ArticleTrials2019
Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III-IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.
- Interventions for preventing the progression of autosomal dominant polycystic kidney disease.The Cochrane database of systematic reviews · 2024Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundAutosomal dominant polycystic kidney disease (ADPKD) is one of the most common potentially life-threatening inherited kidney diseases. It is the fourth most common cause of end-stage renal disease requiring renal replacement therapy. There are few management options for controlling disease progression. Hence, identification of alternative treatments for patients is important. The Chinese herbal yinang formulation (YNF), which is derived from a Chinese patent medicine, appears to have a satisfactory effect in treating ADPKD. Because a considerable proportion of ADPKD patients presenting with chronic kidney disease (CKD) stages III-IV are diagnosed with the spleen, kidney deficiency, and blood stasis syndrome according to the diagnostic criteria of traditional Chinese medicine (TCM), we hypothesize that YNF may be a complementary drug for ADPKD patients with the corresponding syndrome. Therefore, we have designed a strict clinical trial to evaluate the safety and efficacy of YNF for ADPKD patients with CKD stages III-IV exhibiting the TCM syndrome of spleen, kidney deficiency, and blood stasis. METHODS/
designThis is a multi-center prospective double-blind randomized controlled trial. The total target sample size is planned to be 72 participants, with a balanced treatment allocation (1:1). The experimental intervention will be YNF plus conventional therapy and the control intervention will be a placebo plus conventional therapy for 24 weeks. An additional 24 weeks of follow-up will be conducted after treatment completion. The primary outcome will be the estimated glomerular filtration rate (eGFR). Changes in total kidney volume (TKV), serum creatinine (Scr), blood urea nitrogen (BUN), TCM symptoms, and pain will be the secondary outcomes. Adverse events (AEs) will be monitored throughout the trial. DISCUSSION: This study will be the first placebo-controlled randomized controlled trial to assess whether YNF plus conventional therapy has a beneficial effect on eGFR, TKV, Scr, and BUN, and whether it can alleviate TCM clinical symptoms, reduce ADPKD-related pain, and reduce the frequency of AEs for ADPKD patients with CKD stages III-IV with the spleen, kidney deficiency, and blood stasis syndrome. The results of this trial may provide an evidence-based recommendation for clinicians.
trial registrationChinese Clinical Trials Register, ChiCTR-INR-16009914 . Registered on 18 November 2016.
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