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Efficacy and safety of Plantago major seeds in patients with diabetic nephropathy: A randomized open-labeled controlled clinical trial.

  • 2024-11
  • Explore (New York, N.Y.) 20(6)
    • Romella Haider
    • Majid Asghari
    • Fatemeh Aliasl
    • Mohammad Aghaali
    • Razieh Borujerdi
    • Hossein Saghafi
    • Hossein Moradi

Study Design

Type
Randomized Controlled Trial (RCT)
Population
60 DN patients
Methods
randomized clinical trial; plantain group received standard treatment (Losartan 25 mg twice a day) and plantain seeds' powder (10 gm sachet twice a day) plus sweet almond; control group received only standard treatment for 60 days
Blinding
Open-label
Duration
60 days
Funding
Unclear

Background

Diabetic Nephropathy (DN) is characterized by albuminuria and a declining glomerular filtration rate (GFR) in diabetic patients. Plantago major (plantain) seed powder is traditionally used in these patients. Despite emerging and promising pre-clinical evidence, no clinical study investigated the potential efficacy of this intervention in patients with DN, which is the aim of this study.

Methods

In a randomized clinical trial 60 DN patients were recruited from November 2022 to March 2023 and randomly assigned to the plantain group that received standard treatment (Losartan 25 mg twice a day) and plantain seeds' powder (10 gm sachet twice a day) plus sweet almond and the control group was received only standard treatment for 60 days. Proteinuria, as per 24-hour urinary protein, as well as fasting blood sugar (FBS), blood urea nitrogen (BUN), serum creatinine, serum potassium, and quality of life score were measured at baseline and after 60 days as study outcome measures.

Results

Proteinuria was significantly decreased from 165.04 mg to 135.84 mg (p = 0.026) in the plantain group. The mean level of proteinuria was significantly lower in the plantain group (135.84 vs. 192.04, p = 0.039) compared to the control group after treatment. The plantain group showed more increase in quality of life score after treatment (33.89±9.67 vs 38.28±10.72, p = 0.041). Other outcomes showed no significant difference between the two study groups.

Conclusion

Adjuvant supplementation with plantain seeds powder may decrease proteinuria in patients with diabetic nephropathy. Further studies with larger sample sizes and longer duration are needed to confirm these results.

Research Insights

  • Almond→Improved Quality of Life

    The plantain group showed more increase in quality of life score after treatment (33.89±9.67 vs 38.28±10.72, p = 0.041).

    Effect
    Beneficial
    Effect size
    Small
  • Almond→Reduced Proteinuria

    Proteinuria was significantly decreased from 165.04 mg to 135.84 mg (p = 0.026) in the plantain group.

    Effect
    Beneficial
    Effect size
    Small
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