| CTRI Number |
CTRI/2024/07/070476 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of Rohitakadi vati and Pippali vati orally after Virechana in Non alcoholic fatty liver disease |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the efficacy of Rohitakadi vati and Pippali vati orally after Virechana in Non-alcoholic fatty liver disease. |
| 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 Harshitha K S |
| Designation |
Assistant Professor and Consultant Physician (Ayurveda) |
| Affiliation |
Government Ayurveda Medical College, Hospital and Research centre, Mysuru, Karnataka |
| Address |
Sri kalabyraweshwara Ayurveda Medical college, Hospital and Research centre, Bengaluru, Karnataka
Government Ayurveda medical college,hospital and research centre, Mysuru Karnataka
Mysore
KARNATAKA
560040
India |
| Phone |
7022028281 |
| Fax |
|
| Email |
harshithasathyakumar94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda Medical College, Mysuru |
| Address |
OPD 10, Department of Kayachikitsa,
Government Ayurveda medical college
Sayyaji Rao Road
Mysuru-01
Mysore
KARNATAKA
57001
India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshitha K S |
| Designation |
Assistant Professor and Consultant Physician (Ayu) |
| Affiliation |
Sri Kalabyraveshwara swamy Ayurveda Medical college, Hospital and Research centre |
| Address |
OPD 2, Department ofKayachikitsa
Sri Kalabyraveshwara swamy Ayurveda Medical college, Hospital and Research centre, 10,Pipeline road
Vijayanagar 2nd stage, RPC layout
Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
7022028281 |
| Fax |
|
| Email |
harshithasathyakumar94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyravshwara Swamy Ayurveda medical college, hospital and research centre, 10, Pipeline road, Vijanagar 2nd stage, RPC layout, Bengaluru-560104 |
|
|
Primary Sponsor
|
| Name |
Dr Harshitha K, S |
| Address |
Sri Kalabyraveshwara Ayurveda medical college. Hospital and research centre |
| Type of Sponsor |
Other [SELF (Funded)] |
|
|
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 |
| Dr Harshitha K S |
Goverment Ayurveda medical college, Mysuru |
OPD10, Kayachikitsa, Government Ayurveda medical college 8M72+VJ5, Visvesvaraya Cir, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 570001
Mysore
KARNATAKA |
07022028281
harshithasathyakumar94@gmail.com |
| Dr Harshitha K S |
Sri Kalabyraveshwara Swami Ayurveda medical College, Hospital and Research centre |
OPD 2
Department of Kayachikitsa, Sri Kalabyraveshwara Swamy Ayurveda Hospital, College and Research centre
10, Pipeline Rd, Vijayanagar 2nd stage
Hampi Nagar, RPC Layout, Vijayanagar
Bengaluru
Karnataka 560104
Bangalore
KARNATAKA |
07022028281
harshithasathyakumar94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitonal Ethics Committee, Sri Kalabyraveshwara Ayurveda medical college, hospital and research centre |
Approved |
| Institutioanl Ethics committee Government Ayurveda medical collegeM ysuru |
Approved |
|
|
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: Rohithakadi Vati, Reference: Bhaishajya rathnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Karavellaka swarasa), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippali Vati, Reference: Bhaishajya Rathnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Luke warm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinical signs and symptoms suggesting of NAFLD/Yaká¹›t Roga, that is, pain in right upper quadrant/epigastric region of the abdomen, feeling of nausea, and vomiting, loss of appetite, burning sensation in the abdomen
2.Ultrasonography (USG) abdomen/or other scanning modalities such as contrast-enhanced computed tomography (CECT) abdomen showing fatty infiltration of the liver. USG findings suggestive of fatty liver grade 1, 2, and 3
3.Biochemical: Liver function tests showing raised alanine transaminases (ALT) levels approximately more than 1.5 times the normal limits with/without raised lipid profile and fasting blood glucose levels within normal limits.
|
|
| ExclusionCriteria |
| Details |
1.Patients in whom alcohol intake exceeded 20 g/day (history of alcohol intake was taken separately from the patients and close relatives)
2.Patients having fasting blood sugar (FBS) ≥200 mg/dl and postprandial blood sugar (PPBS) ≥250 mg/dl, despite taking oral hypoglycemic agents, Stage II hypertension, i.e.,systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100 mmHg, despite taking antihypertensive drugs
3.Patients with complications of metabolic syndrome such as a cerebrovascular accident, myocardial infarction, chronic kidney disease, suffering from cirrhosis, ascites, variceal hemorrhage, coagulopathy, hepatorenal syndrome, consuming hepatotoxic medicines, alcohol or other narcotic substances.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms of Non alcoholic fatty liver disease- Nausea,Pain abdomen, Burning sensation inabdomen, belching, flatulence, constipation , Changes in Chronic liver disease Questionnaire |
1st assessment-Before treatment (0th day)
2nd assessment- During treatment(31st day)
3rd assessment-(61st day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in USG Abdomen, Changes in SGOT,SGPT, Changes in Lipid profile, Changes in BMI |
1st assessment-Before treatment (0th day)
2nd assessment- During treatment(31st day)
3rd assessment-(61st day) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/06/2025 |
| 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="3"
Months="6"
Days="0" |
|
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
|
Over the past couple of decades, it has become increasingly clear that nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are the significant causes of liver disease. NAFLD is now the most prevalent form of chronic liver disease, affecting 20%–30% of the general population.NAFLD is a leding cause of liver disease worldwide. The estimated global incidence of NAFLD is 47 cases per 1,000 population and is higher among males(40%) than females(32%) Within the next 10 years, it is expected to become the leading cause of liver pathology, liver failure, and indication for liver transplantation. The prevalence of fatty liver disease in India is found to be as high as 24%,which is similar to that reported in some of the Western countries, where it correlates with the prevalence of obesity. Starting from a simple steatosis, NAFLD can proceed to steatohepatitis and fibrosis. Cirrhosis and/or hepatic carcinoma can be its terminal complication.
The aim of this study is to compare the efficacy of Rohitakadi vati and Pippali vati orally after virechana in patients of Non alcoholic fatty liver disease. 200 subjects satisfying diagnosis and inclusion criteria will be divided in to 2 groups of 100 subjects each, Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in their symptoms, BMI, USG abdomen and also their quality of life will be assessed based on chronic liver disease questionnaire. |