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CTRI Number  CTRI/2024/11/077253 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To Understand the Etiopathology of Jaundice Through changes in Liver Function Test  
Scientific Title of Study   An Approach to Etiopathological Diagnostic Study on Koshtashakashrita Kamala of Raktavaha Srotodushti Through Liver Function Test 
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 Desai Ravina Chandubhai 
Designation  M D Scholar Roga Nidan and Vikruthi Vijnana 
Affiliation  Government Ayurvedic Medical College 
Address  Government Ayurvedic Medical College, Dhanvantri Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9512895212  
Fax    
Email  desairavina2210@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudeesha J 
Designation  Assistant Professor 
Affiliation  Government Ayurvedic Medical College 
Address  Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9481818631  
Fax    
Email  drsudeeshshetty@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudeesha J 
Designation  Assistant Professor 
Affiliation  Government Ayurvedic Medical College 
Address  Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9481818631  
Fax    
Email  drsudeeshshetty@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Medical College, Dhanvantri Road, Bangalore,Karnataka,India-560009 
 
Primary Sponsor  
Name  Government Ayurvedic Medical College 
Address  Government Ayurvedic Medical College, Dhanvantri Road, Bangalore, Karnataka-560009 
Type of Sponsor  Research institution and hospital 
 
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 Desai Ravina Chandubhai  Government Ayurvedic Medical College  Opd No- 7A ,Department of Roganidan, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore,Karnataka,India-560009
Bangalore
KARNATAKA 
9512895212

desairavina2210@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Ayurvedic Medical College, Dhanvantri Road, Bangalore-560009  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K769||Liver disease, unspecified. Ayurveda Condition: KAMALA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients between age group of 18 to 70 years
Patients who satisfied the diagnostic criteria 
 
ExclusionCriteria 
Details  Patients suffering from other systemic diseases like Diabetes mellitus, hypertension, HIV, TB etc.
2. Patients suffering from secondary disorders of liver like liver cirrhosis, hyperbilirubinemia due to autoimmune disorders etc.
3. Pregnant ladies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Understand the Etiopathogenesis of Koshtashakashrita Kamala Through Liver Function Test  Nil 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate the changes of Liver Function Test in Koshtashakashrita Kamala   Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/12/2024 
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="5"
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  
Kamala is a Pittaja Nanatmaja Vyadhi, comes under Raktapradoshaja Vikara. If Rakta get vitiated by the doshas then it leads to Raktapradoshaja Vikara like kamala. Yakrit, Pleeha and Raktavaha Dhamani are considered as Moolasthana of Raktavaha srotas . In today’s era, the changing life style and eating pattern like Viruddhaahara, Asatmya bhojana, Vidahi annapana etc, causes Vikruti of Pitta Dosha. Due to ashraya-ashrayi bhava does the prakopa of Rakta , which makes them to affect with Raktavaha Srotodushti and does the Dagdhata of Rakta and Mamsa resulting in the manifestation of kamala.
In koshtashakhashrita kamala due to Swatantra Nidana Pitta Dosha get vitiated mainly the Ranjaka Pitta present in Raktadi dhatu and Koshta get vitiated and produces the lakshanas like Haridra Netra,Nakha,Twaka,Mutra,Anana etc. These symptoms are similar to Jaundice. 
Jaundice is characterized by yellowish discoloration of body tissue resulting from the accumulation of excess bilirubin. Prevalence of Jaundice Acc. to American Roentgen Ray Society image of Jaundice epidemiology and demographics is approximately 40%.
Liver is a dual organ having both secretory and excretory functions , Liver perform various functions in maintaining homeostasis and health. These functions include the synthesis of albumin, certain enzymes, bile and its constituents, metabolism of bilirubin etc. When the liver is diseased, one or more of its functions are impaired result in elevated levels of its constituents.
Here an attempt is made to understand the Vishesha samprapti and Diagnosis of Koshtashakhashrita kamala and to know the Role of Parinama bhavas of Raktavaha Srotodushti and to assess the changes in Liver Function Test.
 
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