CHM for T2DM & MetS

June 5, 2024 updated by: ZhaoXiang Bian, Hong Kong Baptist University

Feasibility, Safety, and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome: A Single-arm Pilot Study

This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 30-75y.
  • Diagnosed with Type 2 diabetes no more than 5 years.
  • Having current prehypertension (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89mmHg), or with a history of hypertension (systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg).
  • Diagnosed with Metabolic Syndrome according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) from Chinese Diabetes Society. People who meet 3 of the following diagnostic criteria or more can be diagnosed as Metabolic Syndrome: (a)Abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) Hyperglycemia: Fasting blood glucose ≥ 6.1mmol/L or 2-hour postprandial glucose ≥ 7.8mmol/L and/or those who have been diagnosed with hyperglycemia and in treatment; (c) Hypertension: blood pressure ≥ 130/85mmHg and/or those who have been diagnosed with hypertension and in treatment; (d) Fasting triglyceride ≥ 1.70mmol/L; (e) Fasting HDL-C < 1.04mmol/L.
  • Diagnosed with Accumulation of phlegm and dampness pattern or Intertwined phlegm and blood stasis pattern based on Traditional Chinese Medicine (TCM) theory.
  • Stable vital signs and with sufficient sensorimotor and language competency for completing assessments.

Exclusion Criteria:

  • Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the CHM.
  • Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
  • Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
  • Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
  • Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
  • Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
  • Experienced at least one day of diarrhea in the past 7 days.
  • With previous stroke history.
  • With unconsciousness, aphasia, and cognitive dysfunction.
  • With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
  • Pregnancy or lactation female.
  • Had joined other clinical trial within past 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chinese Herbal Medicine granules
Drug: Chinese Herbal Medicine granules
The intervention will be a 4 weeks of Chinese Herbal Medicine (CHM) granules, which will consist of six Chinese herbs. Subjects will take one sachet orally, twice daily after meals for 4 weeks. Way of taking CHM granules is as follow: Add 100ml boiling water into a cup, then pour one pack of granules into the cup and soap it for 2-3 mins. Stir until the granules completely dissolve before drinking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose (FPG)
Time Frame: Baseline, week 2, week 4, week 8.
FPG will be determined by taking a blood sample from participants who have fasted for 8-12 hours.
Baseline, week 2, week 4, week 8.
Blood pressure
Time Frame: Baseline, week 2, week 4, week 8.
Blood pressure was measured thrice, after a 10 min rest, using a standard digital sphygmomanometer.
Baseline, week 2, week 4, week 8.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Framingham Stroke Risk Score (FSRS)
Time Frame: Baseline, week 2, week 4, week 8.
The Framingham Stroke Risk Score (FSRS) combines stroke risk factors (sex, age, systolic blood pressure, high-density lipoprotein level, total cholesterol level, smoking, diabetes) to predict 10-year probability of stroke.
Baseline, week 2, week 4, week 8.
Audit of diabetes-dependent quality of Life (ADDQoL)
Time Frame: Baseline, week 4, week 8.
The ADDQOL consists of two overview items; one measures generic overall QoL and a further 19 items are concerned with the impact of diabetes on specific aspects of life. The 19 life domains are as follows: leisure activities, working life, local or long-distance journeys, holidays, physical health, family life, friendships and social life, close personal relationships, sex life, physical appearance, self-confidence, motivation to achieve things, people's reactions, feelings about the future, financial situation, living conditions, dependence on others, freedom to eat, and freedom to drink. Lower scores reflect poorer QoL. Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains.
Baseline, week 4, week 8.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: Baseline, week 2, week 4, week 8.
IPAQ-SF has been recommended as a cost-effective method to assess physical activity. IPAQ-SF records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate- intensity activity such as leisure cycling, 3) walking, and 4) sitting. It requires participants to recall the number of days and time spent on different intensity of activities in last 7 day.
Baseline, week 2, week 4, week 8.
Anthropometric assessment, lipid panels, HbA1C
Time Frame: Baseline, week 2, week 4, week 8.
Anthropometric indices such as body height (BH), body weight (BW), waist circumference (WC) and hip circumference (HC) were measured. Body mass index [(BMI) = BW (kg)/BH (m)2] and waist-to-hip ratio [(WHR) = WC (cm)/HC (cm)] will be calculated. Lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) will be assessed before and after treatment period. Hemoglobin A1c test, as known as HbA1c, measure the amount of blood glucose attached to hemoglobin, indicating the average blood glucose level for the last two to three months. For diabetic patients, an ideal HbA1c level is 48mmol/mol (6.5%) or below.
Baseline, week 2, week 4, week 8.
Physiological parameters and dietary records
Time Frame: Baseline, week 2, week 4, week 8.
Wearable watch will be used to record patients' daily step count and physiological parameters. Patients' diet will be assessed by 3-day weighed dietary records (two non-consecutive weekdays and one weekend day).
Baseline, week 2, week 4, week 8.
Adverse events
Time Frame: Baseline, week 2, week 4, week 8.
All adverse events (AEs), defined as any adverse events that occur from the beginning of the participant's enrollment to the end of the trial, regardless of whether there is a causal relationship with the received treatments, that occur in the trial will be recorded.
Baseline, week 2, week 4, week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/23-24/0397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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