| 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 |
|
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Primary Sponsor
|
| Name |
DrSarathS |
| Address |
Sreenivas
IInd milestone
KollM |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSreekumar |
Sreenivas
kilikollour
kollam |
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Serum cholesterol level more than 240mg/dl and less than 340mg/dl, |
|
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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. |
|
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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 |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in LDL,HDL,VLDL,TG,TC |
Assessment on 1st day , 21st day and 42nd day. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| breathing difficulty , burning sensation were reduced. |
Assessment on 1st day, 21st day, and 42nd day. |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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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