General Disorders and Administration Site ConditionsPhase 2NCT02174042
The Effect of Tang Ning Tongluo Formula in Type 2 Diabetics Clinical Analysis
A Phase 2 study testing Tangning Tongluo Capsule in people with General Disorders and Administration Site Conditions, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 1 site in China.
Trial summary
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- General Disorders and Administration Site Conditions
- What is being tested?
- Tangning Tongluo Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Sep 2014
- Phase
- Phase 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
- diagnosis of type 2 diabetes for more than one year.
- the sustained follow-up time >3 month.
- TNTL single or combined treatment time >3 month.
- Chinese ethnicity.
Who cannot join
- the medical record information is not original and available.
- lactating or pregnant.
- diagnosis of heart failure, acute myocardial infarction, stroke, or serious injuries.
- any other conditions not suitable for trial as evaluated by the physician in charge.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanmeng Tianyuan hospital; Dongfang Hospital; China-Japanese Friendship Hospital
Beijing Shi, Guizhou, 510000
About this study
Official title: The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule.
Read the detailed description
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.
- Being tested
- Tangning Tongluo Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tangning Tongluo CapsuleDrug
Also called TNTL Capsule
Taken drugs 3 times a day, with each time 3 grains
| Study group | Role | What they receive |
|---|---|---|
| Tangning Tongluo Capsule | Experimental | Type 2 diabetes Receives: Drug: Tangning Tongluo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline
The Changing (%) of Blood Glucose Level (mmol/L) and Glycosylated Hemoglobin Level (%) from Baseline (start using Tang Ning Tong Luo capsule) in recruited Type 2 diabetes patients.
Measured: At least 3 months
Secondary outcomes (1)
The Number of Participants with Adverse Events Using Tangning Tongluo Capsule
The Number of Participants with Adverse Events Using Tangning Tongluo Capsule in the Treatment ofType II Diabetes
Measured: At least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 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 General Disorders and Administration Site ConditionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenshu Teng, Dr., Study director, ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174042
- Sponsor's protocol ID
- TNTL-14-03
- Status last verified
- Sep 2014
- First submitted
- 23 Jun 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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
- The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis
- ClinicalTrials.gov ID
- NCT02174042
- Acronym / sponsor ID
- TNTL-14-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 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.
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule.
Detailed description
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tangning Tongluo Capsule | Experimental | Drug: Tangning Tongluo CapsuleType 2 diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of type 2 diabetes for more than one year.
- the sustained follow-up time >3 month.
- TNTL single or combined treatment time >3 month.
- Chinese ethnicity.
Key exclusion criteria (4 listed)
- the medical record information is not original and available.
- lactating or pregnant.
- diagnosis of heart failure, acute myocardial infarction, stroke, or serious injuries.
- any other conditions not suitable for trial as evaluated by the physician in charge.
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 |
|---|---|---|
| Tangning Tongluo CapsuleAlso: TNTL CapsuleTaken drugs 3 times a day, with each time 3 grains | Drug | Tangning Tongluo Capsule |
Primary outcome
The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline
Time frame: At least 3 months
The Changing (%) of Blood Glucose Level (mmol/L) and Glycosylated Hemoglobin Level (%) from Baseline (start using Tang Ning Tong Luo capsule) in recruited Type 2 diabetes patients.
1 secondary outcome
The Number of Participants with Adverse Events Using Tangning Tongluo Capsule
Time frame: At least 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 11 Sep 2014.
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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.
Wenshu Teng, 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 2 study testing Tangning Tongluo Capsule in people with General Disorders and Administration Site Conditions, 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 4 inclusion and 4 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 phase mean?
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 Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline (time frame: At least 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 11 Sep 2014.