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CTRI Number  CTRI/2024/08/072611 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of two medicines Vaishwanara Choornam and aqueous extract of Drakshadi Kashayam in patients with Non-Alcoholic Fatty Liver Disease 
Scientific Title of Study   Effectiveness of Vaishwanara Choornam and Drakshadi Kashayam aqueous extract in Non-Alcoholic Fatty Liver Disease 
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 Nidhish Nair 
Designation  PG Scholar, Department Of Kayachikitsa 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram  
Address  Department Of Kayachikitsa, Ground Floor,OPD No.2,Room No 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction,Thiruvananthapuram,Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9995274816  
Fax    
Email  dr.nidhishnair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhish Nair 
Designation  PG Scholar, Department Of Kayachikitsa 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram  
Address  Department Of Kayachikitsa,Ground Floor,OPD No.2,Room No 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9995274816  
Fax    
Email  dr.nidhishnair@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Ambika 
Designation  Professor and H.O.D,Department Of Kayachikitsa 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram  
Address  Department Of Kayachikitsa, Ground Floor,OPD No.2,Room No: 2, Government Ayurveda Medical College and Hospital, Pulimoodu Junction, Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9847457084  
Fax    
Email  ambikachitharanjan@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital,Pulimoodu Junction, Thiruvanathapuram, Kerala,India,Pincode:695001 
 
Primary Sponsor  
Name  NIDHISH NAIR 
Address  Government Ayurveda College and Hospital, Pulimoodu Junction, Thiruvananthapuram, 695001, Kerala, India, Department of Kayachikitsa, OP. 
Type of Sponsor  Other [Self] 
 
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 Nidhish Nair  Government Ayurveda Medical College and Hospital  Department Of Kayachikitsa,Ground Floor,OPD No.2,Room No 2,Pulimoodu Junction,Thiruvananthapuram, Kerala, 695001,India
Thiruvananthapuram
KERALA 
9995274816

dr.nidhishnair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC),Government Ayurveda Medical College and Hospital Thiruvananthapuram,Kerala,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Drakshadi Kashayam, Reference: Ashtangahrudayam,Chikitsasthanam,Jwarachikitsa,Chapter No:1,Shloka No:55, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Vaishwanara Choornam, Reference: Ashtangahrudayam,Chikitsasthanam,Gulmachikitsa,Chapter No14,ShlokaNo:34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Ushnambu), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and Female participants of age group between 25-65 years of age having Grade 1 and Grade 2 Non-Alcoholic Fatty Liver Disease diagnosed through ultrasonography. 
 
ExclusionCriteria 
Details  Known history of any serious systemic illnesses.
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Elevated Liver Enzymes.
Reduction in NAFLD Fibrosis Score. 
60days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 3 
Date of First Enrollment (India)   19/08/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Non-alcoholic fatty liver disease (NAFLD) has a global prevalence of 25% and is a leading cause of cirrhosis and hepatocellular carcinoma. NAFLD encompasses a disease continuum from steatosis with or without mild inflammation (non-alcoholic fatty liver), to non-alcoholic steatohepatitis (NASH), which is characterized by necroinflammation and faster fibrosis progression, NAFLD has a bidirectional association with components of the metabolic syndrome, and type 2 diabetes increases the risk of cirrhosis and related complications

NAFLD may be corelated with Satarpana janya vyadhis due to intake of nidanas there is resultant agnimandyam causing ama formation and vitiation of Kapha and medas leading to accumulation in Yakrith which is Pittasthana  as the disease advances it can result in Dhatupaka (necroinflammation) NASH , the final phase of the disease is characterized by increase of Vata Gunas resulting in fibrosis & cirrhosis.Hence the medicines selected should possess the qualities like deepana,pachana, srothosodhana,vatanulomana and yakruthprasadana.

The study drug Vaishwanara choornam,and Drakshadi Kashyam mentioned in Ashtang Hrudya gulma chikitsa and jwara chikitsa respectively ,the formulation will be prepared  according to the methods adopted from classical Ayurvedic textbooks for choornam and in dose adjusted Kashaya aqueous extract form with date of administration labelled in it for 60 days. An interventional pre – post study in a single group will be conducted in participants attending OPD of Department of Kayachikitsa at Government Ayurveda College, Thiruvananthapuram. Participants will be  advised to take  Vaishwanara Choornam in dose of 6g with Drakshadi Kashyam administered as whole Kashaya aqueous extract at a dose of 3gm (1 sachet) with 96 ml lukewarm water twice daily at 6AM,6PM for a period of 60 days. A total of 120 kashaya aqueous extract sachet and 120 packets of vaishwanara choornam, 30 packets of aqueous extract of kashayam  and 30 packets of choornam  will be  given to the participants in each visit at an interval of 15days.After collecting baseline data participant will be evaluated  on the 0th and 61st day. USG, Scoring and Blood parameters are done before and after the study. The results obtained will be statistically analyzed and concluded.

 

 
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