| CTRI Number |
CTRI/2022/02/040321 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of NAFLD through Ayurveda |
|
Scientific Title of Study
|
Clinical Efficacy and safety of Arogyavardhini Vati and Pippalyadyasava in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) –An open level prospective clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Banamali Das |
| Designation |
RESEARCH OFFICER |
| Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
CENTRAL AYURVEDA RESEARCH INSTITUTE FOR HEPATOBILIARY DISORDERS
ROOM NO 18
Khordha
ORISSA
751029
India |
| Phone |
8249683316 |
| Fax |
|
| Email |
banamali.d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banamali Das |
| Designation |
RESEARCH OFFICER |
| Affiliation |
CCRAS |
| Address |
CENTRALAYURVEDA RESEARCH INSTITUTE
Out Patient Department
Room no 3
Khordha
ORISSA
751029
India |
| Phone |
8249683316 |
| Fax |
|
| Email |
banamali.d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banamali Das |
| Designation |
RESEARCH OFFICER |
| Affiliation |
CCRAS |
| Address |
CENTRALAYURVEDA RESEARCH INSTITUTE
Out Patient Department
Room no 3
Khordha
ORISSA
751029
India |
| Phone |
8249683316 |
| Fax |
|
| Email |
banamali.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
61-65 INSTITUTIONAL AREA
OPPOSITE D BLOCK,JANAKPURI
NEW DELHI |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
61-65 Institutional Area
Opposite D block
Jnakpuri
New Delhi |
| Type of Sponsor |
Other [AUTONOMOUS INSTITUTE UNDER AYUSH] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BANAMALI DAS |
CENTRAL AYURVEDA RESEARCH INSTITUTE |
Out Patient department
Room no 3
Bharatpur bhubaneswar
Khordha
ORISSA |
08249683316
banamali.d@gmail.com |
| DrSeema Jain |
CENTRAL AYURVEDA RESEARCH INSTITUTE |
Out patient Department
Rd. No. 66, Punjabi Bagh West, New Delhi- 110026
West
DELHI |
9911331074
dr_seema_jain@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC,CARI BHUBANESWAR |
Approved |
| IEC,CARI PUNJABIBAGH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AROGYAVARDHINI VATI, Reference: API, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -WARM WATER), Additional Information: (2) Medicine Name: , Reference: PIPPALYADYASAVA, Route: API, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(15), Frequency: ml, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -WATER | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Eat freshly prepared food
Eat only when hungry and after evacuation of Mala (waste products).
Take oil free diet.
Low glycemic food:yava mixed wheat flour, Red rice, barley, Rice (minimum 1 year old)
Fibrous food and vegetables:Parval, Karvellaka, Papaya, Pumpkin,Waterguard (Lauki), RibedGuard, Palaka, Methi, Chaulai, Bitter gourd, snake gourd, drumstick, curry leaves, coriander, ginger, garlic.Legumes- Moong daal,Kulatha, green gram
Fruits: Dadima,,Guava,Chiku,Water melon , Riped Papaya,, Apathya:Avoid reheated & untimely food.
Oily diet. ,Saturated fat, creamy peanut butter.
Food: Packaged snack,chips and nuts, Spicy diet, Baked food,RedMeat,Junk food, Chocolates, Ice creams, Bakery items, Artificial sweeteners, jams
High glycemic food: Wheat flour, Rice (newly harvested), Refined Sugar, white bread, foods made with refined white flour,
Legumes- Black gram,yellow gram,peas,Udad,
Fruits and vegetables:Fruit juice without pulp, Potato, Spinach, Couliflower, Broccoli, Cabbage, beans |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Grade- I&II of Non-alcoholic fatty liver disease as evident fatty infiltration on Ultrasound.
Either sex aged between18- 60 years.
Subjects of non-alcoholic fatty liver disease with their hepatic enzymes <2 times upper normal limit (Normal limits AST 5-40U/L and ALT 7-56U/L).
Willing to provide written consent and able to participate for 4 months in the study.
|
|
| ExclusionCriteria |
| Details |
H/o habitual consumption of alcohol intake of >20g/day for women,>40g/day for men
Any other identified cause of chronic liver disease
The use of medication which would cause non-alcoholic fatty liver - disease e.g. tamoxifen
Already taking supplementary medicine for NAFLD
On anticoagulants (antiplatelet aggregators are permitted)
Past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
Symptomatic patients with clinical evidence of congestive cardiac failure.
Subjects with concurrent Renal Dysfunction (defined as S. creatinine> 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
Uncontrolled Diabetes Mellitus (HbA1C>8)
Known cases of HIV and AIDS, malignancy, Hepatitis B
Subjects participated in any other clinical trial.
Women who are planning for conception / pregnant or lactating.Any other condition which the P.I. thinks may jeopardize the study.
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the change in fibroscan score (Kpa) and CAP value (Kpa) or MRI-PDFF |
Baseline& 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess changes in ALT, AST, Serum bilirubin, Total proteins & Alkaline Phosphatase
Changes in Lipid profile
Changes in HbA1C
Change in BMI
To measure change in Fatty Liver Index
To assess any biological intolerability or adverse events during the trial period
|
Baseline, 90th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/02/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Protocol article published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLDNon-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLD The main goals of treatment are to improve steatosis and to prevent progression of the disease. Intense lifestyle modification and treatment of the risk factors are the cornerstones of disease management. Ayurveda is a holistic science that give prime importance to diet and regimen in maintenance of health and prevention of disease. The aetio-pathogenesis of NAFLD points toMedodhatuDushti, DhatwagniMandyawith or withoutconcurrentRakta Dhatu Dushti. Liver is considered as the seat of DhatwagniPaka and any disease afflicting liver or Rakta will produce DhatwagniMandyain the level of Mamsa and Medas. Considering this, two drugs with action on liver and Medashas been selected for this study. Arogyavardhini Vati(AVR) is a Kharaliya Rasaushadhi (formulations containing metallominerals and mercurials) used for the treatment of different types of Jvara (fever), Kushtha (skin disorders), Medoroga (obesity), and other Yakritvikara (liver disorders)[i]. It has been described in the 13th-century text by Rasa Vagbhata[ii]. Previous study suggests the role of AVR in acute viral hepatitis and possesses significant effects on cytoprotection and recovery of the liver function[iii] and hepatoprotective effect against CCl4-induced liver injury[iv]. Pippalyadyasava contains drugs which are predominantly Katu and Tikta in Rasa (taste), Laghu and Ruksha in Guna(property), Katuin VipakaandUshna in Virya (potency). They mainly act as Deepana and Pachana and thus correct the Agni Mandya |