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Diabetes Mellitus, Type 2Phase 4NCT05095922

Effect of HMP on Diabetic Microangiopaemia in T2DM

A Phase 4 study testing Heart-Protecting Musk Pill, Valsartan Capsules and Calcium Dobesilate Capsules in people with Diabetes Mellitus, Type 2 and Diabetic Angiopathies, run by Affiliated Hospital of Nantong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study mainly investigates the therapeutic effect of Heart-Protecting Musk Pill (HMP) on patients with diabetic microangiopathy. According to the indicators of diabetic nephropathy (DN), diabetic retinopathy (DR), oxidative stress and inflammatory factor in patients with diabetic microvascular disease after using… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Heart-Protecting Musk Pill, Valsartan Capsules and Calcium Dobesilate Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
28 Mar 2023to 30 May 2024
Phase
Phase 4
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Diabetes mellitus
  • Prescribed for Valsartan Capsules and Calcium Dobesilate Capsules

Who cannot join

  • Type 1 diabetes mellitus
  • Secondary diabetes
  • Malignant tumors
  • Active infection
  • Acute diabetic complications
  • Macrovascular complications
Show all 11Show fewer
  • Mental illness
  • Intellectual disability
  • Impaired heart function
  • Impaired liver function
  • Impaired kidney function

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226000

Other trials in China

About this study

Official title: Effect of Heart-Protecting Musk Pill on Diabetic Microangiopaemia in Type 2 Diabetes Patients

The study mainly investigates the therapeutic effect of Heart-Protecting Musk Pill (HMP) on patients with diabetic microangiopathy. According to the indicators of diabetic nephropathy (DN), diabetic retinopathy (DR), oxidative stress and inflammatory factor in patients with diabetic microvascular disease after using HMP, the investigators aim to evaluate the effect of HMP on diabetic microangiopathy, oxidative stress and inflammation.

Read the detailed description

Diabetes can lead to many diseases as diabetic macrovascular and microvascular complications which result in high disability and mortality rate, thereby seriously affecting the quality of life and life expectancy of diabetic patients. It not only aggravates the family burden of patients, but also becomes the main burden of public health services around the world.

Diabetic nephropathy (DN) and diabetic retinopathy (DR) are more serious in diabetic microangiopathy. The glomerulus and retina have the similar tissue structure and physiological function. Therefore, when they are exposured to the same risk factors can lead to microcirculation damage of kidney and retina. DN and DR have similar pathogenesis and development processes. Although the susceptibility genes and cytokines of DN and DR are different, the two can still be predictors of each other and they often coexist in diabetic patients.

At present, there are few drugs with definite curative effect on the treatment of diabetic microangiopathy, therefore the treatment of diabetic microangiopathy is an aspect that urgently needs a breakthrough in chronic complications of diabetes. Traditional Chinese medicine has a history of preventing and treating diabetes for thousands of years. For the treatment of chronic complications of diabetes by Chinese medicine, although there are not many Chinese medicines that have obtained curative effects, it has indeed accumulated rich experience in the process of research and clinical treatment that Western medicine could not obtain. Therefore, seeking Chinese medicine to effectively treat diabetic microvascular disease has become a direction worthy of attention and research.

Heart-Protecting Musk Pill (HMP) is a commonly used drug in clinical treatment, which comprises seven medicinal substances: Radix Ginseng, Venenum Bufonis, Styrax, Calculus Bovis Artifactus, Cortex Cinnamomi, Borneolum Syntheticum and Artificial Moschus. HMP is a traditional Chinese medicinal compound, which has been effectively used for treating coronary heart disease (CHD) and diabetic macrovascular disease. However, studies on Chinese medicines that are partially similar to HMP have shown that they can improve diabetic retinopathy. Therefore, the study of the efficacy of HMP on diabetic microangiopathy is extremely valuable. Previous researches have shown that HMP owns the effects of reducing oxidative stress, improving inflammation, anti-plateleting aggregation, promoting plasmin activity, and improving hemodynamics. It is possible that HMP can delay or improve the occurrence and development of diabetic microangiopathy through the above effects and even other unclear mechanisms.

At present, the drugs used for clinical treatment of type 2 diabetic microangiopathy are limited. Although the pharmacological indications of HMP can be used to deal with the pathogenesis of diabetic microvascular complications, there is still no clinical study of HMP for the treatment of diabetic microvascular complications. Therefore, this study compared the differences in indicators related to diabetic nephropathy, diabetic retinopathy, oxidative stress, and inflammatory factors between the control group and the HMP group before and after treatment to clarify the therapeutic effect of HMP on diabetic microangiopaemia.

Being tested
Heart-Protecting Musk Pill, Valsartan Capsules, Calcium Dobesilate Capsules
Keywords
Heart-protecting musk pill, type 2 diabetes, diabetic angiopathies
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Angiopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart-Protecting Musk PillDrug

    Also called Heart-Protecting Musk Pill，National Medicine Permission Number Z31020068，86900674000453

    Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)

  • Valsartan CapsulesDrug

    Also called Valsartan Capsules，National Medicine Permission Number H20040217，86900100000095

    Valsartan Capsules(capsule, 80mg, once a day, 3 months）

  • Calcium Dobesilate CapsulesDrug

    Also called Doxium，H20140641

    Calcium Dobesilate Capsules(capsule, 500mg, three times a day, 3 months)

Study groups in NCT05095922
Study groupRoleWhat they receive
Heart-Protecting Musk Pill groupExperimentalHeart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)+Valsartan Capsules(capsule, 80mg, once a day, 3 months）+Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)
Receives: Drug: Heart-Protecting Musk Pill; Drug: Valsartan Capsules; Drug: Calcium Dobesilate Capsules
Control groupPlacebo comparatorValsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)
Receives: Drug: Valsartan Capsules; Drug: Calcium Dobesilate Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of biochemical Indicators

    Total cholesterol(TC), Triglycerides(TG), High-density lipoprotein cholesterol(HDL-C), Low-density lipoprotein cholesterol(LDL-C), Fasting blood glucose(FBG), Blood urea nitrogen(BUN)

    Measured: Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months

  2. Concentration of Glycosylated hemoglobin

    Glycosylated hemoglobin(HbA1c)

    Measured: Change from Baseline HbA1c at 3 months

  3. Concentration of hypersensitive-c-reactive-protein and Cystatin C

    hypersensitive-c-reactive-protein(hs-CRP), Cystatin C(CysC)

    Measured: Change from Baseline hs-CRP and CysC at 3 months

  4. Concentration of Serum creatinine

    Serum creatinine(Scr)

    Measured: Change from Baseline Scr at 3 months

  5. Rate of estimated Glomerular Filtration

    estimated Glomerular Filtration Rate(eGFR)

    Measured: Change from Baseline eGFR at 3 months

  6. Ratio of Urinary albumin to creatinine

    Urinary albumin to creatinine Ratio(UACR)

    Measured: Change from Baseline UACR at 3 months

  7. Concentration of Serum fatty acid binding protein 4

    Serum fatty acid binding protein 4（FABP4)

    Measured: Change from Baseline FABP4 at 3 months

  8. Indicators of diabetic retinopathy

    The vision and fundus photography will be checked by an ophthalmologist to determine the effect.

    Measured: Change from Baseline effect at 3 months

  9. Concentration of inflammation indicator

    Tumor Necrosis Factor-α(TNF-α)

    Measured: Change from Baseline TNF-α at 3 months

  10. Concentration of inflammation indicator

    Vascular Endothelial Growth Factor(VEGF)

    Measured: Change from Baseline VEGF at 3 months

  11. Concentration of inflammation indicator

    CC chemokine ligand 3(CCL3)

    Measured: Change from Baseline CCL3 at 3 months

  12. Concentration of Oxidative stress indicator

    Superoxide dismutase(SOD)

    Measured: Change from Baseline SOD at 3 months

  13. Concentration of Oxidative stress indicator

    Glutathione peroxidase(GSH-Px)

    Measured: Change from Baseline GSH-Px at 3 months

  14. Concentration of Oxidative stress indicator

    Reactive oxygen species(ROS）

    Measured: Change from Baseline ROS at 3 months

  15. Clinical characteristics

    Height, Waistline

    Measured: Change from Baseline Height, Waistline at 3 months

  16. Clinical characteristic

    Weight

    Measured: Change from Baseline Weight at 3 months

  17. Blood pressure

    Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP)

    Measured: Change from Baseline SBP, DBP at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start28 Mar 2023
  3. Primary completion30 May 2024
  4. Study completion30 May 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The type 2 diabetes subjects with diabetic microangiopathy
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05095922
Sponsor's protocol ID
HMP2008007p
Status last verified
Dec 2023
First submitted
28 Sep 2021
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BE, Klein R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010 Aug 11;304(6):649-56. doi: 10.1001/jama.2010.1111.

    PubMed 20699456

  • Geraldes P, King GL. Activation of protein kinase C isoforms and its impact on diabetic complications. Circ Res. 2010 Apr 30;106(8):1319-31. doi: 10.1161/CIRCRESAHA.110.217117.

    PubMed 20431074

  • Deng X, Sun L, Lai X, Xiang L, Li Q, Zhang W, Zhang L, Sun S. Tea Polypeptide Ameliorates Diabetic Nephropathy through RAGE and NF-kappaB Signaling Pathway in Type 2 Diabetes Mice. J Agric Food Chem. 2018 Nov 14;66(45):11957-11967. doi: 10.1021/acs.jafc.8b04819. Epub 2018 Nov 1.

    PubMed 30354109

  • Lu L, Qin Y, Chen C, Zhang X, Xu X, Lv C, Wan X, Ruan W, Guo X. The atheroprotective roles of heart-protecting musk pills against atherosclerosis development in apolipoprotein E-deficient mice. Ann Transl Med. 2019 Dec;7(23):714. doi: 10.21037/atm.2019.12.22.

    PubMed 32042730

  • Fan X, Shi M, Wang Y, Liang Q, Luo G. Transcriptional profiling analysis of HMP-treated rats with experimentally induced myocardial infarction. J Ethnopharmacol. 2011 Sep 1;137(1):199-204. doi: 10.1016/j.jep.2011.05.010. Epub 2011 May 13.

    PubMed 21605651

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Heart-Protecting Musk Pill, Valsartan Capsules and Calcium Dobesilate Capsules in people with Diabetes Mellitus, Type 2 and Diabetic Angiopathies, run by Affiliated Hospital of Nantong University 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 2 inclusion and 11 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 9 Jul 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Concentration of biochemical Indicators (time frame: Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months). The study lists 17 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 NCT05095922, which also lists 5 linked publications.

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 9 Jul 2024.

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