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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
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:

  1. 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.

  2. Cadaveric Study – Dissection-based exploration of liver and spleen structures to establish anatomical correlations with Ayurvedic concepts of Raktavaha Srotomoola.

  3. 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.

 
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