HypercholesterolemiaNCT03479983
Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
A study testing AMX160 in people with Hypercholesterolemia, run by Arjuna Natural Limited at 1 site in Armenia.
Trial summary
This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- AMX160
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteArmenia
- Study dates
- 4 Jun 2018to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males and females aged 18 to 65 years with hypercholesterolemia symptoms: blood Triglycerides, >200 mg/dL, blood cholesterol >200 mg/dL, blood LDL cholesterol >130 mg/dL
- Other requirements for inclusion in the study are:
- 2. Moderate-intensity physical activity (less than 150 minutes or less than 75 minutes of vigorous-intensity physical activity throughout the week) 3. No medication taken for management of hypercholesterolemia during last 4 weeks.
- 4. Ability to understand and provide signed informed consent. 5. Ability to participate in the study.
Who cannot join
- 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)
- Very high triglyceride levels i.e. > 500 mg/dL
- Diabetes (Fasting Blood Sugar>150 mg/dL), using insulin, glitazones , another hypoglycemic dose of which is not stable in last one month
- Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- Hepatic impairment (Alanine transaminase or Aspartate transaminase levels > 3.0 mg/dl Upper Limit of Normal (ULN)) or renal impairment (serum creatinine≥ 2.0 mg/dl)
- Severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures
Show all 16Show fewer
- Known history of hypersensitivity to Indian Gooseberry or any product containing Indian Gooseberry extract
- Patients with history of alcohol intake (For females >3 drinks / day or >7 drinks / week. For Males >4 drinks/ day or > 14 drinks / week).
- Patients taking any narcotics and prohibited substances.
- Serious concurrent illness or malignancy.
- Agreements of participation in another clinical trial in the past 3 months
- Two of the following risk factors:
- Cigarette smoking (Current / Previous smoker < 1 yr)
- Hypertension (BP >140/90 mmHg or on antihypertensive medication)
- Low HDL cholesterol (<40 mg/dL)
- Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
Trial locations and contacts
1 site in 1 country.
Armenia1 site, 1 recruiting
- Recruiting
Clinic of General and Invasive Cardiology University Hospital 1, YSMU
Yerevan, 375025
Laura Sahakyan, MD
About this study
Official title: A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia.
Read the detailed description
Phyllanthus emblica L. fruit (Emblica officinalis) has potent antioxidant properties. Animal studies indicate that flavanoids from E. officinalis effectively reduced lipid levels in serum and tissues and had a significant inhibitory effect on hepatic hydroxymethylglutaryl-coenzyme A reductase activity.
The primary aim of this study is to determine whether Phyllanthus emblica L. fruit extract AMX160 is an effective treatment for hypercholesterolemia patients as compared to placebo. The investigators hypothesize that Phyllanthus emblica L. fruit extract AMX160 will significantly lower the total cholesterol as compared to placebo in patients with Hypercholesterolemia. A total of 132 patients including males and females with hypercholesterolemia will be assigned at random to one of the two investigational products. The study is expected to have a treatment duration of 90 ± 10 days and a total duration of 118 days including 14 days of grace period and 14 days of screening period per patient.
- Conditions
- Hypercholesterolemia
- Being tested
- AMX160, Placebo
- Keywords
- Indian gooseberry, Total cholesterol, Triglycerides
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMX160Dietary supplement
Also called Phyllanthus emblica L., Indian Gooseberry, Emblica officinalis
500 mg Phyllanthus emblica L. fresh fruit extract capsules
PlaceboDietary supplement
500 mg roasted rice powder in visually identical capsules
| Study group | Role | What they receive |
|---|---|---|
| AMX160 | Experimental | 500 mg (one capsule) x 2 times daily for 90 days Receives: Dietary Supplement: AMX160 |
| Placebo | Placebo comparator | 500mg (one capsule) x 2 times daily for 90 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Secondary outcomes (12)
Change in Triglycerides
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Change in Low Density Lipoprotein Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Change in High Density Lipoprotein Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Change in Very Low Density Lipoprotein Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Change in Triglyceride /High Density Lipoprotein Cholesterol ratio
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline, Day 45 & Day 90
Change in Apolipoprotein A-1
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in Apolipoprotein B
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in Apolipoprotein B/Apolipoprotein A-1 Ratio
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in hydroxymethylglutaryl-coenzyme A
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in Coenzyme Q10
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in Atherogenic index of Plasma
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40)
The change over time from the baseline to end of treatment, both within and between the group.
Measured: Baseline & Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start4 Jun 2018
- Primary completionMay 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjuna Natural Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hamayak Sisakian, MD, Principal investigator, Yerevan State Medical University, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479983
- Sponsor's protocol ID
- AN-06ASE 0717H4-YSM01
- Status last verified
- Jan 2019
- First submitted
- 21 Mar 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing can be carried out through a proper research proposal to the scientific review board of Arjuna Natural Ltd except in cases where Arjuna Natural Ltd. has no legal authority because the product has been out-licensed to another company or there is no feasible means to anonymise the data and redact personally identifiable information without compromising the privacy and confidentiality of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03479983
- Acronym / sponsor ID
- AN-06ASE 0717H4-YSM01
- Conditions
- Hypercholesterolemia
- Keywords
- Indian gooseberry, Total cholesterol, Triglycerides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Arjuna Natural LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia.
Detailed description
Phyllanthus emblica L. fruit (Emblica officinalis) has potent antioxidant properties. Animal studies indicate that flavanoids from E. officinalis effectively reduced lipid levels in serum and tissues and had a significant inhibitory effect on hepatic hydroxymethylglutaryl-coenzyme A reductase activity.
The primary aim of this study is to determine whether Phyllanthus emblica L. fruit extract AMX160 is an effective treatment for hypercholesterolemia patients as compared to placebo. The investigators hypothesize that Phyllanthus emblica L. fruit extract AMX160 will significantly lower the total cholesterol as compared to placebo in patients with Hypercholesterolemia. A total of 132 patients including males and females with hypercholesterolemia will be assigned at random to one of the two investigational products. The study is expected to have a treatment duration of 90 ± 10 days and a total duration of 118 days including 14 days of grace period and 14 days of screening period per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| AMX160 | Experimental | Dietary Supplement: AMX160500 mg (one capsule) x 2 times daily for 90 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo500mg (one capsule) x 2 times daily for 90 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Males and females aged 18 to 65 years with hypercholesterolemia symptoms: blood Triglycerides, >200 mg/dL, blood cholesterol >200 mg/dL, blood LDL cholesterol >130 mg/dL
- 2. Moderate-intensity physical activity (less than 150 minutes or less than 75 minutes of vigorous-intensity physical activity throughout the week) 3. No medication taken for management of hypercholesterolemia during last 4 weeks.
- 4. Ability to understand and provide signed informed consent. 5. Ability to participate in the study.
Key exclusion criteria (16 listed)
- 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)
- Very high triglyceride levels i.e. > 500 mg/dL
- Diabetes (Fasting Blood Sugar>150 mg/dL), using insulin, glitazones , another hypoglycemic dose of which is not stable in last one month
- Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- Hepatic impairment (Alanine transaminase or Aspartate transaminase levels > 3.0 mg/dl Upper Limit of Normal (ULN)) or renal impairment (serum creatinine≥ 2.0 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMX160Also: Phyllanthus emblica L., Indian Gooseberry, Emblica officinalis500 mg Phyllanthus emblica L. fresh fruit extract capsules | Dietary supplement | AMX160 |
| Placebo500 mg roasted rice powder in visually identical capsules | Dietary supplement | Placebo |
Primary outcome
Change in Total Cholesterol
Time frame: Baseline, Day 45 & Day 90
The change over time from the baseline to end of treatment, both within and between the group.
12 secondary outcomes
Change in Triglycerides
Time frame: Baseline, Day 45 & Day 90
Change in Low Density Lipoprotein Cholesterol
Time frame: Baseline, Day 45 & Day 90
Change in High Density Lipoprotein Cholesterol
Time frame: Baseline, Day 45 & Day 90
Change in Very Low Density Lipoprotein Cholesterol
Time frame: Baseline, Day 45 & Day 90
Change in Triglyceride /High Density Lipoprotein Cholesterol ratio
Time frame: Baseline, Day 45 & Day 90
Change in Apolipoprotein A-1
Time frame: Baseline & Day 90
Change in Apolipoprotein B
Time frame: Baseline & Day 90
Change in Apolipoprotein B/Apolipoprotein A-1 Ratio
Time frame: Baseline & Day 90
Change in hydroxymethylglutaryl-coenzyme A
Time frame: Baseline & Day 90
Change in Coenzyme Q10
Time frame: Baseline & Day 90
Change in Atherogenic index of Plasma
Time frame: Baseline & Day 90
Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40)
Time frame: Baseline & Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: Undecided. Data sharing can be carried out through a proper research proposal to the scientific review board of Arjuna Natural Ltd except in cases where Arjuna Natural Ltd. has no legal authority because the product has been out-licensed to another company or there is no feasible means to anonymise the data and redact personally identifiable information without compromising the privacy and confidentiality of research participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamayak Sisakian, MD principal investigator
Yerevan State Medical University, Armenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMX160 in people with Hypercholesterolemia, run by Arjuna Natural Limited at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binu T Kuruvilla, Dr. (91-9447818432, drbinu@arjunanatural.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Cholesterol (time frame: Baseline, Day 45 & Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.