| CTRI Number |
CTRI/2025/09/095162 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Anatomical study of Hepatosplenomegaly |
|
Scientific Title of Study
|
A Clinico Anatomical Study of Raktavaha Srotomula WSR to Hepatosplenomegaly |
| 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 Anil Kumar |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Department of Rachana Sharir
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow
Lucknow UTTAR PRADESH 226004 India |
| Phone |
9795719638 |
| Fax |
|
| Email |
anl38676@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Department of Rachana Sharir
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow
Lucknow UTTAR PRADESH 226004 India |
| Phone |
9935039819 |
| Fax |
|
| Email |
drarvind1973@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Department of Rachana Sharir
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow
Lucknow UTTAR PRADESH 226004 India |
| Phone |
9795719638 |
| Fax |
|
| Email |
anl38676@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.G. Department of Rachana Sharir
State Ayurvedic College and Hospital, Lucknow
Tulsidas Marg,
Tudiya Ganj,
Lucknow |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004 |
| 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 Anil Kumar |
State Ayurvedic College and Hospital Lucknow |
Room no. 6
Ground floor
Department of Kayachikitsa Lucknow UTTAR PRADESH |
9795719638
anl38676@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PLIHAROGAH, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having the symptoms of raktavaha srotodushti associated with hepatosplenomegaly- Shyavangta (cynosis), Jwara (fever), dah (burning sensation), panduta (anemia), kamla (Juandice), pleeha (splenomegaly), skin disorders etc.Patient having S.Bilirublin less than 10mg/dL will be taken. |
|
| ExclusionCriteria |
| Details |
a. Cases will not be taken under the 18 year and above the 60 years age group.
b. The case will not be taken of those who are suffering from cancer diseases or malignancy.
c. Patients will not be taken of that who are suffering from any genetic disorder.
d. Patient having S.Bilirubin greater than 10 will not be taken |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there is significant correlation between ayurvedic concept of Raktavaha Srotomool Dusti with sign and symptoms of hepatospleenomegaly. |
The data will be collected once only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is no correlation between ayurvedic concept of Raktavaha Srotomool Dusti with sign & symptoms of hepatospleenomegaly |
Data will be collected once only |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
30/09/2025 |
| 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="0" Months="6" 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
|
The proposed clinical study titled “A Clinico-Anatomical Study of Raktavaha Srotomoola with Special Reference to Hepatosplenomegaly” is designed to explore the Ayurvedic and modern understanding of hepatosplenomegaly, correlating classical concepts of Raktavaha Srotas with clinical, anatomical, and pathological findings.
In Ayurveda, health is maintained by the equilibrium of dosha, dhatu, and mala, and their circulation through srotas (channels). Among them, Raktavaha Srotas play a vital role in the transport and transformation of blood. Classical texts identify Yakrit (liver) and Pleeha (spleen) as its roots (moola), while Sushruta additionally includes Raktavahi Dhamanis. Disorders of these channels (Raktavaha Srotodushti) manifest as hepatosplenomegaly, jaundice, anemia, splenic enlargement, and skin disorders. With sedentary lifestyles, poor diet, and rising metabolic diseases, the incidence of liver and spleen disorders such as NAFLD, chronic hepatitis, and portal hypertension is increasing globally, making this study highly relevant.
The research will be conducted under three major components:
-
Literary Study – Comprehensive review of Vedas, Samhitas (Charaka, Sushruta, Kashyapa, Sharangadhara), and commentaries, along with modern medical literature to establish a comparative framework of Raktavaha Srotas, their moola, functions, and disorders.
-
Cadaveric Study – Dissection-based exploration of liver and spleen structures to establish anatomical correlations with Ayurvedic concepts of Raktavaha Srotomoola.
-
Clinical Study – A minimum of 40 patients (age 18–60 years) presenting with clinical features of hepatosplenomegaly and symptoms of Raktavaha Srotodushti (jwara, panduta, kamla, pleeha vriddhi, shyavata, etc.) will be enrolled from OPD/IPD of State Ayurvedic College, Lucknow. Modern investigations including ultrasonography (USG), liver function tests (SGOT, SGPT, alkaline phosphatase, serum bilirubin) will be employed to confirm diagnosis and evaluate disease status.
Inclusion criteria: patients aged 18–60 years with hepatosplenomegaly and serum bilirubin <10 mg/dL.
Exclusion criteria: malignancy, genetic disorders, patients <18 or >60 years, and serum bilirubin >10 mg/dL.
The aims are:
-
To resolve discrepancies in classical texts regarding the moola of Raktavaha Srotas.
-
To correlate Ayurvedic descriptions of Raktavaha Srotodushti with clinical and anatomical findings of hepatosplenomegaly.
Objectives include compilation of classical and modern references, cadaveric verification, and clinical evaluation with statistical analysis of findings.
This study is expected to provide a holistic framework for understanding hepatosplenomegaly in the light of Ayurveda and modern medicine. It will aid in better diagnosis, interpretation, and management of liver and spleen disorders by integrating traditional concepts with contemporary diagnostic tools. |