FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/02/007829 [Registered on: 10/02/2017] Trial Registered Prospectively
Last Modified On: 12/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial of Amla Extract in subjects with abnormal cholesterol levels.  
Scientific Title of Study   A prospective open label clinical study to evaluate the efficacy and safety of Amla extract in the subjects with Abnormal lipid levels 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-05ASE 1216H6-SYN05, Version 01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran Jagalurappa 
Designation  Principal Investigator 
Affiliation  Pristine Hospital 
Address  Pristine Hospital No 877 Modi Hospital Road West of Chord 2nd Stage Ext Bangalore

Bangalore
KARNATAKA
560086
India 
Phone  9972422322  
Fax    
Email  kiran.j79@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla  
Designation  AGM R&D  
Affiliation  Arjuna Natural Extracts Limited  
Address  Arjuna Natural Extracts Limited Research and Development Division Bank Road Always, Kochi

Ernakulam
KERALA
683101
India 
Phone  04842933340  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian  
Designation  Chief Executive Officer  
Affiliation  Syncretic Clinical Research Services Pvt Ltdy 
Address  Syncretic Clinical Research Services Pvt Ltd No32 Door No 4 (Old No.38) 5th cross 11th Main Vasanthnagar

Bangalore
KARNATAKA
560052
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
Arjuna Natural Extracts Ltd, Bank Road, Alwaye, Kerala, I N D I A -683 101 
 
Primary Sponsor  
Name  Arjuna Natural Extracts Ltd  
Address  Arjuna Natural Extracts Ltd, Bank Road, Alwaye, Kerala, I N D I A -683 101. 
Type of Sponsor  Other [[Manufacturer, Limited Company] ] 
 
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 Kiran Jagalurappa  Pristine Hospital and Research Centre  Department of Internal Medicine, No 877, Modi Hospital Road West of Chord Road 2nd Stage Extension
Bangalore
KARNATAKA 		 9972422322

kiran.j79@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Pristine Hospital and Research Centre Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Abnormal Lipid profile 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amla Extract   Amla Extract 500 mg capsule of M/s Arjuna Extract Limited, 500mg capsule twice daily to be taken orally for 3 months 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects aged 18-65 years.
2.Inactive population (defined as less than 150 minutes of moderate-intensity physical activity throughout the week, or less than 75 minutes of vigorous-intensity physical activity throughout the week, or less than an equivalent combination of moderate- and vigorous-intensity activity).
3.Subjects with abnormal lipid levels having Triglycerides >200 mg/dL, LDL cholesterol > 130 mg/dL and Total cholesterol > 200 mg/dL.
4.Subjects not taking any medication (including herbal product) for management of abnormal lipid levels since last 4 weeks .
5.Informed consent of the patient.
 
 
ExclusionCriteria 
Details  1.Subjects with more than 2 of the following risk factors -
Cigarette smoking
Hypertension (BP >140/90 mmHg or on antihypertensive medication)
Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years)
Age (men >45 years; women >55 years).
2.Subjects with uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within the preceding 6 months; unstable angina; congestive heart failure; known or suspected clinically significant valvular heart disease or uncontrolled hypertension (>160/100 mm of Hg or use of antihypertensive medications, dose of which is not stable in the last one month).
3.Subjects with very high triglyceride levels i.e. > 500 mg/dL.
4.Subjects with diabetes (FBS>150 mg/dL),, using insulin, glitazones. Subjects using other hypoglycaemics, dose of which is not stable in last one month.
5.Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilisation).
6.Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine ≥ 2.0 mg/dl).
7.Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures.
8.Subjects with known history of hypersensitivity to amla or any product containing amla extract .
9.Subjects with continuing history of alcohol and / or drug abuse.
10.Subjects with any other serious concurrent illness or malignancy.
11.Participation in another clinical trial in the past 3 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean percent change in TC levels at the end of 90 days.  Day 0 45 and 90 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in apolipoprotein B (apoB), apolipoprotein A1 (apoA1),triglycerides,LDL, VLDL, atherogenic index of plasma (AIP), at the end of 90 days.
Proportion of subjects achieving ATP goals (Triglyceride less than 150 mg/dL, LDL less than 100 mg/dL, HDL more than 40) at the end of the study.
Mean change in CoQ10 levels at the end of 90 days.
Mean change in HMGCoA reductase levels at the end of 90 days.
 		 Day 0 and 90 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 13/03/2017 
Date of Study Completion (India) 22/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

This clinical study is being planned to assess the efficacy and safety of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala for management of abnormal lipid levels in male and female subjects aged 18 to 65. Beside the conventional lipid parameters like TG, TC, LDL, and HDL various other parameters have shown correlation with progression of coronary artery disease. The most important of these parameters include the Atherogenic Index of Plasma (AIP), Apo lipoproteins A1, Apo lipoprotein B and their ratio, Coenzyme Q10 and chronic inflammatory markers like hs-CRP.12-16 This study is being planned to assess the effect of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala on these parameters besides the effect on the conventional lipid parameters.

The objective of this clinical study is to evaluate the efficacy and safety of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala in subjects with abnormal lipid levels aged 18-65 years.

Type of Study: Prospective, open label, single centre study on subjects with abnormal lipid levels to access the safety and efficacy of the study medication. 

 
Close