| CTRI Number |
CTRI/2026/01/102513 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Ayurvedic Understanding, Clinical Profile, and Treatment Outcomes in Liver and Biliary Cancers and a Pilot Trial on Ayurvedic Management of Liver Cancer |
|
Scientific Title of Study
|
A Prospective Observational Cohort Study on Clinical Presentation, Ayurvedic Understanding, Patient Intentions, and Treatment outcomes in Hepatobiliary Cancers and A Clinical Pilot study to assess the outcomes of Ayurveda Interventions in Hepatocellular Carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jassim Rahiman K |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
Department of Kayachikitsa, All India Institute of Ayurveda (AIIA), Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
8593884668 |
| Fax |
|
| Email |
jassirhmn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V G Huddar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
Department of Kayachikitsa, All India Institute of Ayurveda (AIIA), Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9986697942 |
| Fax |
|
| Email |
dr.vghuddar@aiia.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V G Huddar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
Department of Kayachikitsa, All India Institute of Ayurveda (AIIA), Gautam Puri, Mathura Road, Sarita Vihar, New Delhi
DELHI
110076
India |
| Phone |
9986697942 |
| Fax |
|
| Email |
dr.vghuddar@aiia.gov.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda (AIIA), Gautam Puri, Mathura Road, Sarita Vihar, New Delhi - 110076
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda (AIIA) |
| Address |
All India Institute of Ayurveda (AIIA), Gautam Puri, Mathura Road, Sarita Vihar, New Delhi - 110076
|
| 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 Jassim Rahiman K |
All India Institute of Ayurveda (AIIA) |
OPD 109 C Centre for Integrative Oncology (CIO) and OPD 2, OPD 5 Department of Kayachikitsa, Hospital Block
South
DELHI |
8593884668
jassirhmn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Ayurveda (AIIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C22||Malignant neoplasm of liver and intrahepatic bile ducts. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
PART I OBSERVATIONAL STUDY
1 Participants aged ten years to seventy years.
2 Patients diagnosed with any type of cancer of the hepatobiliary system, including liver, intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of Vater. Cancer site (topography) and type, behavior, and grade (morphology) will be recorded as per ICD-O-3 (International Classification of Diseases for Oncology, Third Edition).
3 ECOG performance status between zero and two.
4 Patients who are receiving or planning to receive Ayurveda-based cancer care at the tertiary care hospital, either before, during or after conventional treatments such as surgery, chemotherapy or radiotherapy.
5 Availability of essential medical records, including histopathology reports, staging details and prior treatment history, to ensure accurate disease classification and enable adjusted analyses.
PART II: CLINICAL PILOT STUDY
1 Participants aged 18 years and above.
2 Diagnosed cases of hepatocellular carcinoma.
3 Disease staging as per the Barcelona Clinic Liver Cancer (BCLC) Staging System, including Stage B, Stage C, and Stage D.
4 Patients who have been advised conventional cancer therapies but have declined such treatments after adequate counselling.
5 ECOG performance status between zero and two.
6 Provision of written informed consent prior to participation.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
PART I OBSERVATIONAL STUDY
1 Participants who are unable to complete patient reported outcomes due to severe cognitive impairment, psychiatric illness, absence of validated language tools, or critical illness, as per the judgment of the investigator.
2 Anticipated inability to complete six month follow-up (such as relocation, hospice care, logistic barriers).
3 Concurrent enrollment in another interventional study is likely to influence symptom or QoL outcomes.
4 Pregnant or breastfeeding when Ayurveda exposures or procedures may be contraindicated.
5 Patients unwilling or unable to provide informed consent or adhere to follow-up assessments.
PART II CLINICAL PILOT STUDY
1 Prior systemic therapy, radiotherapy, or surgery for hepatocellular carcinoma in the last two months.
2 ECOG performance status greater than or equal to three.
3 Severe uncontrolled comorbidities.
4 Pregnant or lactating women.
5 Inability/unwillingness to consent or comply.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To document clinical presentation, Ayurvedic understanding, patient intentions to opt for Ayurveda, therapeutic practices, and outcomes through quality-of-life assessment in hepatobiliary cancer patients through FACT-Hep and EORTC QLQ-C30 over six months.
2. To evaluate preliminary clinical outcomes, through protocolized ayurvedic interventions in hepatocellular carcinoma (HCC) through changes in Albumin-Bilirubin (ALBI) score over two months. |
Observational: Hepatobiliary cohort study
Baseline, 2 months, 4 months, 6 months
HCC pilot
Baseline, 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the safety, tolerability & patient compliance with Ayurvedic interventions.
2 To observe & document adverse drug reactions or adverse events, if any.
3 To assess the functional status of hepatobiliary cancer patients using the ECOG Performance status.
4 To assess preliminary outcomes of Ayurveda interventions in hepatocellular carcinoma through changes in liver function tests, quality-of-life assessment (EORTC QLQ HCC 18) & ECOG performance status.
|
Observational Hepatobiliary cohort study
Baseline, 2 months, 4 months, 6 months
HCC pilot
Baseline, 1 month, 2 months |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
13/02/2026 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a single-centre, two-phase study conducted at a tertiary-care
Ayurveda hospital, AIIA in New Delhi to evaluate the role of Ayurveda in the
management of hepatobiliary cancers, including hepatocellular carcinoma,
cholangiocarcinoma, and gallbladder cancer.
Part I is a prospective observational cohort
study enrolling patients with hepatobiliary cancers who will be followed for
six months. The study will document sociodemographic and clinical
characteristics, cancer type and stage, prior and concurrent conventional
treatments, and detailed Ayurvedic assessments. The primary outcome is change
in quality of life, with secondary outcomes including performance status,
symptom burden, treatment adherence, and safety.
Part II is a single-arm clinical pilot study
involving patients with hepatocellular carcinoma who have declined or are not
receiving conventional therapy. Participants will receive protocol-based
Ayurvedic interventions for two months. The primary outcome is change in liver
functional reserve assessed using the Albumin–Bilirubin score, with secondary
outcomes including liver function tests, quality of life, performance status,
and safety.
Data will be analyzed using descriptive and
paired inferential statistics, with multivariate analyses and principal
component analysis to explore associations between multimodal Ayurvedic
treatment patterns and clinical outcomes, focusing on feasibility, safety, and
effect-size estimation. |