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Clinical Trials/CTRI/2018/05/014139
CTRI/2018/05/014139CompletedPhase 1

“Pre & Post Clinical Test to Assess the Antihyperlipidimic Effect of Averrhoa bilimbi Fruitâ€

DrSarathS1 site in 1 country30 target enrollmentStarted: October 15, 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Reduction in LDL,HDL,VLDL,TG,TC

Study Overview

Brief Summary

Background: Lipid is the scientific term for fats in the blood. Atproper levels, lipids perform vital operations in our body, but it can alsocause health problems if they are present in more amounts. The termHyperlipidemia (high lipid level) includes several conditions, but it usuallymeans high cholesterol and high triglyceride levels, however when its level isincreased becomes severe medical intervention ismandatory though allopathy offers varieties of internal medicine where there isa risk of being affected with side effects on kidney and liver. Though itappears like a minor health issue, it is very embarassing when severe since itwill affect the cardiovascular system. This study offers an effectivemanagement of hyperlipidemia, as I would be briefing in my case study. Averrhoa bilimbi fruit is a medicine used by traditional Practitioners tolower 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 andphytochemical profile of the test drug Bilimbi(Averrhoa bilimbi Linn).

Method(s)/ Procedures: Themethodology of the study is divided into 3 sections: Pharmacognosticalanalysis, Preliminary Phytochemial analysis & Clinical Study. In the Pharmacognosticalanalysis, the genuineness of test drug, fruit of Bilimbi (Averrhoa bilimbiLinn), were done by macroscopic parameters, Histological parameters &Powder Microscopy. In Preliminaryphytochemial analysis, the physico-chemical parameters, extractivevalues, qualitative analysis of extractives and TLC of the powder of fruit of Bilimbi (Averrhoa bilimbi Linn) were done. The Clinical Study is to evaluatethe efficacy of Bilimbi in themanagement of Hyperlipidemia. 30Patients were selected according to the inclusion and exclusion criteria fromOut Patient Department of Amrita school of Ayurveda Hospital. The test drug, Bilimbi (water extract, 500 mg), weregiven to the patients for a period of 21 days on morning hours before food.Assessment was done onchecking lipid profile. Follow up was done after three weeks. Assessment was done, before treatment, after completionof the treatment (after 21 days) & during follow upperiod (after three weeks). Thefindings were recorded in the specific case proforma and the efficacy wasstatistically analysed. Preand 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 studywas devoid of impurities and the values assure the quality of the drug.Statistical Analysis was done using SPSSVER. 20. Data of 30 patients wastaken for Statistical Analysis. Pairedt test is done for blood lipidlevel, to interpret the time of significant change. Overall assessmentin reduction of was found to be significant with p ˂0.01.In the study 63.3% ofcases were found to be females even though no sex determination wasdiscriminated.

Conclusion: Microscopicstudy of Bilimbi (Averrhoa bilimbiLinn.) revealed that the sample taken for the study was genuine. Thepreliminary phytochemical screening of fruit powder of Bilimbi (Averrhoa bilimbi Linn.) with the various chemicaltests (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 effectivein lowering the lipid levels.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
25.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Serum cholesterol >240mg/dl <340mg/dl.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Reduction in LDL,HDL,VLDL,TG,TC

Time Frame: Assessment on 1st day , 21st day and 42nd day.

Secondary Outcomes

  • breathing difficulty , burning sensation were reduced.(Assessment on 1st day, 21st day, and 42nd day.)

Investigators

Sponsor
DrSarathS
Sponsor Class
Other [self]

Study Sites (1)

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