Type 2 Diabetes MellitusNCT01844050
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
A study testing Chinese herbal medicine in people with Type 2 Diabetes Mellitus, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Chinese herbal medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Oct 2009
- 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
- Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
- After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
- Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
- Subject is willing to participate and capable of giving informed consent.
Who cannot join
- Those patients used any drugs for treatment of diabetes within one month.
- Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
- Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
- Women who were pregnant, lactating or planned pregnant.
- Allergic constitution and has a history of drug allergy.
- Combined with severe acute or chronic infections.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201108
About this study
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Chinese herbal medicine, Placebo
- Keywords
- Chinese herbal medicine, diabetes symptoms
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicineDrug
According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine | Experimental | Individualized Treatment with Chinese herbal Receives: Drug: Chinese herbal medicine |
| Placebo | Placebo comparator | Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Total score of diabetes symptoms at 4 weeks
Measured: 0 weeks(baseline), 2 weeks, 4 weeks
Secondary outcomes (2)
Change from Baseline Fasting Blood Glucose at 4 weeks
Measured: 0 weeks(baseline), 2 weeks, 4 weeks
Change from Baseline blood glucose at 2 hours after meal at 4 weeks
Measured: 0 weeks(baseline), 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Putuo District Center Hospital
- Responsible party
- Sponsor
- Investigators
- Kaixian Chen, Ph.D, Study chair, Shanghai Universitu of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844050
- Sponsor's protocol ID
- 06DZ19728-2
- Other IDs
- S06DZ19728
- Status last verified
- May 2013
- First submitted
- 22 Apr 2013
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms
- ClinicalTrials.gov ID
- NCT01844050
- Acronym / sponsor ID
- 06DZ19728-2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Chinese herbal medicine, diabetes symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Putuo District Center Hospital
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 May 2013 (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.
Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine | Experimental | Drug: Chinese herbal medicineIndividualized Treatment with Chinese herbal |
| Placebo | Placebo comparator | Drug: PlaceboIndividualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
- After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l<2h PG<16mmol/l
- Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
- Subject is willing to participate and capable of giving informed consent.
Key exclusion criteria (6 listed)
- Those patients used any drugs for treatment of diabetes within one month.
- Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
- Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
- Women who were pregnant, lactating or planned pregnant.
- Allergic constitution and has a history of drug allergy.
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 |
|---|---|---|
| Chinese herbal medicineAccording to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation. | Drug | Chinese herbal medicine |
| Placebo | Drug | Placebo |
Primary outcome
Change from Baseline Total score of diabetes symptoms at 4 weeks
Time frame: 0 weeks(baseline), 2 weeks, 4 weeks
2 secondary outcomes
Change from Baseline Fasting Blood Glucose at 4 weeks
Time frame: 0 weeks(baseline), 2 weeks, 4 weeks
Change from Baseline blood glucose at 2 hours after meal at 4 weeks
Time frame: 0 weeks(baseline), 2 weeks, 4 weeks
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 12 Jun 2019.
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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.
Kaixian Chen, Ph.D study chair
Shanghai Universitu of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicine in people with Type 2 Diabetes Mellitus, run by Shanghai University of Traditional Chinese Medicine 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 4 inclusion and 6 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 12 Jun 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 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. 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?
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?
Change from Baseline Total score of diabetes symptoms at 4 weeks (time frame: 0 weeks(baseline), 2 weeks, 4 weeks). 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 12 Jun 2019.