NCT06778018Completed
Nutritional Outcomes of Lotus Seed (Nelumbo Nucifera) on Diabetic Sensorimotor Polyneuropathy
Effects of Lotus Seed (Nelumbo Nucifera) on the Nutritional, Electrophysiological and Immunomodulatory Outcomes in Patients With Diabetic Sensorimotor Polyneuropathy
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 20 Dec 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Riphah International University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06778018
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 10 Dec 2024 to the primary completion date, 10 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Individuals with a clinical diagnosis of cardiovascular conditions.
- Cancer patients will be excluded from the study.
- Individuals with a urinary tract infection.
- Individuals diagnosed with psychological disorders.
Other
- Individuals diagnosed with rheumatoid arthritis.
- Pregnant or breastfeeding women.
Who the study is looking for
- Participants who have been clinically diagnosed with T2DM (Type 2 Diabetes Mellitus).
- Participants who have been clinically diagnosed with neuropathy symptoms for at least 1 year.
- Both male and female participants.
- Participants aged 40 years and older.
- Participants capable of understanding basic instructions, either independently or with assistance from their family.
Age in the registry: 40 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Riphah International University Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.