Metabolic Syndrome XEarly Phase 1NCT02605655
Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
A Early Phase 1 study testing AMP-1915 in people with Metabolic Syndrome X, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- AMP-1915
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 2015
- Phase
- Early Phase 1
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight (BMI >= 20) or
- Hyperglycemia (FBG>=6.7 mmol/l) or
- Hyperlipidemia (TG >=1.7 mmol/l or TCH>=5.72 mmol/l or HDL-c <=1.00 mmol/l or LDL-c>=3.12 mmol/l)
Who cannot join
- -
About this study
Official title: Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.
Read the detailed description
In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.
This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.
- Conditions
- Metabolic Syndrome X
- Being tested
- AMP-1915, Placebo
- Keywords
- obesity, hyperlipidemia, hyperglycemia
- Medical subject headings
- Metabolic Syndrome, Obesity, Hyperlipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMP-1915Drug
Also called Huangqi San
A traditional Chinese Formula extract from Astragalus, Radix Puerariae and Cortex Mori is mixed into instant noodles. Patients are treated with AMP-1915 as meal.
PlaceboOther
Instant noodles without drug
| Study group | Role | What they receive |
|---|---|---|
| AMP-1915 | Experimental | Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months. Receives: Drug: AMP-1915 |
| Placebo | Placebo comparator | Instant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose (FBG)
Patients' FBG from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment.
The difference between these two time points presents the drug effect.
Measured: Change from baseline FBG at 3 months
Secondary outcomes (4)
Plasma lipid levels
Patients' blood from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment. Triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c) were measured.
The difference between these two time points presents the drug effect, separately.
Measured: Change from baseline lipid levels at 3 months
Plasma Insulin concentration
Patients' insulin concentration from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment.
The difference between these two time points presents the drug effect.
Measured: Change from baseline insulin concentration at 3 months
Body weight
Patients' body weight from both placebo and AMP-1915-treated group was measured before treatment as a baseline and after 3-month treatment.
The difference between these two time points presents the drug effect.
Measured: Change from baseline body weight at 3 months
Plasma HbA1c
Patients' Plasma HbA1c from both placebo and AMP-1915-treated group was measured before treatment as a baseline and after 3-month treatment.
The difference between these two time points presents the drug effect.
Measured: Change from baseline Plasma HbA1c at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guang Ji, MD, Principal investigator, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605655
- Sponsor's protocol ID
- ShanghaiUTCM-01
- Status last verified
- Nov 2014
- First submitted
- 22 Oct 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Clinical Trial of Chinese Formula AMP-1915 on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02605655
- Acronym / sponsor ID
- ShanghaiUTCM-01
- Conditions
- Metabolic Syndrome X
- Keywords
- obesity, hyperlipidemia, hyperglycemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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.
The purpose of this study is to determine whether the Chinese formula AMP-1915 has effect on Metabolic Syndrome (MS) in MS patients. Half of patients received AMP-1915, while the other half received placebo.
Detailed description
In China, the herbal formulas have been used in the treatment of diabetes for centuries. Huangqisan, investigators named it AMP-1915, is one of traditional Chinese herbal formula used to relieve diabetes which was recorded in Shengji Zonglu (General Medical Collection of Royal Benevolence) published in 1117 A.D. AMP-1915 consists of three herbs: Radix Astragali (roots of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, A), Mori Cortex radices (root barks of Morus alba L., M) and Puerariae Lobatae Radix (roots of Pueraria lobata (Willd.) Ohwi., P). Recent studies have shown that these three herbs and their constituents have therapeutic effects on the metabolic disorders.
This randomized, double-blind, placebo-controlled trial was conducted in a community hospital of Shanghai, China. 60 adult participants were metabolic disorder patients according with at least two impaired metabolic profiles (obesity, hyperglycemia, hyperlipidemia or others). During 3-month treatment, participants were randomly divided in to two groups assigned to take AMP-1915 or placebo. AMP-1915 or placebo was mixed into instant noodles as daily meals with same color, shape, size and packaging. BMI, fasting blood glucose (FBG), triglyceride (TG), total cholesterol (TCH), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), insulin, HbA1c were measured before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMP-1915 | Experimental | Drug: AMP-1915Instant noodles contained AMP-1915 2 g/pc with meal, 1 pc/day for 3 months. |
| Placebo | Placebo comparator | Other: PlaceboInstant noodles with the same sharp and color as Experimental noodles with meal, 1 pc/day for 3 months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight (BMI >= 20) or
- Hyperglycemia (FBG>=6.7 mmol/l) or
- Hyperlipidemia (TG >=1.7 mmol/l or TCH>=5.72 mmol/l or HDL-c <=1.00 mmol/l or LDL-c>=3.12 mmol/l)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| AMP-1915Also: Huangqi SanA traditional Chinese Formula extract from Astragalus, Radix Puerariae and Cortex Mori is mixed into instant noodles. Patients are treated with AMP-1915 as meal. | Drug | AMP-1915 |
| PlaceboInstant noodles without drug | Other | Placebo |
Primary outcome
Fasting blood glucose (FBG)
Time frame: Change from baseline FBG at 3 months
Patients' FBG from both placebo and AMP-1915-treated group was collected before treatment as a baseline and after 3-month treatment. The difference between these two time points presents the drug effect.
4 secondary outcomes
Plasma lipid levels
Time frame: Change from baseline lipid levels at 3 months
Plasma Insulin concentration
Time frame: Change from baseline insulin concentration at 3 months
Body weight
Time frame: Change from baseline body weight at 3 months
Plasma HbA1c
Time frame: Change from baseline Plasma HbA1c at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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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.
Guang Ji, MD principal investigator
Shanghai University of TCM
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AMP-1915 in people with Metabolic Syndrome X, run by Shanghai University of Traditional Chinese Medicine.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (FBG) (time frame: Change from baseline FBG at 3 months). 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 7 Jan 2016.