Diabetes Mellitus, Type 2NCT06778018
Nutritional Outcomes of Lotus Seed (Nelumbo Nucifera) on Diabetic Sensorimotor Polyneuropathy
A study testing Lotus Seed in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathies, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
- What is being tested?
- Lotus Seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2024to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a clinical diagnosis of cardiovascular conditions.
- Cancer patients will be excluded from the study.
- Individuals diagnosed with rheumatoid arthritis.
- Individuals with a urinary tract infection.
- Individuals diagnosed with psychological disorders.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Lotus Seed (Nelumbo Nucifera) on the Nutritional, Electrophysiological and Immunomodulatory Outcomes in Patients With Diabetic Sensorimotor Polyneuropathy
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.
Read the detailed description
The research project aims to investigate the therapeutic impact of Lotus Seed (Nelumbo nucifera) on Diabetic Sensorimotor Polyneuropathy (DSPN), a common complication observed in patients with type 1 and type 2 diabetes. DSPN is caused by chronic hyperglycemia, which leads to the degeneration of sensory and motor nerves, particularly the long peripheral nerves that extend to the arms, hands, legs, and feet. This damage results in pain, tingling, numbness, and loss of motor control. Additionally, DSPN can affect the functioning of the digestive system, urinary tract, blood vessels, and cardiovascular system. Over time, it serves as a precursor to more severe complications such as non-healing diabetic wounds, infections, diabetic foot ulcers, amputations, and, in extreme cases, death. The resulting neurological dysfunctions significantly reduce the quality of life for diabetic patients.
Conventional management of DSPN emphasizes glycemic control, symptom relief, and the prevention of long-term complications. Treatment options typically include medications for pain relief, such as neuropathic pain medications, alongside lifestyle changes and regular health monitoring. However, emerging research suggests that functional foods with neuroprotective properties, such as Lotus Seed, may offer an alternative or complementary approach. Histological studies indicate that Lotus exhibits neuroprotective and regenerative effects on nerve cells by inhibiting cellular apoptosis, especially during the acute injury phase. It has also been found to support axonal regeneration, reduce axonal dieback, and enhance motor function recovery. Additionally, Lotus overexpression has been shown to improve neuronal plasticity in the brainstem and cervical spinal cord after stroke, demonstrating its potential for future therapeutic applications in nerve-related disorders.
This study will be a 9-month randomized controlled trial (RCT) conducted at a private hospital in Lahore, Pakistan, targeting patients with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). The participants will be randomly assigned to one of two groups. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsule, while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg. The intervention period will last for 3 months, followed by two post-intervention follow-ups at 6 and 9 months to monitor the sustainability of the treatment effects. Before enrollment, all participants will provide informed consent, and their baseline health status will be assessed through comprehensive testing.
The key parameters to be evaluated include both nutritional, biochemical, and electrophysiological markers. Nutritional impact will be measured through anthropometric indices (such as Body Mass Index), dietary intake assessments, and changes in overall nutritional status. Serum biochemical tests will analyze metabolic markers, including glycemic parameters (HbA1c), lipid profile, liver function, and renal function. Neurological assessments will include the Neuropathy Disability Score and an evaluation of immune-modulatory responses to track changes in nerve function. These tests will be conducted at four time points: baseline (pre-intervention), 3 months (end of intervention), 6 months (follow-up), and 9 months (final follow-up).
All collected data will be analyzed using SPSS version 25. Statistical analysis will focus on comparing changes in health outcomes between the control and treatment groups to determine the impact of Lotus Seed supplementation on DSPN management. This research aims to establish evidence for the use of Lotus Seed as a functional food that can complement standard medical treatment, promoting nerve regeneration, improving metabolic parameters, and enhancing the overall health and well-being of patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
- Being tested
- Lotus Seed, Placebo
- Keywords
- Diabetic Sensorimotor Polyneuropathy, Lotus Seed, Electrophysiological, Neuroprotective, Type 2 Diabetes, Nutritional
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotus SeedDietary supplement
Regimen supplemented with 200 mg/kg of Lotus Seed capsules for 9-month randomized controlled trial.
PlaceboDietary supplement
Regimen supplemented with 200 mg/kg of Starch capsules for 9-month randomized controlled trial.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control group) | Placebo comparator | 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 3 months (end of intervention), 6 months, and 9 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, enabling comparisons of pre- and post-intervention outcomes between the two groups. Receives: Dietary Supplement: Placebo |
| Group B (Treatment group) | Experimental | 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 3 months (end of intervention), 6 months, and 9 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, enabling comparisons of pre- and post-intervention outcomes between the two groups. Receives: Dietary Supplement: Lotus Seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
The Body Mass Index (BMI) will be calculated based on an individual's height and weight. Height will be measured using a stadiometer, and weight will be assessed with a weighing scale. BMI will be derived by dividing the weight in kilograms by the square of the height in meters. The classification thresholds established by the World Health Organization (WHO) will be utilized for interpretation.
Measured: 9 months
HbA1c
The HbA1c level of 6.5% will be measured by drawing blood from the individuals, followed by analysis to detect the presence of diabetes.
Measured: 9 months
Lipid Profile
A blood lipid profile will be collected from the individuals, and the analysis will be performed at the Private Hospital. The lipid profile will assess total cholesterol, very low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride levels.
Measured: 9 months
Alanine Transaminase (ALT)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alanine transaminase (ALT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-aspartate transaminase (AST)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure aspartate transaminase (AST). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-alkaline phosphatase (ALP)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alkaline phosphatase (ALP). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-gamma-glutamyl transferase (GGT)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure gamma-glutamyl transferase (GGT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-serum bilirubin
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure serum bilirubin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-prothrombin time (PT)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure prothrombin time (PT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-international normalized ratio (INR)
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure international normalized ratio (INR). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-total protein
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure total protein. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Liver Function Test-albumin
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure albumin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Measured: 9 months
Renal Function Test-serum creatinine
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like serum creatinine. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Measured: 9 months
Renal Function Test-blood urea nitrogen (BUN)
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like blood urea nitrogen (BUN). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Measured: 9 months
Renal Function Test- glomerular filtration rate (GFR)
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like glomerular filtration rate (GFR). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Measured: 9 months
Renal Function Test-electrolytes such as sodium, potassium, and chloride
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like electrolytes such as sodium, potassium, and chloride. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Measured: 9 months
Neuropathy disability score (NDS)
The Neuropathy Disability Score (NDS) is a widely used clinical tool to evaluate signs of neuropathy. This assessment focuses on four key signs of neuropathy: ankle reflex, vibration sensation, pinprick sensation, and temperature perception, all tested on both sides of the largest toes. The total possible score is 10, with scores above 6 typically indicating an abnormal result.
Measured: 9 months
Cell mediated Response CD4, CD3 and CD8.
The patient's immune response will be assessed by measuring CD4, CD3, and CD8 levels at the Private Hospital. CD4 cells are the predominant T cells in healthy individuals and play a crucial role in assisting B cells with antibody production and enhancing immune reactions to antigens. CD4 cell count is often used as an indicator of immune suppression, with lower levels suggesting a gradual decline in immune function.
Measured: 9 months
Interleukin-6 (IL-6)
IL-6 is a cytokine, which is a type of protein produced by the immune system to regulate inflammation and immune responses. It is secreted by various cells, including macrophages, T lymphocytes, adipocytes, and endothelial cells, particularly in response to infection, tissue injury, or metabolic stress. Measurement of IL-6 levels can help determine the presence and extent of systemic inflammation, as elevated levels are commonly associated with chronic inflammatory conditions. In the context of diabetes, IL-6 plays a significant role in the development of insulin resistance and metabolic dysregulation. Increased IL-6 levels are often observed in individuals with poor glycemic control and may contribute to the progression of diabetes-related complications. Therefore, assessment of IL-6 provides valuable insight into the patient's inflammatory profile and overall disease status.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start10 Dec 2024
- Primary completion10 Feb 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 40 and above age will be formed in which participants will be randomly divided. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsules (Starch) at the dose rate of 200mg/kg. , while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moha Akram Khan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778018
- Sponsor's protocol ID
- REC/RCR&AHS/24/1301
- Status last verified
- May 2026
- First submitted
- 20 Dec 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu J, Hu Z, Luo Y, Liu Y, Luo W, Du X, Luo Z, Hu J, Peng S. Diabetic peripheral neuropathy: pathogenetic mechanisms and treatment. Front Endocrinol (Lausanne). 2024 Jan 9;14:1265372. doi: 10.3389/fendo.2023.1265372. eCollection 2023.
PubMed 38264279
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lotus Seed (Nelumbo Nucifera) on the Nutritional, Electrophysiological and Immunomodulatory Outcomes in Patients With Diabetic Sensorimotor Polyneuropathy
- ClinicalTrials.gov ID
- NCT06778018
- Acronym / sponsor ID
- REC/RCR&AHS/24/1301
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
- Keywords
- Diabetic Sensorimotor Polyneuropathy, Lotus Seed, Electrophysiological, Neuroprotective, Type 2 Diabetes, Nutritional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research project aims to investigate the therapeutic impact of Lotus Seed (Nelumbo nucifera) on Diabetic Sensorimotor Polyneuropathy (DSPN), a common complication observed in patients with type 1 and type 2 diabetes. DSPN is caused by chronic hyperglycemia, which leads to the degeneration of sensory and motor nerves, particularly the long peripheral nerves that extend to the arms, hands, legs, and feet. This damage results in pain, tingling, numbness, and loss of motor control. Additionally, DSPN can affect the functioning of the digestive system, urinary tract, blood vessels, and cardiovascular system. Over time, it serves as a precursor to more severe complications such as non-healing diabetic wounds, infections, diabetic foot ulcers, amputations, and, in extreme cases, death. The resulting neurological dysfunctions significantly reduce the quality of life for diabetic patients.
Conventional management of DSPN emphasizes glycemic control, symptom relief, and the prevention of long-term complications. Treatment options typically include medications for pain relief, such as neuropathic pain medications, alongside lifestyle changes and regular health monitoring. However, emerging research suggests that functional foods with neuroprotective properties, such as Lotus Seed, may offer an alternative or complementary approach. Histological studies indicate that Lotus exhibits neuroprotective and regenerative effects on nerve cells by inhibiting cellular apoptosis, especially during the acute injury phase. It has also been found to support axonal regeneration, reduce axonal dieback, and enhance motor function recovery. Additionally, Lotus overexpression has been shown to improve neuronal plasticity in the brainstem and cervical spinal cord after stroke, demonstrating its potential for future therapeutic applications in nerve-related disorders.
This study will be a 9-month randomized controlled trial (RCT) conducted at a private hospital in Lahore, Pakistan, targeting patients with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). The participants will be randomly assigned to one of two groups. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsule, while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg. The intervention period will last for 3 months, followed by two post-intervention follow-ups at 6 and 9 months to monitor the sustainability of the treatment effects. Before enrollment, all participants will provide informed consent, and their baseline health status will be assessed through comprehensive testing.
The key parameters to be evaluated include both nutritional, biochemical, and electrophysiological markers. Nutritional impact will be measured through anthropometric indices (such as Body Mass Index), dietary intake assessments, and changes in overall nutritional status. Serum biochemical tests will analyze metabolic markers, including glycemic parameters (HbA1c), lipid profile, liver function, and renal function. Neurological assessments will include the Neuropathy Disability Score and an evaluation of immune-modulatory responses to track changes in nerve function. These tests will be conducted at four time points: baseline (pre-intervention), 3 months (end of intervention), 6 months (follow-up), and 9 months (final follow-up).
All collected data will be analyzed using SPSS version 25. Statistical analysis will focus on comparing changes in health outcomes between the control and treatment groups to determine the impact of Lotus Seed supplementation on DSPN management. This research aims to establish evidence for the use of Lotus Seed as a functional food that can complement standard medical treatment, promoting nerve regeneration, improving metabolic parameters, and enhancing the overall health and well-being of patients with type 2 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 40 and above age will be formed in which participants will be randomly divided. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsules (Starch) at the dose rate of 200mg/kg. , while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg.
| Arm | Type | Receives |
|---|---|---|
| Group A (Control group) | Placebo comparator | Dietary Supplement: PlaceboThis group will receive the placebo treatment (starch) 200 mg/kg capsules. Baseline assessments will be conducted before the intervention, followed by health evaluations at 3 months (end of intervention), 6 months, and 9 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, enabling comparisons of pre- and post-intervention outcomes between the two groups. |
| Group B (Treatment group) | Experimental | Dietary Supplement: Lotus SeedThis 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 3 months (end of intervention), 6 months, and 9 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, enabling comparisons of pre- and post-intervention outcomes between the two groups. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Individuals with a clinical diagnosis of cardiovascular conditions.
- Cancer patients will be excluded from the study.
- Individuals diagnosed with rheumatoid arthritis.
- Individuals with a urinary tract infection.
- Individuals diagnosed with psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotus SeedRegimen supplemented with 200 mg/kg of Lotus Seed capsules for 9-month randomized controlled trial. | Dietary supplement | Group B (Treatment group) |
| PlaceboRegimen supplemented with 200 mg/kg of Starch capsules for 9-month randomized controlled trial. | Dietary supplement | Group A (Control group) |
Primary outcome
Body Mass Index (BMI)
Time frame: 9 months
The Body Mass Index (BMI) will be calculated based on an individual's height and weight. Height will be measured using a stadiometer, and weight will be assessed with a weighing scale. BMI will be derived by dividing the weight in kilograms by the square of the height in meters. The classification thresholds established by the World Health Organization (WHO) will be utilized for interpretation.
HbA1c
Time frame: 9 months
The HbA1c level of 6.5% will be measured by drawing blood from the individuals, followed by analysis to detect the presence of diabetes.
Lipid Profile
Time frame: 9 months
A blood lipid profile will be collected from the individuals, and the analysis will be performed at the Private Hospital. The lipid profile will assess total cholesterol, very low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride levels.
Alanine Transaminase (ALT)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alanine transaminase (ALT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-aspartate transaminase (AST)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure aspartate transaminase (AST). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-alkaline phosphatase (ALP)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alkaline phosphatase (ALP). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-gamma-glutamyl transferase (GGT)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure gamma-glutamyl transferase (GGT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-serum bilirubin
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure serum bilirubin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-prothrombin time (PT)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure prothrombin time (PT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-international normalized ratio (INR)
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure international normalized ratio (INR). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-total protein
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure total protein. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Liver Function Test-albumin
Time frame: 9 months
Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure albumin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.
Renal Function Test-serum creatinine
Time frame: 9 months
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like serum creatinine. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Renal Function Test-blood urea nitrogen (BUN)
Time frame: 9 months
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like blood urea nitrogen (BUN). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Renal Function Test- glomerular filtration rate (GFR)
Time frame: 9 months
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like glomerular filtration rate (GFR). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Renal Function Test-electrolytes such as sodium, potassium, and chloride
Time frame: 9 months
Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like electrolytes such as sodium, potassium, and chloride. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.
Neuropathy disability score (NDS)
Time frame: 9 months
The Neuropathy Disability Score (NDS) is a widely used clinical tool to evaluate signs of neuropathy. This assessment focuses on four key signs of neuropathy: ankle reflex, vibration sensation, pinprick sensation, and temperature perception, all tested on both sides of the largest toes. The total possible score is 10, with scores above 6 typically indicating an abnormal result.
Cell mediated Response CD4, CD3 and CD8.
Time frame: 9 months
The patient's immune response will be assessed by measuring CD4, CD3, and CD8 levels at the Private Hospital. CD4 cells are the predominant T cells in healthy individuals and play a crucial role in assisting B cells with antibody production and enhancing immune reactions to antigens. CD4 cell count is often used as an indicator of immune suppression, with lower levels suggesting a gradual decline in immune function.
Interleukin-6 (IL-6)
Time frame: 9 months
IL-6 is a cytokine, which is a type of protein produced by the immune system to regulate inflammation and immune responses. It is secreted by various cells, including macrophages, T lymphocytes, adipocytes, and endothelial cells, particularly in response to infection, tissue injury, or metabolic stress. Measurement of IL-6 levels can help determine the presence and extent of systemic inflammation, as elevated levels are commonly associated with chronic inflammatory conditions. In the context of diabetes, IL-6 plays a significant role in the development of insulin resistance and metabolic dysregulation. Increased IL-6 levels are often observed in individuals with poor glycemic control and may contribute to the progression of diabetes-related complications. Therefore, assessment of IL-6 provides valuable insight into the patient's inflammatory profile and overall disease status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 38264279Zhu J, Hu Z, Luo Y, Liu Y, Luo W, Du X, Luo Z, Hu J, Peng S. Diabetic peripheral neuropathy: pathogenetic mechanisms and treatment. Front Endocrinol (Lausanne). 2024 Jan 9;14:1265372. doi: 10.3389/fendo.2023.1265372. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moha Akram Khan, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotus Seed in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathies, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: 9 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06778018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.