| CTRI Number |
CTRI/2024/03/064268 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An ayurvedic management of Jalodara-ascites |
|
Scientific Title of Study
|
AN AYURVEDIC MANAGEMENT OF JALODARA HEPATIC CIRRHOSIS COMPLICATED WITH ASCITES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHaripriya Panjabi |
| Designation |
PhD scholar- Associate Professor |
| Affiliation |
|
| Address |
J S Ayurved Mahavidyalaya College Road Nadiad
J. S Ayurved Mahavidyalaya College Road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9723569239 |
| Fax |
|
| Email |
priyapanjabi1608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish V Patel |
| Designation |
HOD and Professor of kayachikitsa department |
| Affiliation |
J S Ayurveda Mahavidhyalaya and PD Patel Ayurveda Hospital |
| Address |
J S Ayurveda Mahavidhyalaya college road Nadiad
J S Ayurveda Mahavidhyalay college road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish V Patel |
| Designation |
HOD and Professor of kayachikitsa department |
| Affiliation |
J S Ayurveda Mahavidhyalaya and PD Patel Ayurveda Hospital |
| Address |
J S Ayurveda Mahavidhyalaya college road Nadiad
J S Ayurveda Mahavidhyalay college road Nadiad
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sunder Ayurveda pharmacy Of J S Ayurveda mahavidyalaya Nadiad |
|
|
Primary Sponsor
|
| Name |
J S ayurved mahavidyalaya |
| Address |
J S Ayurved mahavidyalaya college road nadiad |
| Type of Sponsor |
Private 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 Haripriya Panjabi |
J S Ayurved mahavidyalaya |
J S Ayurved mahavidyalaya and P D Patel ayurvedic hospital
college road nadiad 387001
Kheda
GUJARAT |
9723569239
priyapanjabi1608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituational ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K77||Liver disorders in diseases classified elsewhere. Ayurveda Condition: JALODARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: charaka samhita, Procedure details: 14 th day mrudu virechana will be done by katuki churna as per the kostha (3-6gm) with milk)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pippali churna , Reference: charaka samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: pipali vardhmana karmena upto 5gm 5 days then after tappring upto 1 gm with milk(2) Medicine Name: bhumiamalki + sharpunkka , Reference: bhavprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: (3) Medicine Name: , Reference: shwata parpati, Route: sidhyoga samgraha, Dosage Form: Churna/ Powder, Dose: 9(500), Frequency: mg, Bhaishajya Kal: bd, Duration: Abhakta, anupAna/sahapAna: No, Additional Information: milk(4) Medicine Name: , Reference: punarnavadi kwatha, Route: sharngdhara, Dosage Form: Churna/ Powder, Dose: 26(40), Frequency: ml, Bhaishajya Kal: bd, Duration: Abhakta, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: , Reference: bhrungraja churna, Route: bhavprakasha, Dosage Form: Churna/ Powder, Dose: 9(3), Frequency: g, Bhaishajya Kal: bd, Duration: Abhakt, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Abnormal liver function tests hypoalbuminemia altered A G ratio raised SGPT and SGOT
Confirmation of ascites due to hepatic cirrhosis with ultrasound scans of abdomen
Alcoholic and non-alcoholic both patients will be included
|
|
| ExclusionCriteria |
| Details |
Hepatic Cirrhosis due to cardiac causes, inherited metabolic causes Haemochromatosis and Wilson’s disease
Recent ≤ 3 month life-threatening complications like Encephalopathy and excessive gastrointestinal bleeding) and other major co-morbidities like Insulin-dependent Diabetes Mellitus manifest heart diseases, renal failure
Female patients having pregnancy post-delivery period or lactation period
Patients who are taking any psychiatric medicines will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the hetu samprapti and lakshana samuccaya of Jalodara as well as hepatic cirrhosis Also to study and observe the efficacy and effectiveness of Ayurvedic treatment in the management of Jalodara hepatic cirrhosis complicated with ascites |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the changes in the laboratory investigations especially liver function tests Serum albumin serum bilirubin total direct and indirect serum protein prothrombin time SGOT and SGPT To find out the changes in Child-Pugh grade score |
16 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
25/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
will publish shortly |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
single arm clinical study sample sizeb 30 to asses the clinical menifestation of ascitis complicated with hepatic chirosis along with liver function test before and after clinical study assesment done with child pugh test |