Type 2 Diabetes MellitusEarly Phase 1NCT03010241
The Multi-Centric Clinical Study of Chinese Medicine Intervention on Diabetes Distal Symmetric Polyneuropathy.
A Early Phase 1 study testing Tangbi (prescription) in people with Type 2 Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2 diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than 60% of the amputations of the lower limbs… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tangbi (prescription)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2020
- Phase
- Early Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of diabetic distal symmetric polyneuropathy;
- The patient's age is between 30-70 years;
- Sign informed consent
Who cannot join
- Recent use of antioxidants such as vitamin E or vitamin C, acute infection, liver and kidney dysfunction, acute complications of diabetes, severe cardiovascular and cerebrovascular diseases, neuropathy caused by long-term alcohol consumption and other factors.
- Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary disease, serum transaminase beyond the normal value more than 2 times, serum creatinine greater than the upper limit of normal, psychiatric patients.
- Pregnancy, prepared to pregnant or lactating women, or having a history of drug allergy.
- Participate in other drug clinical within one month.
- Systolic blood pressure> 160mmHg or diastolic blood pressure> 100mmHg.
- Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.
- Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and dependents over the past five years.
- Having other diseases or conditions may reduce the possibility of entry or complicate the entry according to the researchers' judgement, such as the working environment changes frequently, unstable living environment etc., what is easy to cause loss of contact.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy
Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2 diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than 60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We postulate that patients with DSPN will benefit from therapy with TCM treatment according to syndrome differentiation.
Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Tangbi prescription, and the patients in the control group were treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication. Secondary Evaluation Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.② Clinical symptoms and signs change, The clinical symptoms and signs of the patients were compared before and after taking the medicine.
Discussion: We postulate that patients with DSPN will benefit from therapy with TCM treatment.
Read the detailed description
- Purpose of the study Major objective: To evaluate the efficacy of traditional Chinese medicine (Tangbi prescription) in improving the clinical symptoms of patients with diabetic distal symmetric polyneuropathy. Secondary objective: To evaluate the effect of traditional Chinese medicine (Tangbi prescription) on nerve conduction velocity of patients with diabetic distal symmetric polyneuropathy.
- Experimental Measures and contrast A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. The patients in the study group were treated with Tangbi prescription (1 dose / day, twice), and patients were treated with placebo (1 dose / day, twice) in the control group. Treatment was scheduled for 24 weeks. The sample size was determined to 188 cases through statistics calculation. Sample size calculation basis: According to the preliminary study of Antang-tongbi prescription data, placebo group scale (Toronto TCSS scale) score difference is 3.45, while Tangbi prescription scale score was 4.14, and the public standard deviation s = 1.33. The sample size is estimated by hypothesis test formula of measurement data: N = 2 * [(Zα + Zβ) * δ / d] ^ 2 (pp. 112-113 of the third edition of Epidemiology) (n is the sample size and σ is the estimated standard deviation, d is two groups' continuous variable mean difference; Zα and Zβ are the corresponding standard normal differences; for Zα and Zβ values, see the Human Health Edition, Epidemiology, Third Edition, page 73, Table 6.2). Supposing= 0.05, β = 0.10, according to one-sided check table, the quantile Zα = 1.64485, Zβ = 0.84162, and put them into the formula, and result was n = 78.10. Therefore, each group needs 78 patients. Considering no more than 20% withdrawal rate, the total number of cases is 188, of 94 cases in each group.
- Bias analysis The evaluation index of this study is clinical symptoms, affected by many factors. Although there are many ways in the treatment of oral drugs, but the exact evidence of evidence-based medicine is not proved. Therefore, there is little factor impacting of the biases of the evaluation results, concluding the following aspects: (1) blood glucose levels. (2) existing treatment measures, (3) the conditions of EMG determination. These influencing factors are addressed as follows: (1) As for blood glucose levels factor, a randomized, double-blind study design approach was used to ensure consistency of the factor in the two groups. (2) subjects taking Methycobal can reduce the psychological effect of patients on the efficacy of curative effect and increase patient compliance. (3) Train EMG doctors consistently, and the EMG determination is fixed, which forms the SOP of this study.
- Research design 4.1 The design scheme A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Antang-tongbi prescription, and the patients in the control group were treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases. 4.2 Research Period Medication cycle is 24 weeks. 4.3 curative effect evaluation criteria 4.3.1 Major evaluation indicators Changes in Clinical Symptoms and Signs in Distal Symmetrical Polyneuropathy patients. The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication. 4.3.2 Secondary Evaluation Indicators ① nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine. ② Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine. 4.4 Curative effect observation indicators ① Nerve conduction velocity (every 6 months).
- MDNS scale (every 3 months). 4.5 Observational Indicators ① Background observation (0 weeks)
- Demographic data: gender, age, height, weight and so on.
- General clinical data: medical history, course of the disease, treatment history, combined disease and medication.
- Diagnostic and monitoring indicators
- Blood pressure, fasting blood glucose test (every 1 month).
- Glycated hemoglobin, blood lipids (every 3 months). 4.6 Analysis of relevant measures are based on bias analysis 4.7 Basic treatment ① Diabetes education;
- Diabetic diet;
- Rational control of blood glucose: use oral hypoglycemic agents or insulin injections to keep all patients blood glucose stable in the study. In principle, the type and dose of hypoglycemic agents should maintain unchanged. If fasting blood glucose fluctuates more than 20%, diabetes experts were needed to find and remove the predisposing factors as soon as possible, and adjust the dose and monitor blood glucose changes, so the blood glucose can be smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in the combined medication table. ④ Taking Mecobalamin tablets (1 / time, 3 times / day). (Eisai (China) Pharmaceutical Co., Ltd.) 4.8 Provisions for combined treatment
- All Chinese herbal medicines with the same efficacy as the study drug (including Chinese herbal medicines with similar therapeutic indications and Chinese herbal medicines with similar efficacy) were banned during the study period.
- All combination therapy and treatment (treatment measure or treatment medicine of other diseases) should be documented in the combined medication table.
- Besides Methycobal, drugs for the treatment of diabetic peripheral neuropathy are prohibited, including α-lipoic acid, epalrestat, VitB12 and so on.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tangbi (prescription), Placebo
- Keywords
- Diabetes Distal Symmetric Polyneuropathy, Chinese medicine
- 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.
Tangbi (prescription)Drug
Also called Tang bi fang
A kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
PlaceboDrug
Also called Placebos
Granule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste.
Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
| Study group | Role | What they receive |
|---|---|---|
| Tangbi Prescription | Experimental | Based on the standard medical care, experimental group were treated with Tangbi Prescription 4.87g granules, 2 times/d, which The prescripton was composed by five Chinese herbal medicines. Receives: Drug: Tangbi (prescription) |
| Placebo | Placebo comparator | Based on the standard medical care, placebo-controlled group were treated with Placebo 4.87g granules, 2 times/d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication
Measured: Month 0, Month 3, Month 6
Secondary outcomes (2)
nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.
Measured: Month 0, Month 6
Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine.
Measured: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2019 (estimated)
- Study completionMay 2020 (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 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Zhengzhou City Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Hebei Yiling Hospital, Hubei Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010241
- Sponsor's protocol ID
- 2016Tangbi Prescription
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jin D, Huang WJ, Meng X, Yang F, Zheng YJ, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial. Trials. 2017 Dec 29;18(1):631. doi: 10.1186/s13063-017-2345-1.
PubMed 29284520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy
- ClinicalTrials.gov ID
- NCT03010241
- Acronym / sponsor ID
- 2016Tangbi Prescription
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Distal Symmetric Polyneuropathy, Chinese medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Zhengzhou City Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Hebei Yiling Hospital, Hubei Hospital of Traditional Chinese Medicine
- Study start
- Jan 2017
- Primary completion
- Nov 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Jan 2017 (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.
Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2 diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than 60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We postulate that patients with DSPN will benefit from therapy with TCM treatment according to syndrome differentiation.
Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Tangbi prescription, and the patients in the control group were treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication. Secondary Evaluation Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.② Clinical symptoms and signs change, The clinical symptoms and signs of the patients were compared before and after taking the medicine.
Discussion: We postulate that patients with DSPN will benefit from therapy with TCM treatment.
Detailed description
- Purpose of the study Major objective: To evaluate the efficacy of traditional Chinese medicine (Tangbi prescription) in improving the clinical symptoms of patients with diabetic distal symmetric polyneuropathy. Secondary objective: To evaluate the effect of traditional Chinese medicine (Tangbi prescription) on nerve conduction velocity of patients with diabetic distal symmetric polyneuropathy.
- Experimental Measures and contrast A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. The patients in the study group were treated with Tangbi prescription (1 dose / day, twice), and patients were treated with placebo (1 dose / day, twice) in the control group. Treatment was scheduled for 24 weeks. The sample size was determined to 188 cases through statistics calculation. Sample size calculation basis: According to the preliminary study of Antang-tongbi prescription data, placebo group scale (Toronto TCSS scale) score difference is 3.45, while Tangbi prescription scale score was 4.14, and the public standard deviation s = 1.33. The sample size is estimated by hypothesis test formula of measurement data: N = 2 * [(Zα + Zβ) * δ / d] ^ 2 (pp. 112-113 of the third edition of Epidemiology) (n is the sample size and σ is the estimated standard deviation, d is two groups' continuous variable mean difference; Zα and Zβ are the corresponding standard normal differences; for Zα and Zβ values, see the Human Health Edition, Epidemiology, Third Edition, page 73, Table 6.2). Supposing= 0.05, β = 0.10, according to one-sided check table, the quantile Zα = 1.64485, Zβ = 0.84162, and put them into the formula, and result was n = 78.10. Therefore, each group needs 78 patients. Considering no more than 20% withdrawal rate, the total number of cases is 188, of 94 cases in each group.
- Bias analysis The evaluation index of this study is clinical symptoms, affected by many factors. Although there are many ways in the treatment of oral drugs, but the exact evidence of evidence-based medicine is not proved. Therefore, there is little factor impacting of the biases of the evaluation results, concluding the following aspects: (1) blood glucose levels. (2) existing treatment measures, (3) the conditions of EMG determination. These influencing factors are addressed as follows: (1) As for blood glucose levels factor, a randomized, double-blind study design approach was used to ensure consistency of the factor in the two groups. (2) subjects taking Methycobal can reduce the psychological effect of patients on the efficacy of curative effect and increase patient compliance. (3) Train EMG doctors consistently, and the EMG determination is fixed, which forms the SOP of this study.
- Research design 4.1 The design scheme A randomized, double-blind, placebo-controlled and multi-centric clinical trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Antang-tongbi prescription, and the patients in the control group were treated with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases. 4.2 Research Period Medication cycle is 24 weeks. 4.3 curative effect evaluation criteria 4.3.1 Major evaluation indicators Changes in Clinical Symptoms and Signs in Distal Symmetrical Polyneuropathy patients. The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication. 4.3.2 Secondary Evaluation Indicators ① nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine. ② Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine. 4.4 Curative effect observation indicators ① Nerve conduction velocity (every 6 months).
- MDNS scale (every 3 months). 4.5 Observational Indicators ① Background observation (0 weeks)
- Demographic data: gender, age, height, weight and so on.
- General clinical data: medical history, course of the disease, treatment history, combined disease and medication.
- Diagnostic and monitoring indicators
- Blood pressure, fasting blood glucose test (every 1 month).
- Glycated hemoglobin, blood lipids (every 3 months). 4.6 Analysis of relevant measures are based on bias analysis 4.7 Basic treatment ① Diabetes education;
- Diabetic diet;
- Rational control of blood glucose: use oral hypoglycemic agents or insulin injections to keep all patients blood glucose stable in the study. In principle, the type and dose of hypoglycemic agents should maintain unchanged. If fasting blood glucose fluctuates more than 20%, diabetes experts were needed to find and remove the predisposing factors as soon as possible, and adjust the dose and monitor blood glucose changes, so the blood glucose can be smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in the combined medication table. ④ Taking Mecobalamin tablets (1 / time, 3 times / day). (Eisai (China) Pharmaceutical Co., Ltd.) 4.8 Provisions for combined treatment
- All Chinese herbal medicines with the same efficacy as the study drug (including Chinese herbal medicines with similar therapeutic indications and Chinese herbal medicines with similar efficacy) were banned during the study period.
- All combination therapy and treatment (treatment measure or treatment medicine of other diseases) should be documented in the combined medication table.
- Besides Methycobal, drugs for the treatment of diabetic peripheral neuropathy are prohibited, including α-lipoic acid, epalrestat, VitB12 and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tangbi Prescription | Experimental | Drug: Tangbi (prescription)Based on the standard medical care, experimental group were treated with Tangbi Prescription 4.87g granules, 2 times/d, which The prescripton was composed by five Chinese herbal medicines. |
| Placebo | Placebo comparator | Drug: PlaceboBased on the standard medical care, placebo-controlled group were treated with Placebo 4.87g granules, 2 times/d |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the diagnostic criteria of diabetic distal symmetric polyneuropathy;
- The patient's age is between 30-70 years;
- Sign informed consent
Key exclusion criteria (8 listed)
- Recent use of antioxidants such as vitamin E or vitamin C, acute infection, liver and kidney dysfunction, acute complications of diabetes, severe cardiovascular and cerebrovascular diseases, neuropathy caused by long-term alcohol consumption and other factors.
- Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary disease, serum transaminase beyond the normal value more than 2 times, serum creatinine greater than the upper limit of normal, psychiatric patients.
- Pregnancy, prepared to pregnant or lactating women, or having a history of drug allergy.
- Participate in other drug clinical within one month.
- Systolic blood pressure> 160mmHg or diastolic blood pressure> 100mmHg.
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 |
|---|---|---|
| Tangbi (prescription)Also: Tang bi fangA kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013). | Drug | Tangbi Prescription |
| PlaceboAlso: PlacebosGranule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste. Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013). | Drug | Placebo |
Primary outcome
The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication
Time frame: Month 0, Month 3, Month 6
2 secondary outcomes
nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.
Time frame: Month 0, Month 6
Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine.
Time frame: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 29284520Jin D, Huang WJ, Meng X, Yang F, Zheng YJ, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial. Trials. 2017 Dec 29;18(1):631. doi: 10.1186/s13063-017-2345-1.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tangbi (prescription) in people with Type 2 Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 3 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 De JIN, Master (13681514368, 826901274@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication (time frame: Month 0, Month 3, Month 6). 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 NCT03010241, 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 5 Jan 2017.