level
5 Improvement In Quality Of Life. |
Day 1
Day 30
Day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nonalcoholic Fatty Liver Disease, A Metabolic Disorder Of Hepatic Origin, Is Increasingly Common Worldwide. NAFLD Is A Wide Spectrum Of Diseases Characterized By Fatty Infiltration Of The Liver, Simple Steatosis, Steatohepatitis, Advance Fibrosis And Cirrhosis.Iit Is A Condition Where Excess Fat Gets Accumulates In The Liver Cells In Individuals Having No Significant History Of Alcohol Consumptionii. The Main Cause Of NAFLD Is Imbalance Between Rate Of Import / Synthesis And Rate Of Export /Catabolism Of Fatty Acid In Liver Or Reduced Synthesis Of VLDL & Increased Hepatic Triglycerides Synthesis Due To Decreased Oxidation Of Fatty Acid Or Increased Free Fatty Acid Being Delivered To The Live. PRIMARY OBJECTIVES 1. To Evaluate The Clinical Efficacy Of Basti In Reducing The Liver Fat Deposition In NAFLD. SECONDARY OBJECTIVES 1. To Prevent The Progression And Complication Of The Disease. 2. To Understand The Relation (Correlation Coefficient) * Between Vitamin D And NAFLD (Grade I &II). 3. To Understand The Significance Of Fatty Liver Index For Diagnosing NAFLD In Non-Diabetic And Non- Metabolic Syndrome Associated NAFLD Patients. 4. To Improve The Quality Of Life In The Patients Of NAFLD.
|