FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056463 [Registered on: 14/08/2023] Trial Registered Prospectively
Last Modified On: 09/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study To Evaluate The Effect Of Yavaksharadi Yoga In Non-Alcoholic Fatty Liver Disease 
Scientific Title of Study   Clinical Study To Evaluate The Effect Of Yavaksharadi Yoga 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  N MADHURI DEVI  
Designation  Professor and HOD, Department of Shalyatantra 
Affiliation  Pankajakasthuri Ayurveda Medical College And PG Center  
Address  Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695572
India 
Phone  9447743331  
Fax    
Email  drmadhurisreyas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  N MADHURI DEVI  
Designation  Professor and HOD, Department of Shalyatantra 
Affiliation  Pankajakasthuri Ayurveda Medical College And PG Center 
Address  Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695572
India 
Phone  9447743331  
Fax    
Email  drmadhurisreyas@gmail.com  
 
Details of Contact Person
Public Query  
Name  N MADHURI DEVI  
Designation  Professor and HOD, Department of Shalyatantra 
Affiliation  Pankajakasthuri Ayurveda Medical College And PG Center  
Address  Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Pankajakasthuri Ayurveda Medical College And PG Center ,Killy, Kattakkada, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695572
India 
Phone  9447743331  
Fax    
Email  drmadhurisreyas@gmail.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Ayurveda Medical College And PG Center,Killy, Kattakkada, Thiruvananthapuram, Kerala -695572 
 
Primary Sponsor  
Name  PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE AND PG CENTRE  
Address  Pankajakasthuri Ayurveda Medical College And PG Center,Killy, Kattakkada, Thiruvananthapuram, Kerala -695572 
Type of Sponsor  Other [NIL] 
 
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 
ABHISHEK K V  Pankajakasthuri Ayurveda Medical College and PG Centre  OP and IP Department of Shalyatantra, room number-H04 Kattakkada,Thiruvananthapuram, kerala-695572 pin-695572
Thiruvananthapuram
KERALA 		 7012463520

abhishek.nyyt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(IEC) Pankajakasthuri Ayurveda Medical College & PG Centre  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: YAVAKSHARADI YOGA, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -KASHAYA), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects with Grade I & II Non- alcoholic fatty liver disease.
2. Age group-20-60 years.
3. Subjects will be selected irrespective of gender, caste, religion.
4. Subjects willing to sign informed consent 
 
ExclusionCriteria 
Details  1. Non-Alcoholic fatty liver disease Grade III
2. Ascites
3. Subjects with following drug intake – antiepileptic drugs, antituberculosis
drugs, steroids, and heparin
4. Liver cirrhosis.
5. Kshara contraindicated patients
6. Known cases of Hepatitis B, Hepatitis C, Carcinoma of liver, Renal failure,
Cardiac diseases and other systemic diseases.
7. Women who are Pregnant, planning to become pregnant during the study period, breastfeeding mothers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

• Objective criteria –
LFT
-USG Abdomen to assess the following
: Liver size
: Grading of NAFLD 		 Assessment of Objective criteria USG & LFT will be done before treatment &
on 46th day after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
• Subjective criteria
1) Appetite
2) Anorexia
3) Fatigue
4) Dull or aching pain in the right upper quadrant of abdomen
5) Pedal oedema 		 Assessment of subjective criteria like Appetite, Anorexia, Fatigue,
Aching pain on right upper quadrant & pedal oedema will be done before treatment,31st and 46th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/08/2023 
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="3"
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   Non-alcoholic fatty liver disease (NAFLD) is a broad term which describe the build-up of excessive fat in the liver cell, in the absence of alcohol intake (<20gm/day for women and <30 gm/day for men). In the majority of patients, NAFLD is commonly associated with metabolic co-morbidities such as obesity, diabetes mellitus and dyslipidaemia. Yavaksharadi yoga which contains Yava kshara, Pippali, Vidalavana and Putika (Chiruvilwa) kashaya is one among the formulations mentioned in Yogaratnakara for Yakrit rogas. The drugs used might helpful in normalising the metabolic functions of liver. The present study is proposed to evaluate the effect of Yavaksharadi yoga in Non-alcoholic fatty liver disease. Study design will be clinical trial, done among 30 participants for a period of 45 days in the age group of 20-60 years. Participants diagnosed as per diagnostic criteria and satisfying the inclusion criteria will be selected conveniently from OPD and IPD of Pankajakasthuri Ayurveda Medical College and PG Centre. Subjects will be given the prepared medicine 500 mg morning 1 hour before food with Putika (Chiruvilwa) kashaya as Anupana for a period of 30 days. Assessment of Objective criteria i.e., USG and LFT will be done before treatment and on 46th day, Assessment of subjective criteria like Appetite, Anorexia, Fatigue, Aching pain on right upper quadrant and Pedal oedema will be done before treatment,31st and 46th day. No special diet modification or lifestyle change is advised during this period. The data will be analysed using the appropriate statistical tests.
Null hypothesis: Yavaksharadi yoga has no significant effect in Non-alcoholic fatty liver disease. Alternate hypothesis: Yavaksharadi yoga has a significant effect in Non-alcoholic fatty liver disease
 
Close