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CTRI Number  CTRI/2024/11/077204 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 27/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of conventional medicines in liver disorders with blood purifiers as mentioned in Ayurveda 
Scientific Title of Study   A randomized comparative trial with Rakta Prasadak Ausadha in Yakrita Dushti for validation of Garbhasya yakratpleehano shonitajo 
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. Ritika 
Designation  MD Scholar (Rachana Sharir) 
Affiliation  National Institute of Ayurveda 
Address  Department of Rachana Sharir National Institute of Ayurveda Jaipur, Rajasthan Pin code - 302002
National Institute of Ayurveda Jaipur, Rajasthan Pin code - 302002
Jaipur
RAJASTHAN
302002
India 
Phone  8619346220  
Fax    
Email  ritikakaswa830@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Neha Udainiya 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Rachana Sharir National Institute of Ayurveda Jaipur, Rajasthan pin code 302002
National Institute of Ayurveda Jaipur, Rajasthan pin code 302002
Jaipur
RAJASTHAN
302002
India 
Phone  8607429931  
Fax    
Email  neha.rs@nia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Neha Udainiya 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Rachana Sharir National Institute of Ayurveda Jaipur, Rajasthan pin code 302002
National Institute of Ayurveda Jaipur, Rajasthan pin code 302002

RAJASTHAN
302002
India 
Phone  8607429931  
Fax    
Email  neha.rs@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur, Rajasthan India pin code 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Jaipur, Rajasthan pin code 302002 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Ritika  National Institute of Ayurveda, Jaipur  OPD No. 3 SSBH Department of Rachana Sharir National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN 
8619346220

ritikakaswa830@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda  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: RAKTAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: SARIVAGHAN VATI, Reference: PRIYANIGHANTU, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: ROHITAKGHAN VATI, Reference: BHAVPRAKASH NIGHANTU, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient with already known case of any liver disorders (pre-hepatic and hepatic cause) with deranged LFT (liver function test) values falling in the range.
2. Patient of either sex having age between of 18 to 50 yrs.
3. Patients who are willing to sign consent form for the trial 
 
ExclusionCriteria 
Details  i. Patients below age of 18 yrs and above 50 yrs.
ii.Patient with k/c/o uncontrolled Diabetes, Hypertension, Carcinoma, etc.
iii. Patients with post hepatic conditions such as common bile duct obstruction, liver cirrhosis, bile duct tumor, carcinoma of pancreas head, etc.
iv. Patient participated in any clinical trial with in last six months.
V. Pregnant or lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
CLASSICAL SIGN AND SYMPTOMS OF YAKRITA DUSHTI AS PER SAMHITA  after 4week 
 
Secondary Outcome  
Outcome  TimePoints 
Based upon the changes in liver function test, CBC, TEC  15 days 
 
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   Phase 2 
Date of First Enrollment (India)   01/12/2024 
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="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   Purpose of study:
Liver disease accounts for 2 million deaths annually(cirrhosis, viral hepatitis, and liver cancer) and is responsible for 4% of all deaths (1 out of every 25 deaths worldwide); approximately two-thirds of all liver related deaths occur in men & 1 out of 3 liver-related deaths occur among females Within this estimate, liver cancer accounts for 600,000 to 900,000 deaths.
1 Currently liver disease is the eleventh-leading cause of death, but liver deaths may be underestimated.
2 Liver disease is fast spreading like an epidemic in India with one out of every five adults getting affected. Liver related deaths in India have reached a staggering figure of 268,580 (3.17% of all deaths) per year contributing to 18.3% of global liver-related deaths that account over 2 million deaths globally per year. 
3 There are more than a hundred different liver diseases of diverse nature that are being identified as the leading causes of disability, disease, and death globally. ï‚— Liver diseases are broadly caused by hepatitis viruses (A to E), alcohol, non-alcoholic fatty liver disease (NAFLD), drugs, autoimmune and genetic diseases, cryptogenic and liver tumors-benign and malignant. ï‚— Liver deaths occur predominantly because of liver cirrhosis, acute liver failure, and liver cancer In Ayurveda, much attention has been given to Anga-Avayava Utpatti in Garbha Avakranti Sharira4. Garbha Avakranti refers to the growth of the Garbha in Garbhavastha. The discipline of medicine known as embryology studies the formation of the human embryo and its development inside the uterus until the delivery of a child. Different opinion exists regarding Anga-Avayava Utpatti by various Acharya. Acharya Sushruta, while describing the formation of organs in the foetus, has mentioned that the Yakrita (liver), Pleeha (spleen) are developed from Shonita.5 In Kashyap Samhita, it has been mentioned that during Anga- Avayava Utpatti (development of different organs in fetus) Hardiya is formed from Shonita, Yakrita from Hardiya, Pleeha is formed from Yakrita, and from Pleeha Fuffus is formed. As per Samhitas, Shonita is involved in development of different Anga- Avayava. We has observed that in particular diseases like Pandu (anaemia), Pleeharoga (splenomegaly), Twak Vikara (skin disorder), Kamala (jaundice), etc, Yakrita and Pleeha are affected where Shonita is the common factor. Some studies have been done & it has been observed that Shonita is a common factor in the diagnosis and treatment of diseases. Some drugs like Lauha Bhasma, Tamra Bhasma, Manjistha, Shatavari, and Punarnava, which are used for Shonita, can be beneficial for the diseases of Yakrita, and Pleeha.6 During the treatment of the Yakrita dushti (liver disorders), we mainly focus on those drugs which are mentioned under the heading of Yakrita Rogadhikar. We always ignore the concept of embryogenesis i.e. Shonita is responsible for the formation of Yakrita. This study mainly focuses on that concept & seeks to know the effect of Rakta Prashadhak Aushodha on Yakrita dushti.

NEED TO STUDY 
 1. There is a need to explore the fundamental principles related to Anga-Avyava Utpatti under the lens of clinical utility. 
 2. The Samhita principles of embryogenesis need to be re-validated and established. 
 3. The prevalence of morbidity & mortality of liver diseases is currently very high and there is a lack of effective treatment for curing the disorder so there is a need to discover new drugs & concept of treatment.
 4. There is a need to focus on the concept of Rakta Prashadhan in liver disorders as we mainly follow the treatment concept of Yakrita dushti, that focus on drugs those are mentioned under Yakrita Rogadhikar.
 
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