| CTRI Number |
CTRI/2025/03/082695 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Non Alcoholic Fatty Liver Disease with the use of Abhayadi Kwatha |
|
Scientific Title of Study
|
Clinical Evaluation of Abhayadi Kwatha in the Management of Non Alcoholic Fatty Liver Disorder(NAFLD)-An Open Labelled Clinical Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhavi Jani |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD No.4 Kayachikitsa Department, Government Akhandanand College, Bhadra, Ahmedabad, Gujarat ,380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8320059249 |
| Fax |
|
| Email |
vaibhavijani1212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika Soni |
| Designation |
Associate Professor |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD No.4 Kayachikitsa Department, Government Akhandanand College, Bhadra, Ahmedabad, Gujarat ,380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8209199183 |
| Fax |
|
| Email |
ayursoni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhavi Jani |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Government Akhandanand Ayurved College and Hospital |
| Address |
OPD No.4 Kayachikitsa Department, Government Akhandanand College, Bhadra, Ahmedabad, Gujarat ,380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8320059249 |
| Fax |
|
| Email |
vaibhavijani1212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College, Ahmedabad-380001,Gujarat |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College |
| Address |
OPD NO 4, Department of Kayachikitsa, Government Akhandanand Ayurveda College, Ahmedabad-380001,Gujarat |
| Type of Sponsor |
Other [Government 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 |
| Vaibhavi Jani |
Government Akhandanand Ayurveda College and Hospital |
OPD No.4 Kayachikitsa Department, Government Akhandanand College, Bhadra, Ahmedabad, Gujarat ,380001
Ahmadabad
GUJARAT |
08320059249
vaibhavijani1212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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: YAKRUDDALYUDARAH, (2) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhayadi Kwatha, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of age group, above 18 years and below 60 years.
Both freshly detected and previously diagnosed cases of NAFLD.
USG findings suggestive of NAFLD grade 1,2 and 3.
|
|
| ExclusionCriteria |
| Details |
Patient aged below 18 years and above 60 years.
Pregnant women and lactating women.
Uncontrolled Diabetes with (HBA1C greater than 7%)
Complications of Metabolic Syndrome like Cardiovascular disease, MI, Chronic Kidney Disease.
Consuming Hepatotoxic drugs, Narcotic drugs and consuming Alcohol.
Cirrhosis, Ascites, Variceal Hemorrhage, Hepato-Renal Syndrome.
HIV, Malignancies, T.B.
Patient with any acute or chronic systemic illness and with acute infectious or inflammatory conditions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the hematological parameters of LFT(Including ALT, AST, ALP, GGT, S. Bilirubin, PT, INR, Total protein and albumin) and changes in USG whole abdomen |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of Non Alcoholic Fatty Liver Diseases |
Day 15
Day 30
Day 45
Day 60 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/04/2025 |
| 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="8"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Non-alcoholic
fatty liver disease (NAFLD) is fat accumulation in the liver due to increasing
sedentary lifestyles and changing dietary patterns. NAFLD includes spectrum of progressive
liver disease ranging from fatty infiltration alone (steatosis) to fatty
infiltration with inflammation (non-alcoholic steatohepatitis, NASH) and may
progress to liver cirrhosis and primary liver cancer. NAFLD is
frequently asymptomatic, although it may be associated with: Dyspepsia,
Fatigue, Malaise, and Right upper quadrant discomfort.
NAFLD is
commonly diagnosed as incidental biochemical abnormality during routine blood
tests and during USG or CT Scan of the abdomen. No pharmacology agents are
currently available for NAFLD, several Empirical treatment strategies such as
dietary restriction, physical exercises and weight reduction forms the first
line of treatment. Hence there is search for alternative treatment modalities
in other systems of medicine which is safe and cost effective. DIAGNOSTIC CRITERIA:
The patient will be diagnosed based on Clinical features (Dyspepsia, Fatigue,
Malaise, and Right upper quadrant discomfort.) and Radiological(USG)findings and laboratories investigations(LFT)
Dyspepsia includes Epigastric pain, Regurgitation, Nausea, Vomiting,
Belching and Dysphagia
1.
Ultrasonography
of abdomen which shows
bright liver due to hyperechogenicity.
2.
BLOOD
REPORTS: That includes
LFT with mild to moderately elevated serum
transaminase (ALT:
AST) and nonspecific elevation of
gamma-glutamyl transferase. Present study is being planned to evaluate the study on NAFLD with drug Abhayadi Kwatha . The sample size is 30 patients.Abhayadi Kwatha will be given in the dose of 40ml twice a day empty stomach Study duration is 60 days. Study design is an Open Labelled Clinical Trial.
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