The study focuses on Diabetic Sensorimotor Polyneuropathy (DSPN), a common complication of type 1 and type 2 diabetes caused by hyperglycemia-induced nerve damage, leading to pain, numbness, and motor dysfunction in the limbs. It also affects the digestive system, urinary tract, and cardiovascular health, often resulting in diabetic foot ulcers, amputations, and reduced quality of life. Current management involves glycemic control, pain relief, and complication prevention. Recent research highlights the neuroprotective potential of Lotus (Nelumbo nucifera) in promoting axonal regeneration, suppressing apoptosis, and enhancing motor function recovery. This randomized controlled trial will investigate the anti-diabetic effects of Lotus Seed in type 2 diabetes patients at a private hospital in Lahore, Pakistan, over 9 months. Participants will be divided into a control group receiving a standard antidiabetic regimen with placebo capsules and a treatment group receiving 200 mg/kg of Lotus Seed capsules alongside the antidiabetic regimen. Baseline characteristics and post-intervention changes will be assessed through nutritional impact (BMI, dietary intake), serum biochemical tests (HbA1c, lipid profile, liver, and renal function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory tests). Data collection will occur at baseline, 3 months (end of intervention), and follow-ups at 6 and 9 months. SPSS version 25 will be used for statistical analysis to evaluate the potential of Lotus Seed as a functional food for managing DSPN and improving health outcomes in diabetic patients.
Age range
40 Years – 60 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Body Mass Index (BMI)
Timeframe: 9 months
HbA1c
Timeframe: 9 months
Lipid Profile
Timeframe: 9 months
Alanine Transaminase (ALT)
Timeframe: 9 months
Liver Function Test-aspartate transaminase (AST)
Timeframe: 9 months
Liver Function Test-alkaline phosphatase (ALP)
Timeframe: 9 months
Liver Function Test-gamma-glutamyl transferase (GGT)
Timeframe: 9 months
Liver Function Test-serum bilirubin
Timeframe: 9 months
Liver Function Test-prothrombin time (PT)
Timeframe: 9 months
Liver Function Test-international normalized ratio (INR)
Timeframe: 9 months
Liver Function Test-total protein
Timeframe: 9 months
Liver Function Test-albumin
Timeframe: 9 months
Renal Function Test-serum creatinine
Timeframe: 9 months
Renal Function Test-blood urea nitrogen (BUN)
Timeframe: 9 months
Renal Function Test- glomerular filtration rate (GFR)
Timeframe: 9 months
Renal Function Test-electrolytes such as sodium, potassium, and chloride
Timeframe: 9 months
Neuropathy disability score (NDS)
Timeframe: 9 months
Cell mediated Response CD4, CD3 and CD8.
Timeframe: 9 months
Interleukin-6 (IL-6)
Timeframe: 9 months