Clinical efficacy and safety of okra (Abelmoschus esculentus (L.) Moench) in type 2 diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial.

AIMS: The recent trend toward the use of natural functional and medical supplements has motivated the focus on the search and revival of traditional medicinal plant applications for many years. As a valuable dietary crop, okra fruit (Abelmoschus esculentus (L.) Moench) has been used for thousands of years as a medicinal food. This clinical trial aimed to assess the efficacy and safety of the okra pod capsule as an adjuvant treatment in controlling type 2 diabetes mellitus and provide clinical trial-based evidence about its anti-inflammatory effects. METHODS: A total of 100 type II diabetic patients, aged between 40 and 60 years, were randomly assigned into two groups of okra and placebo. The first group was administered 1000 mg of powdered okra fruit three times a day for 3 months, while the other group received a placebo capsule with the same dosage. Both groups continued the standard antidiabetic therapy (consisting of metformin and gliclazide, as well as a nutritional regimen). At the start and three months later, various factors were measured, including FBG, insulin, HbA1c, cholesterol, triglycerides, HDL, LDL, CRP, liver and renal function tests, blood pressure, and BMI changes. RESULTS: According to the results, patients who received okra treatment exhibited a significant decrease in FBG, HbA1c, total cholesterol, and triglyceride levels when compared to both the baseline and the placebo group. Patients in the okra group have lower levels of hs-CRP compared with the placebo group after 3 months of treatment. No liver, kidney, and blood pressure or other side effects were observed in the groups associated with okra treatment. CONCLUSIONS: The present study demonstrated that adjunctive consumption of okra, in type 2 diabetic patients with 1000 mg three times a day for three months, improves lipid profile, glycemic control, and chronic inflammation without any tangible adverse effects. CLINICAL TRIAL REGISTRY: IRCT.Ir (IRCT20120112008712N2). https://www.irct.ir/trial/42042 .

Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial.

BACKGROUND: IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN. METHODS: We will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks. DISCUSSION: This study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02231125 . Registered on 30 August 2014.