| CTRI Number |
CTRI/2015/04/005682 [Registered on: 08/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Randomized, Double Blind, Placebo Controlled, Multicentre Clinical Trial to Assess the Efficacy and Safety of Amla Extract (AMX160) in Patients with Dyslipidaemia |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Multicentre Clinical Trial to Assess the Efficacy and Safety of Amla Extract (AMX160) in Patients with Dyslipidaemia |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Haridas Upadya |
| Address |
Aadhitya Adhikari Hospital
Contour Road, Gokulam, Mysore
Mysore
KARNATAKA
570002
India |
| Phone |
9880046375 |
| Fax |
|
| Email |
dr.upadya123@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Binu T Kuruvilla |
| Address |
Arjuna Natural Extracts Limited, Bank Road, Aluva, Kochi, Kerala
Kozhikode
KERALA
683101
India |
| Phone |
04842532404 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepa Subramanian |
| Address |
Syncretic Clinical Research Services Pvt. Ltd.
No.32, Door No. 4 (Old No.38), 5th cross, 11th Main, Vasanthnagar, Bangalore
Bangalore
KARNATAKA
560052
India |
| Phone |
9972598010 |
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Extracts Ltd. |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Extracts Ltd |
| Address |
Arjuna Natural Extracts Ltd
P.B. No 126, Bank Road,
Alwaye, Kerala,
I N D I A -683 101. |
| Type of Sponsor |
Other [Manufacturer, Limited Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haridas Upadya |
Aadhitya Adhikari Hospital |
Aadhitya Adhikari Hospital, Contour Road, Gokulam, Mysore: 570002
Mysore
|
9880046375
dr.upadya123@gmail.com |
| Dr Prabhu S |
Life Care Hospital |
No.99, OM Complex, 20th Main, Gangothri Circle, BTM 1st Stage, Bangalore - 560029
Bangalore
|
9886937119
svpm333@yahoo.com |
| Dr Poorna Prasad S |
Prashanth Hospital |
#90/d, Bommanahalli Circle, Hosur Main Road, Bangalore: 560068
Bangalore
|
9741941064
drpoorna.prasad@gmail.com |
| Dr Aravinda Prasad |
Sri Venkateshwara Hospital |
#86, Hosur Main Road, Madiwala, Bangalore: 560068
Bangalore
|
9164242782
draravindaprasad.sv@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Life Care Hospital Institutional Ethics Commitee |
Approved |
| Mysore Clinical Research Ethics Committee |
Approved |
| Prashanth Hospital Ethics Commitee |
Approved |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
| SS Institute of Medical Research Center Institutional Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects whose Triglycerides and Total cholesterol are more than 200 mg/dL and Low Density Lipoproteins more than 130 mg/dL. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amla Extract (AMX160) |
Amla Extract (AMX160) 500 mg capsule of M/s Arjuna Extract Limited, Kerala |
| Comparator Agent |
Placebo |
Placebo capsule of M/s Arjuna Extract Limited, Kerala |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 30-65 years
2. Patients with dyslipidaemia having Triglycerides (TG) >200 mg/dL,
LDL cholesterol > 130 mg/dL,
Total cholesterol > 200 mg/dL
and
HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women
3. Patients not taking any medication (including herbal product) for management of dyslipidaemia since last 4 weeks
4. Informed consent of the patient |
|
| ExclusionCriteria |
| Details |
1. Patients with more than 2 of the following risk factors -
1.1. Cigarette smoking
1.2. Hypertension (BP > 140/90 mmHg or on antihypertensive medication)
1.3. Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years)
1.4. Age (men > 45 years; women > 55 years)
2. Patients 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. Patients with very high triglyceride levels i.e. > 500 mg/dL
4. Patients with FBS more than 150 mg/dL, using insulin, glitazones. Patients using other hypoglycaemics, dose of which is not stable in last one month
5. Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
6. Patients with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine greater than or equal to 2.0 mg/dl)
7. Patients with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures
8. Patients with known history of hypersensitivity to amla or any product containing amla extract
9. Patients with continuing history of alcohol and / or drug abuse.
10. Patients with any other serious concurrent illness or malignancy.
11. Participation in another clinical trial in the past 3 months |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Mean percent change in TG levels at the end of 12 weeks in the two groups |
Day 0 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean percent change in Total cholesterol, LDL and VLDL levels
2. Mean change in the Atherogenic Index of Plasma
3. Mean change in apolipoprotein B (apoB), apolipoprotein A1 (apoA1) and their ratio
4. Mean change in FPG and HbA1c levels
5. Mean change in hs-CRP, homocysteine, Coenzyme Q10 levels
6. Proportion of patients achieving ATP goals (Triglyceride 150 mg/dL, LDL 100 mg/dL, HDL 40)
7. Change in the HMG-CoA reductase activity |
Day 0 and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
30/03/2015 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Upadya H, Prabhu S, Prasad A, Subramanian D, Gupta S, Goel A. A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia. BMC complementary and alternative medicine. 2019;19(1):27. PubMed PMID: 30670010
|
Brief Summary
Modification(s)
|
Randomized, double blind, placebo controlled studies are considered to be of the highest standards for the assessment of efficacy and safety of a study medication; accordingly the same design is used for this study. Patients with dyslipidaemia will be enrolled in the study to assess the effect of Amla Extract (AMX160) on lipid levels. Patients with severe disease or having 2 or more risk factors as per the ATP III guidelines will not be enrolled in the study as this is a placebo controlled trial and half of the patients in the study will not be receiving any active treatment.18 As most of the lipid lowering agents provide a peak action by 4 weeks and also various international clinical studies evaluating the efficacy and safety of medications for dyslipidaemia have a 12 week study period, a follow up of 12 weeks is planned in the study. Moreover, long term study cannot be justified with a placebo arm. All the patients enrolled in the study will also be asked to initiate lifestyle changes (healthy diet with aerobic exercise at least 4 days a week) along with the study medication.
The objective of this clinical study is to evaluate the efficacy and safety of Amla Extract (AMX160) of M/s Arjuna Natural Extracts Limited, Kerala as compared to the matching placebo in patients with dyslipidaemia aged 30-65 years.
Type of study: A prospective, randomized, double blind, parallel, placebo controlled, multicentre, clinical study.
Study groups Test group: Amla Extract (AMX160) 500 mg capsule of M/s Arjuna Natural Extracts Limited, Kerala Reference group: Matching Placebo |
