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CTRI Number  CTRI/2021/01/030302 [Registered on: 07/01/2021] Trial Registered Prospectively
Last Modified On: 04/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study of Curcuvail® in in patients with Non-alcoholic Fatty Liver Disease  
Scientific Title of Study   A prospective, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of Curcuvail® of K Patel Phyto Extractions Pvt. Ltd. in patients with Non-alcoholic Fatty Liver Disease (NAFLD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CSI2003, Version 2.0 dated 26-Nov-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Nimesh Parikh 
Designation  Chief Operating Officer 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall Road, Science City Road, Sola, Ahmedabad, India

Ahmadabad
GUJARAT
380060
India 
Phone  9904468245  
Fax    
Email  nimesh.p@cod-research.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Nimesh Parikh 
Designation  Chief Operating Officer 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall Road, Science City Road, Sola, Ahmedabad, India


GUJARAT
380060
India 
Phone  9904468245  
Fax    
Email  nimesh.p@cod-research.com  
 
Details of Contact Person
Public Query  
Name  Mr Nimesh Parikh 
Designation  Chief Operating Officer 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall Road, Science City Road, Sola, Ahmedabad, India


GUJARAT
380060
India 
Phone  9904468245  
Fax    
Email  nimesh.p@cod-research.com  
 
Source of Monetary or Material Support  
K Patel Phyto Extractions Pvt. Ltd. 
 
Primary Sponsor  
Name  K Patel Phyto Extractions Pvt Ltd 
Address  K Patel Phyto Extractions Pvt. Ltd. 507 Eureka Tower, Mindspace, Off Link Road, Malad West, Mumbai - 400064 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Gaurav Chhaya  Sanjivani Super Speciality Hospital  1, Uday Park Society, Near Sunrise Park, Vastrapur, Ahmedabad-380015 Gujarat, India
Ahmadabad
GUJARAT 		 9825324056

gaurav.chhaya2010@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjivani Hospital Ethics Committee  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: Non-alcoholic Fatty Liver Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuvail® 250 mg capsule  Content: Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice daily Route of administration:Oral Duration of therapy: 60 Days 
Comparator Agent  Placebo  Content: Placebo product Dose: One capsule Frequency: Twice daily Route of administration: Oral Duration of therapy: 60 Days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide written informed consent prior to any study-related activities being performed.
2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
3. Male and Female patients aged between 18 years to 70, both inclusive.
4. Patients diagnosed with fatty liver (grades 1-3) based on liver ultrasonography.
5. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
6. Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation). 
 
ExclusionCriteria 
Details  1. Hypersensitivity to Curcuvail or related class of drugs or to any of the excipients of the formulation. 2. Fatty liver secondary to alcohol consumption. 3. History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink - 5 ounce [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within the previous 6 months from screening 4. Addicted Alcoholics and- or drug abusers. 5. History or presence of coronary, renal, pulmonary and thyroid disease. 6. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microleter. 7. Patients using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization. 8. Difficulty in swallowing and retaining oral formulation. 9. Known HBs Ag positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha- 1 antitrypsin deficient patients 10. Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD 11. Patient has condition or is in a situation which, in the investigator’s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patient’s participation in the study 12. Participation in any other clinical study within 30 days before the first dose of Investigational Product. 13. Pregnant or Lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients showing improvement in fatty liver grading based on liver USG  to Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Change in fatty liver grading based on liver USG  from baseline to day 60 
AST to Platelet Ratio Index (APRI)  to day 60 
Change in Fibroscan  to day 60 
Change in lipid profile and liver enzymes ALT and AST  from baseline to day 60 
 
Target Sample Size
Modification(s)  		 Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/01/2021 
Date of Study Completion (India) 24/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="24" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC). 
Currently there are no effective medications to cure NAFLD. Current treatments for NAFLD include weight reduction through lifestyle modification and exercise, insulin-sensitizing agents, lipid-lowering agents, and hepatoprotective drugs. However, the efficacy of these therapies is not satisfactory, some drugs may even induce liver toxicity. Thus, it is necessary to develop novel therapies that are effective and safe for the treatment of NAFLD.
Hence, K Patel Phyto Extractions Pvt. Ltd. has formulated Curcuvail®. Objective of the current study is to compare efficacy, safety and tolerability of test formulation Curcuvail® by administering the medications in the adult patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD) and eligible to receive Curcuvail® as treatment.
 
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