Effects of Lotus Seed (Nelumbo Nucifera) on the Nutritional, Electrophysiological and Immunomodulatory Outcomes in Patients With Diabetic Sensorimotor Polyneuropathy

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 12 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, 6 months (end of intervention), and follow-ups at 9 and 12 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Riphah international university
RECRUITING
Lahore
Contact Information
Primary
: Imran Amjad, PhD
imran.amjad@riphah.edu.pk
+92 33224390125
Backup
Muhammad Imran Hussain, PhD
Imran.hussain@riphah.edu.pk
+92 300 4478597
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Group A (Control group)
This group will receive the placebo treatment (starch) 200 mg/kg capsules. Baseline assessments will be conducted before the intervention, followed by health evaluations at 6 months (end of intervention), 9 months, and 12 months (follow-up assessments). Comprehensive health assessments will include nutritional status (BMI, dietary intake), biochemical markers (HbA1c, lipid profile, liver, and kidney function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory response). The data collected will be analyzed using SPSS version 25, allowing for comparisons between pre- and post-intervention outcomes in both groups.
Experimental: Group B (Treatment group)
This group will receive the intervention treatment 200 mg/kg Lotus Seed capsules. Baseline assessments will be conducted before the intervention, followed by health evaluations at 6 months (end of intervention), 9 months, and 12 months (follow-up assessments). Comprehensive health assessments will include nutritional status (BMI, dietary intake), biochemical markers (HbA1c, lipid profile, liver, and kidney function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory response). The data collected will be analyzed using SPSS version 25, allowing for comparisons between pre- and post-intervention outcomes in both groups.
Sponsors
Leads: Riphah International University

This content was sourced from clinicaltrials.gov