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CTRI Number  CTRI/2018/05/014139 [Registered on: 25/05/2018] Trial Registered Retrospectively
Last Modified On: 20/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Single Arm Study 
Public Title of Study   Effect of Irumban puli in Cholestrol  
Scientific Title of Study   “Pre & Post Clinical Test to Assess the Antihyperlipidimic Effect of Averrhoa bilimbi Fruit” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarath s 
Designation  P.G Scholar 
Affiliation  Amrita Ayurveda college 
Address  Amrita Ayurveda college Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu, Kerala 690546
Sreenivas kilikollour Priyadarshini nagar-129 kollam - 691004
Kollam
KERALA
690546
India 
Phone  8714112010  
Fax    
Email  sarath.cruze@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vimala 
Designation  Professor 
Affiliation  Amrita Ayurveda college 
Address  Amrita Ayurveda college Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu, Kerala 690546
Sreenivas kilikollour Priyadarshini nagar-129 kollam - 691004
Kollam
KERALA
690546
India 
Phone  9497674463  
Fax    
Email  drvimalann@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sarath s 
Designation  P.G Scholar 
Affiliation  Amrita Ayurveda college 
Address  Amrita Ayurveda college Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu, Kerala 690546
Sreenivas kilikollour Priyadarshini nagar-129 kollam - 691004
Kollam
KERALA
690546
India 
Phone  8714112010  
Fax    
Email  sarath.cruze@gmail.com  
 
Source of Monetary or Material Support  
Studies on the Antihyperlipidemic Properties of Averrhoa bilimbi Fruit in Rats Savithri Ambili1,Appian Subramoniam1,Natesan Shanmugam Nagarajan2 Affiliation 1 Department of Phytochemistry and Phytopharmacology, Tropical Botanic Garden and Research Institute,Palode, Thiruvananthapuram, India 
 
Primary Sponsor  
Name  DrSarathS 
Address  Sreenivas IInd milestone KollM 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
DrSreekumar  Sreenivas kilikollour kollam 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SarathS  Amrita Ayurveda Hospital  Department of Dravyaguna vijnanam, Reserch Op no:1, Vavvakavu Vallikavu Road via Pulinilkkumkotta, Vallikavu, Kerala 690546
Kollam
KERALA 
8714112010

sarath.cruze@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Serum cholesterol level more than 240mg/dl and less than 340mg/dl,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BILIMBI CAPSULE   Water extract of Averrhoa bilimbi was used to reduce lipid levels and it was given in capsule of 500mg size before food on morning (single dose in a day) oral administration for a period of 21 days. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Serum cholesterol >240mg/dl <340mg/dl 
 
ExclusionCriteria 
Details  Age below 25yrs and above 70yrs
Patients suffering from known cases of HIV, Tuberculosis, Malignancy, Hypothyroidism, Nephritic syndrome,Autoimmune disease.
Pregnant ladies and lactating mother 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in LDL,HDL,VLDL,TG,TC  Assessment on 1st day , 21st day and 42nd day. 
 
Secondary Outcome  
Outcome  TimePoints 
breathing difficulty , burning sensation were reduced.  Assessment on 1st day, 21st day, and 42nd day. 
 
Target Sample Size   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 1 
Date of First Enrollment (India)   15/10/2016 
Date of Study Completion (India) 18/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


Background: Lipid is the scientific term for fats in the blood. At proper levels, lipids perform vital operations in our body, but it can also cause health problems if they are present in more amounts. The term Hyperlipidemia (high lipid level) includes several conditions, but it usually means high cholesterol and high triglyceride levels, however when its level is increased becomes severe medical intervention is mandatory though allopathy offers varieties of internal medicine where there is a risk of being affected with side effects on kidney and liver. Though it appears like a minor health issue, it is very embarassing when severe since it will affect the cardiovascular system. This study offers an effective management of hyperlipidemia, as I would be briefing in my case study. Averrhoa bilimbi fruit is a medicine used by traditional Practitioners to lower the elevated lipid levels. The fruit of Bilimbi has vitamin C & oxalic acid, so it is consumed with the belief that it can reduce lipids.

Aims: To evaluate the efficacy of Bilimbi (Averrhoa bilimbi Linn) & to study the pharmacognostic and phytochemical profile of the test drug Bilimbi (Averrhoa bilimbi Linn). 

Method(s) / Procedures: The methodology of the study is divided into 3 sections: Pharmacognostical analysis, Preliminary Phytochemial analysis & Clinical Study. In the Pharmacognostical analysis, the genuineness of test drug, fruit of Bilimbi (Averrhoa bilimbi Linn), were done by macroscopic parameters, Histological parameters & Powder Microscopy. In Preliminary phytochemial analysis, the physico-chemical parameters, extractive values, qualitative analysis of extractives and TLC of the powder of fruit of Bilimbi (Averrhoa bilimbi Linn) were done. The Clinical Study is to evaluate the efficacy of Bilimbi in the management of Hyperlipidemia. 30 Patients were selected according to the inclusion and exclusion criteria from Out Patient Department of Amrita school of Ayurveda Hospital. The test drug, Bilimbi (water extract, 500 mg), were given to the patients for a period of 21 days on morning hours before food.Assessment was done on checking lipid profile. Follow up was done after three weeks. Assessment was done, before treatment, after completion of the treatment (after 21 days) & during follow up period (after three weeks). The findings were recorded in the specific case proforma and the efficacy was statistically analysed. Pre and post evaluation of signs & symptoms were done. 

Results: The pharmacognostic & physio-chemical analysis of Bilimbi (Averrhoa bilimbi Linn) showed that, the drug taken for the present study was devoid of impurities and the values assure the quality of the drug. Statistical Analysis was done using SPSS VER. 20. Data of 30 patients was taken for Statistical Analysis. Paired t test is done for blood lipid level, to interpret the time of significant change. Overall assessment in reduction of was found to be significant with p ˂0.01.In the study 63.3% of cases were found to be females even though no sex determination was discriminated.

Conclusion: Microscopic study of Bilimbi (Averrhoa bilimbi Linn.) revealed that the sample taken for the study was genuine. The preliminary phytochemical screening of fruit powder of Bilimbi (Averrhoa bilimbi Linn.) with the various chemical tests (qualitative) revealed the presence of different  chemical constituents like alkaloids, saponins, carbohydrate, phenol and glycosides which revels quality of the study sample. Conclusion was drawn from the clinical Trial and the study drug was effective in lowering the lipid levels.


 
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