| CTRI Number |
CTRI/2025/04/084778 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of panchshirish agad ghan vati and panchshirish agad ghan vati with phalatrikadi kwath ghan vati,
in alcoholic fatty liver disease [garavisha janya yakrut vikar] patients .
|
|
Scientific Title of Study
|
Comparative Clinical Study On Phaltrikadikwath Ghan Vati with and without Panchshirisha Agad Ghan Vati on Garavisha Janya Yakrut Vikara w.s.r. 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 |
Anupam Saini |
| Designation |
MD Scholar of Agad Tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,department of Agad Tantra near, Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9928645015 |
| Fax |
|
| Email |
drjpsaini02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VdAmol S Kadu |
| Designation |
Assistant Professor at Department of Agad Tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,Department of Agad Tantra,Room no. 207, near Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9834366502 |
| Fax |
|
| Email |
dramolkaduayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupam Saini |
| Designation |
MD Scholar of Agad Tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,Department of Agad Tantra, near Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9928645015 |
| Fax |
|
| Email |
drjpsaini02@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, near Jorawar Singh Gate Amer Road Jaipur, Rajasthan, India ,pincode 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda jaipur |
| Address |
National Institute of Ayurveda, near Jorawar Singh Gate Amer Road Jaipur, Rajasthan, India ,pincode 302002 |
| Type of Sponsor |
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 |
| Dr Anupam Saini |
National Institute of Ayurveda |
Near jorawar Singh Gate Amer Road jaipur
Jaipur
RAJASTHAN |
9928645015
drjpsaini02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K700||Alcoholic fatty liver. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phaltrikadikwath Ghan Vati , Reference: Chakradatta” vaidya prabha” with hindi commentary, commented by dr indradev tripathi, ch. 8/7 p.n. 79 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchshirish agad Ghan vati, Reference: Charak chikitsasthan Ch.23/218 p. no.139,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18 to 60 years in either sex
Patient having signs, symptoms of Garavisha (Alcohol) Janya Yakrut Vikara
with deranged LFT and USG showing changes of fatty liver disease grade-1 &
grade-2
Follow up cases of Garavisha janya yakrut vikara w.s.r. to Alcoholic fatty liver Disease |
|
| ExclusionCriteria |
| Details |
• Patients of fatty liver disease with severe complications e.g. Fatty liver
disease grade -3, Cirrhosis, Carcinoma, End stage liver disease, Septicaemia,
etc.
• Patients with other serious health issues
• Known cases of Viral Hepatitis
• Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical improvement in sign, symptoms of Garavisha
janya yakrut vikara. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective parameters |
45 days |
|
|
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)
|
01/06/2025 |
| 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="1"
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
|
Ayurvedic Literature has Vast Reference of Formulations indicated for Clinical Conditions Similar to Alcoholic Fatty Liver Disease. on the Basis of those references, " phaltrikadi kwath Ghan vati and Panch shirirsh Agad Ghan vati have been Selected for the Present Clinical Study. Taking into consideration of Garavisha (Alcohol) as etiological
factor for Alcoholic fatty liver disease, Panchashirisha Agad Ghan Vati is
selected which is best in treating any Visha Janya conditions. Phaltrikadikwath Ghan Vati is a most common and already tested preparation for
the treatment of liver disorders and it is a purely herbal preparation, hence very
much safe and more effective and acts as a vyadhi pratyanik medicine. |