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CTRI Number  CTRI/2019/01/017201 [Registered on: 22/01/2019] Trial Registered Prospectively
Last Modified On: 10/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to find the effect of Amla extract in obese people 
Scientific Title of Study   A Randomized, Open Label Clinical Study To Evaluate The Efficacy And Safety Of Amla Extract In Obese Subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-07ASE0918H3-SYN06, V-01, Dt: 23 Oct 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla 
Designation  Deputy General Manager, Research and Development 
Affiliation  Arjuna Natural Ltd  
Address  Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla 
Designation  Deputy General Manager, Research and Development 
Affiliation  Arjuna Natural Ltd  
Address  Division of Research and Development, Department of Clinical Trial, No. 7/8, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Dr Binu T Kuruvilla 
Designation  Deputy General Manager, Research and Development 
Affiliation  Arjuna Natural Ltd  
Address  Division of Research and Development, Department of Clinical trial, No. 7/8, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax  04842622612  
Email  drbinu@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Limited, Aluva, Kerala 
 
Primary Sponsor  
Name  Arjuna Natural Ltd 
Address  Bank Road, Aluva - 683 101 
Type of Sponsor  Other [Neutraceutical Industry] 
 
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 Giriraj KV  Rajalakshmi Hospital  Room No. 1, General Medicine OPD, Ground Floor, No.21/1,Lakshmipura Main Road, Opposite Lakshmipura Lake, Vidyaranyapura Post, Bangalore
Bangalore
KARNATAKA 		 08023254855

drgirirajkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee (RHIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amla extract (AMX 160)  500 mg capsule of Amla extract (AMX 160) one in the morning and one at night after food for 90 days  
Intervention  Amla extract (AMX 160)  500 mg capsule of Amla extract (AMX-160) once daily at night after food for 90 days 
Intervention  Amla extract (AMX 500)  250 mg capsule of Amla extract(AMX-500) one in the morning and one at night after food for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with BMI ≥ 35 kg/m2
2. Male subjects with waist circumference > 102 cm and female subjects with waist circumference > 88 cm.
3. Subjects with Triglycerides TG ≥ 200 mg/dL
4. Subjects with Total Cholestrol ≥ 200 mg/dL
5. Subjects who have provided signed informed consent for the trial.
 
 
ExclusionCriteria 
Details  1. 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 or use of antihypertensive medications, dose of which is not stable in the last one month) 

2. Subjects with unstable diabetes, using insulin, glitazones, other hypoglycemic dose of which is not stable in last one month 

3. Subjects with Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
4. Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 

5. Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine≥ 2.0 mg/dl) 

6. Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures 

7. Subjects with known history of hypersensitivity to amla or any product containing amla extract.
8. Subjects with history of alcohol intake daily or drug abuse.
9. Subjects with any other serious concurrent illness or malignancy. 

10. Participation in another clinical trial in the past 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean percent change in BMI, Waist circumference, Total body fat percentage, Visceral fat percentage at the end of 90 days.  Day 0, Day 45, Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mean percent change in TG, TC, FBS at the end of 90 days.
2. Mean percent change in Weight, Hip Circumference, Waist: Hip ratio at the end of 90 days.
3. Mean percent change in Segmental subcutaneous fat percentage, Segmental skeletal muscle percentage at the end of 90 days.
4. Mean change in Resting Metabolism at the end of 90 days.
 		 Day 0, Day 45, Day 90. 
Other outcome:
Mean change in Body Age and GPAQ –Improvement in the mean MET score at the end of 90 days.
 		 Day 0, Day 45, Day 90 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="58" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/01/2019 
Date of Study Completion (India) 18/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Obesity is one among the major health problem which is increasing day by day across the world. Obesity is defined by body mass index (BMI) and further evaluated in terms of total amount of fat and distribution of fat in the body via the waist-hip ratio. The objective of this randomized, open label, single centered clinical study is to evaluate the safety and efficacy of Amla Extracts of M/s Arjuna Natural Limited, Kerala. Sixty obese subjects with dyslipidemia will be enrolled in the study and divided into three groups. First group will be given Amla extract (AMX 160) 500 mg once daily, second  group will be given Amla extract (AMX 160) 500 mg twice daily and the third group will be given Amla extract (AMX 500) 250 mg twice daily for 90 days. The effect of amla extracts on lipid levels, body composition and  waist – hip ratio are assessed on Day 0, Day 45 and Day 90.

 
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