| CTRI Number |
CTRI/2026/01/101694 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Evaluate the Role of Ayurvedic Treatment in Liver Cirrhosis |
|
Scientific Title of Study
|
Effect of Ayurvedic Management in Decompensated Liver Cirrhosis an observational single group retrospective study. |
| 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 Ruchi Makwana |
| Designation |
PG Scholar |
| Affiliation |
J.S Ayurved Mahavidhyalaya and P. D. Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kayachikitsa, J.S Ayurved
Mahavidhyalaya,College Road Nadiad 387001. Kheda,Gujarat.
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9499697813 |
| Fax |
|
| Email |
fillory.brakebills418@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nimesh Kachhiapatel |
| Designation |
Associated Professor of Kayachikitsa |
| Affiliation |
J.S Ayurved Mahavidhyalaya and P. D. Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kayachikitsa, J.S Ayurved
Mahavidhyalaya,College Road Nadiad 387001. Kheda,Gujarat.
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9979890381 |
| Fax |
|
| Email |
drnimesh71@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Nimesh Kachhiapatel |
| Designation |
Associated Professor of Kayachikitsa |
| Affiliation |
J.S Ayurved Mahavidhyalaya and P. D. Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kayachikitsa, J.S Ayurved
Mahavidhyalaya,College Road Nadiad 387001. Kheda,Gujarat.
Kheda
GUJARAT
387001
India
Kheda
GUJARAT
387001
India |
| Phone |
9979890381 |
| Fax |
|
| Email |
drnimesh71@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurvedic Hospital |
| Address |
Post Graduate Department of Kayachikitsa, J.S Ayurved
Mahavidhyalaya,College Road Nadiad 387001. Kheda,Gujarat.
Kheda
GUJARAT
387001
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Makwana |
J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurvedic Hospital |
Post Graduate Department of Kayachikitsa, J.S Ayurved
Mahavidhyalaya,College Road Nadiad 387001. Kheda,Gujarat.
Kheda
GUJARAT
387001 India
Kheda
GUJARAT |
09499697813
fillory.brakebills418@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K740||Hepatic fibrosis. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients clinically or radiologically diagnosed with decompensated liver cirrhosis
and complication with ascites.
Laboratory findings with Hyperbilirubinemia.
Received exclusive Ayurveda Management for at least 1 month on IPD bases
and 5 months OPD base follow up.
Complete Medical Records including LFTs and symptoms evaluation available. Patients clinically or radiologically diagnosed with decompensated -liver cirrhosis
and complication with ascites.
Laboratory findings with Hyperbilirubinemia.
Received exclusive Ayurveda Management for at least 1 month on IPD bases
and 5 months OPD base follow up.
Complete Medical Records including LFTs and symptoms evaluation available. |
|
| ExclusionCriteria |
| Details |
Pregnant women
Hepatic cirrhosis due to cardiac causes, inherited metabolic causes.
Other major co – morbities like insulin dependent diabetes mellitus, bleeding
piles, heart disease, renal failure.
Life threatening complications like encephalopathy and excessive gastrointestinal
bleeding.
Incomplete documentation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and find out changes of clinical charecteristic, abdominal girth,urine output and abdominal pain, before and after ayurvedic treatment. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate improvement in key clinical symptoms & signs of the patients
To assess changes in liver function test parameters before & after Ayurveda treatment.
To assess the benefit in survival chances of Decompensated Liver Cirrhosis after taking
long term ayurveda therapy through changes in Child-Pugh grade score. |
6months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2026 |
| 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
|
Decompensated Liver Cirrhosis (DLC) is the advanced and irreversible stage of chronic liver disease
where the liver loses its functional capacity and presents with complications like ascites, jaundice, hepatic encephalopathy, variceal bleeding,
coagulopathy and fluid retention. Liver transplantation is the only definitive treatment in modern medicine, but due to high cost, limited
donor availability and strict eligibility criteria, most patients rely on supportive or palliative care. In Ayurveda, liver disorders are described
under Yakrit Vikara, Kamala, Kumbha Kamala and Jalodara, caused mainly by aggravated Pitta and Rakta leading to progressive liver
dysfunction. Ayurvedic management focuses on Shodhana (mainly Virechana), Samana, Rasayana, Tikshna dravyas, Kshara karma and
dietary regulation including Takra, Dugdha, Yavagu, light and pitta-shamaka ahara along with fluid-salt restriction. This retrospective
observational single-group study aims to evaluate the effect of Ayurvedic management in patients of Decompensated Liver Cirrhosis treated
at P.D. Patel Ayurvedic Hospital. Hospital records from 2021–2025 will be analysed for age, diagnosis, symptoms, treatment details,
laboratory parameters and Child-Pugh score. Improvement in symptoms like ascites, oedema, jaundice, appetite, urine output, abdominal
girth and biochemical markers including bilirubin, albumin, SGPT, SGOT and INR will be assessed before and after treatment. Since there
is a lack of systematically documented evidence regarding Ayurvedic management in advanced liver disorders, this study aims to provide
clinical data and real-world outcomes to support future research and evidence-based practice. It bridges classical Ayurvedic principles with
modern clinical evaluation to assess the efficacy of Shamana–Shodhana therapy in improving survival chances, quality of life and functional
health status in Decompensated Liver Cirrhosis. |