Accidental Exposure While Preparing Drug for AdministrationPhase 1/2TNTLNCT02161276
Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule
A Phase 1/2 study testing TNTL capsule in people with Accidental Exposure While Preparing Drug for Administration, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 1 site in China.
Trial summary
Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Accidental Exposure While Preparing Drug for Administration
- What is being tested?
- TNTL capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Sep 2014
- 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
- Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
- Age between 18-70 years.
- The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%.
- Traditional Chinese medicine symptom score ≥ 4 points.
- Participated in the experiment voluntarily, and signed the informed consent form.
Who cannot join
- Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
- Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine.
- Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
- ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
- Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
- Pregnant, lactating women and prepare for pregnancy.
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- The allergic constitution and the drug allergy known composition.
- For nearly a month with severe infection or other emergency state, such as trauma, operation etc..
- within the past 3 months, participated in the other drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes
Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.
aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus.
---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes
Read the detailed description
Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.
- Being tested
- TNTL capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNTL capsuleDrug
Also called Tang Ning Tongluo Capsule
Patients were asked to taken drugs 3 times a day, with each time 3 grains
PlaceboDrug
Patients were asked to taken drugs 3 times a day, with each time 3 grains
| Study group | Role | What they receive |
|---|---|---|
| TNTL capsule and Placebo | Experimental | 3-4 capsules 3 times a day Used before meals Receives: Drug: TNTL capsule; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decline glycosylated hemoglobin A1C and blood glucose level
Decline in Hemoglobin A1C and blood glucose level
Measured: up to 8 weeks
Secondary outcomes (1)
The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants
Routine check for blood, urine, stool + occult blood, liver function (ALT, AST, AKP, GGT, TBIL), renal function (BuN, Cr), ECG before treatment with 1 times per week.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Exposure While Preparing Drug for AdministrationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- XY Xin, Dr., Study director, ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161276
- Sponsor's protocol ID
- TNTL-14-01
- Acronym
- TNTL
- Status last verified
- Sep 2014
- First submitted
- 21 May 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of The Optimal Dosage of Tang Ning Tongluo Capsule for Type II Diabetes
- ClinicalTrials.gov ID
- NCT02161276
- Acronym / sponsor ID
- TNTL / TNTL-14-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jun 2014 (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.
Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.
aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule to treat type II diabetes mellitus.
---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes
Detailed description
Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning Tongluo capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNTL capsule and Placebo | Experimental | Drug: TNTL capsule, Drug: Placebo3-4 capsules 3 times a day Used before meals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfilled diagnostic criteria for type II diabetes and TCM syndrome diagnostic criteria.
- Age between 18-70 years.
- The blood sugar meet the following criteria: fasting blood glucose ≥ 7.0mmol/L, ≤ 13 mmol/L and (or) ≥ 2 hour postprandial blood glucose 11.1 mmol/L, ≤ 16 mmol/L; eligible conditions in blood glucose, glycosylated hemoglobin to ≤ 10%.
- Traditional Chinese medicine symptom score ≥ 4 points.
- Participated in the experiment voluntarily, and signed the informed consent form.
Key exclusion criteria (9 listed)
- Durring the cleaning period, blood sugar dropped to below detection diagnosis value through diet, increasing activity.
- Secondary diabetes mellitus or nearly a month using insulin; or is the use of insulin sensitizers (thiazolidine two ketones), repaglinide, Bernard Glenn Nai, alpha glucoside enzyme inhibitor (acarbose, voglibose), other traditional Chinese medicine.
- Within the past 1 months, with diabetic ketoacidosis and other acute metabolic disorders.
- ALT is 2 times higher than the upper limit of the normal value, Cr is higher than the upper limit of normal persons.
- Has severe heart, liver, renal, hematopoietic system disease, or other serious diseases and mental disease patients.
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 |
|---|---|---|
| TNTL capsuleAlso: Tang Ning Tongluo CapsulePatients were asked to taken drugs 3 times a day, with each time 3 grains | Drug | TNTL capsule and Placebo |
| PlaceboPatients were asked to taken drugs 3 times a day, with each time 3 grains | Drug | TNTL capsule and Placebo |
Primary outcome
The decline glycosylated hemoglobin A1C and blood glucose level
Time frame: up to 8 weeks
Decline in Hemoglobin A1C and blood glucose level
1 secondary outcome
The clinical composite safety evaluation of Tangning Tongluo Capsule in the treatment of type II diabetes participants
Time frame: 2 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 11 Sep 2014.
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.
XY Xin, Dr. study director
ICMJE
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 TNTL capsule in people with Accidental Exposure While Preparing Drug for Administration, run by Guizhou Bailing Group Pharmaceutical Co Ltd 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 5 inclusion and 9 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 11 Sep 2014. 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?
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?
The decline glycosylated hemoglobin A1C and blood glucose level (time frame: up to 8 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 11 Sep 2014.