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							| Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007



	

				
						
 
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																Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007
										

				


				
				
					
					
						
																					
				
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					Vol. 12 No. 7 (2022): July 2022
				
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									Research Articles
							
		



	
		  	 

		
	
		A blend of Sphaeranthus indicus flower head and Terminalia chebula fruit extracts reduces fatty liver and improves liver  function in non-alcoholic, overweight adults
	


	
	
		

							
					Authors

						
							
								Vamsi Krishna Pothula Rajendra
							
															
									Krishna Institute of Medical Sciences Hospital, Nellore, Andhra Pradesh
																	
																																		
	
							
								Sridhar Kurapati
							
															
									Krishna Institute of Medical Sciences Hospital, Nellore, Andhra Pradesh
																	
																																		
	
							
								Sai Krishna Balineni
							
															
									Aditya Multi Speciality Hospital, Guntur, Andhra Pradesh
																	
																																		
	
							
								Naga Tejaswi Tejaswi Gogineni
							
															
									General Medicine Department, Aditya Multi Speciality Hospital,  Guntur, Andhra Pradesh, India
																	
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v12i7.958
						
					
				
			

						
										
					Abstract

					Background: Excessive accumulation of fat in the liver is a common clinical presentation in non-alcoholic fatty liver disease (NAFLD). The increasing prevalence of NAFLD is a growing health problem worldwide. The major risk factors of NAFLD include obesity, hyperlipidemia, and insulin resistance.
Objective: The aim of the present randomized, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of an herbal composition CL16049F1 in reducing fatty liver conditions and improving liver function in non-alcoholic, overweight individuals. CL16049F1 is a patented© blend of Sphaeranthus indicus flower head and Terminalia chebula fruit extracts.
Materials and Methods: Ninety male and female subjects (age: 25-60 yrs., BMI: 23-29 kg/m2) with elevated Fatty Liver Index (FLI) between 31 and 59 were randomized into three groups (n=30). The participants received a daily dose of 300mg CL16049F1, 320 mg Silymarin, or a placebo over a period of 84 consecutive days. FLI was evaluated as the primary efficacy measure. The secondary efficacy measures included the liver enzymes, lipid profile, and oxidative stress markers in serum, A 36-Item Short-Form Health Survey (SF-36), and Gastrointestinal symptoms (GIS) score were also evaluated. The clinical biochemistry, hematology, urine, and vital signs were evaluated as safety measures. Adverse events were also monitored.
Results: Eighty-eight subjects completed the study. Post-trial, the FLI score of CL16049F1-supplemented subjects was reduced by 13.81% (p<0.05) and 16.08% (p<0.05), while the Silymarin supplemented group exhibited reductions of 7.50% (p<0.05) and 7.27% (p<0.05) as compared to baseline and placebo, respectively. CL16049F1 supplementation significantly improved the liver enzymes, lipid profile, and oxidative markers in serum. The changes in the secondary efficacy measures in these treatment groups are comparable. No major adverse events were observed.
Conclusion: CL16049F1 is a well-tolerated and effective herbal formulation to reduce fatty liver and improve liver function in non-alcoholic, overweight subjects.



Keywords: Non-alcoholic fatty liver disease, Fatty liver index, CL16049F1, hepatoprotective botanical formulation.
 

				
			
			

						
																																								
						
		


		

						
										
					
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																			2022-07-18
																	

				
							

			
						
										

											
							
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									Vol. 12 No. 7 (2022): July 2022
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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