Oral Chinese Herbal Medicine plus usual care for diabetic kidney disease: study protocol for a randomized, double-blind, placebo-controlled pilot trial Article Swipe
Meifang Liu
,
Yuan Ming Di
,
Lei Zhang
,
Lihong Yang
,
Zhang La
,
Junhui Chen
,
Ruobing Wang
,
Xiaoning Xie
,
Fang Lan
,
Liping Xie
,
Juan Huang
,
Anthony Lin Zhang
,
Charlie Changli Xue
,
Xusheng Liu
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3389/fendo.2024.1334609
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.3389/fendo.2024.1334609
Background Diabetic kidney disease (DKD) has become the leading cause of kidney failure, causing a significant socioeconomic burden worldwide. The usual care for DKD fails to achieve satisfactory effects in delaying the persistent loss of renal function. A Chinese herbal medicine, Tangshen Qushi Formula (TQF), showed preliminary clinical benefits with a sound safety profile for people with stage 2-4 DKD. We present the protocol of an ongoing clinical trial investigating the feasibility, efficacy, and safety of TQF compared to placebo in delaying the progressive decline of renal function for people with stage 2-4 DKD. Methods A mixed methods research design will be used in this study. A randomized, double-blind, placebo-controlled pilot trial will evaluate the feasibility, efficacy, and safety of TQF compared to placebo on kidney function for people with stage 2-4 DKD. An embedded semi-structured interview will explore the acceptability of TQF granules and trial procedures from the participant’s perspective. Sixty eligible participants with stage 2-4 DKD will be randomly allocated to the treatment group (TQF plus usual care) or the control group (TQF placebo plus usual care) at a 1:1 ratio for 48-week treatment and 12-week follow-up. Participants will be assessed every 12 weeks. The feasibility will be assessed as the primary outcome. The changes in the estimated glomerular filtration rate, urinary protein/albumin, renal function, glycemic and lipid markers, renal composite endpoint events, and dampness syndrome of Chinese medicine will be assessed as the efficacy outcomes. Safety outcomes such as liver function, serum potassium, and adverse events will also be evaluated. The data and safety monitoring board will be responsible for the participants’ benefits, the data’s credibility, and the results’ validity. The intent-to-treat and per-protocol analysis will be performed as the primary statistical strategy. Discussion Conducting a rigorously designed pilot trial will be a significant step toward establishing the feasibility and acceptability of TQF and trial design. The study will also provide critical information for future full-scale trial design to further generate new evidence supporting clinical practice for people with stage 2-4 DKD. Trial registration number https://www.chictr.org.cn/ , identifier ChiCTR2200062786.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3389/fendo.2024.1334609
- https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1334609/pdf
- OA Status
- gold
- Cited By
- 2
- References
- 51
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4391649723
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4391649723Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3389/fendo.2024.1334609Digital Object Identifier
- Title
-
Oral Chinese Herbal Medicine plus usual care for diabetic kidney disease: study protocol for a randomized, double-blind, placebo-controlled pilot trialWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-02-08Full publication date if available
- Authors
-
Meifang Liu, Yuan Ming Di, Lei Zhang, Lihong Yang, Zhang La, Junhui Chen, Ruobing Wang, Xiaoning Xie, Fang Lan, Liping Xie, Juan Huang, Anthony Lin Zhang, Charlie Changli Xue, Xusheng LiuList of authors in order
- Landing page
-
https://doi.org/10.3389/fendo.2024.1334609Publisher landing page
- PDF URL
-
https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1334609/pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1334609/pdfDirect OA link when available
- Concepts
-
Medicine, Placebo, Randomized controlled trial, Renal function, Clinical trial, Clinical endpoint, Kidney disease, Internal medicine, Traditional Chinese medicine, Physical therapy, Alternative medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
2Total citation count in OpenAlex
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2025: 1, 2024: 1Per-year citation counts (last 5 years)
- References (count)
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51Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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