Type2 DiabetesPhase 1/2NCT04623567
Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances
A Phase 1/2 study testing Jiangtang Tiaozhi recipe and Metformin in people with Type2 Diabetes and Dyslipidemias, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes, Dyslipidemias
- What is being tested?
- Jiangtang Tiaozhi recipe and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 30 Jun 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years at the time of their consent;
- Diagnosed with type 2 diabetes;
- TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L;
- BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm;
- Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;
- TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome;
- Signed informed consent.
Who cannot join
- Type 1 diabetes, gestational diabetes, other special types of diabetes.
- Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.
- Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.
- Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc..
- Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.
- Pregnant, preparing for pregnancy or lactation.
- Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies.
- According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Weidong Li, +8601088001552, gamhec@126.com
About this study
Official title: Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances and Associations Study Between Glucose and Lipid Metabolism Disturbances and Cardiovascular Risk Factors
This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.
Read the detailed description
The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.
- Conditions
- Type2 Diabetes, Dyslipidemias
- Being tested
- Jiangtang Tiaozhi recipe, Metformin
- Keywords
- type 2 diabetes mellitus, dyslipidemias, Jiangtang Tiaozhi Recipe, randomized controlled trial
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiangtang Tiaozhi recipeDrug
The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
MetforminDrug
Also called Glucophage
The metformin tablets (500mg) will be administrated.
| Study group | Role | What they receive |
|---|---|---|
| Jiangtang Tiaozhi Recipe Group | Experimental | Jiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. Receives: Drug: Jiangtang Tiaozhi recipe |
| Metformin Group | Active comparator | 500mg metformin tablet per time, 3 times a day, take it with meals. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HbA1c at 12 weeks
Measured: 0 week, 12 weeks
Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks
Measured: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Postprandial Blood Glucose at 12 weeks
Measured: 0 week, 12 weeks
Change from Baseline Low Density Lipoprotein at 12 weeks
Measured: 0 week, 12 weeks
Change from Baseline Triglyceride at 12 weeks
Measured: 0 week, 12 weeks
Secondary outcomes (5)
Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks
Measured: 0 week, 4 weeks, 8 weeks,12 weeks
Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks
Measured: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Total Cholesterol at 12 weeks
Measured: 0 week, 12 weeks
Change from Baseline High Density Lipoprotein at 12 weeks
Measured: 0 week, 12 weeks
Change from Baseline TCM Symptom Score at 12 weeks
Measured: 0 week, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start22 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaxing Tian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiaxing Tian, PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623567
- Sponsor's protocol ID
- CD2020-4-4155
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu H, Fang X, Jin D, Miao R, Wei J, Zhao T, Dai D, Liao J, Wang J, Lian F, Tian J. Efficacy and Mechanism of the Jiangtang Tiaozhi Recipe in the Management of Type 2 Diabetes and Dyslipidaemia: A Clinical Trial Protocol. Front Pharmacol. 2022 Feb 4;13:827697. doi: 10.3389/fphar.2022.827697. eCollection 2022.
PubMed 35185579
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances and Associations Study Between Glucose and Lipid Metabolism Disturbances and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04623567
- Acronym / sponsor ID
- CD2020-4-4155
- Conditions
- Type2 Diabetes, Dyslipidemias
- Keywords
- type 2 diabetes mellitus, dyslipidemias, Jiangtang Tiaozhi Recipe, randomized controlled trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 10 Nov 2020 (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 is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.
Detailed description
The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jiangtang Tiaozhi Recipe Group | Experimental | Drug: Jiangtang Tiaozhi recipeJiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. |
| Metformin Group | Active comparator | Drug: Metformin500mg metformin tablet per time, 3 times a day, take it with meals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 70 years at the time of their consent;
- Diagnosed with type 2 diabetes;
- TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L;
- BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm;
- Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment;
Key exclusion criteria (8 listed)
- Type 1 diabetes, gestational diabetes, other special types of diabetes.
- Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases.
- Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month.
- Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc..
- Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts.
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 |
|---|---|---|
| Jiangtang Tiaozhi recipeThe Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7) | Drug | Jiangtang Tiaozhi Recipe Group |
| MetforminAlso: GlucophageThe metformin tablets (500mg) will be administrated. | Drug | Metformin Group |
Primary outcome
Change from Baseline HbA1c at 12 weeks
Time frame: 0 week, 12 weeks
Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Postprandial Blood Glucose at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline Low Density Lipoprotein at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline Triglyceride at 12 weeks
Time frame: 0 week, 12 weeks
5 secondary outcomes
Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Total Cholesterol at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline High Density Lipoprotein at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline TCM Symptom Score at 12 weeks
Time frame: 0 week, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 35185579Wu H, Fang X, Jin D, Miao R, Wei J, Zhao T, Dai D, Liao J, Wang J, Lian F, Tian J. Efficacy and Mechanism of the Jiangtang Tiaozhi Recipe in the Management of Type 2 Diabetes and Dyslipidaemia: A Clinical Trial Protocol. Front Pharmacol. 2022 Feb 4;13:827697. doi: 10.3389/fphar.2022.827697. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jiaxing Tian, PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Jiangtang Tiaozhi recipe and Metformin in people with Type2 Diabetes and Dyslipidemias, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 7 inclusion and 8 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 18 Sep 2023. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jiaxing Tian, PhD (+8601088001166, tina_yai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HbA1c at 12 weeks (time frame: 0 week, 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623567, which also lists 1 linked publication.
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 18 Sep 2023.