Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568185
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Fixed Dose Combination of Alpha Lipoic Acid and Vitamin B Preparations for Treatment of Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patients A Randomized Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of combination of vitamin B and alpha lipoic acid formulations for the treatment of diabetic polyneuropathy in individuals with type 2 diabetes mellitus
Methodology
This is a single-center randomized double-blind placebo-controlled trial study
Study duration May 2024 - September 2025
Study location
This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia
Source Reference
People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia
Study source population
People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period
Methodology
This is a single-center randomized double-blind placebo-controlled trial study
Study duration May 2024 - September 2025
Study location
This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia
Source Reference
People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia
Study source population
People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period
Detailed Description:
General objective
To determine the effectiveness of a fixed dose combination of alpha lipoic acid and vitamin B preparations in comparison with incative drug for treatment of diabetic polyneuropathy DPN in people with type 2 diabetes mellitus
Research hypothesis
1 There are significant improvements in mean total symptom score TSS and neuropathic symptoms score NSS in people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic polyneuropathy patients taking a placebo
2 There are significant improvements in total symptom score TSS and neuropathic symptoms score NSS among people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks
3 There are significant improvements in fasting plasma glucose HbA1C level fasting lipid profile body mass index BMI and diabetes quality of life in people with diabetes taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic patients taking placebo
4 There are no significant differences in the safety parameters of renal function and liver function tests among people with diabetic polyneuropathy at baseline and 12 weeks after taking a fixed dose combination of alpha lipoic acid and vitamin B preparations
5 There are significant improvements in fasting plasma glucose HbA1C level fasting lipid profile body mass index BMI and diabetes quality of life among diabetic patients taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks
Method of data collection
This study will be conducted after obtaining approval from the Universiti Sains Malaysia Ethical Committee JPeM and will be conducted in accordance to World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects
Recruitment of subject
Participants will be recruited from Klinik Rawatan Keluarga and diabetes clinic Hospital USM via convenience sampling Potential participants will be identified from the case notes of patients Then the participants will be approached individually Those who are willing to participate in this study will be given information regarding the study The participants will be screened to determine their eligibility criteria including performing neurological symptom score NSS and neuropathy disability score NDS to determine diabetes polyneuropathy diagnosis If all the inclusion and exclusion criteria are fulfilled informed consent will be obtained from all patients who agree to participate in this study The consent will be obtained by a study team that recruited the patient Upon consented the participants socio-demographic data will be collected and the medical record will be assessed to fill in their medical and diabetes profiles They will also answer the total symptoms score TSS and revised version of the Diabetes Quality of Life Rv-DQoL questionnaire The physical examination includes measurement of height weight calculated Body Mass Index BMI and blood pressure during sitting will be done Then 6ml of fasting venous blood will be taken for measurement of HbA1c fasting blood glucose renal function test liver function test and fasting lipid profile as baseline All participants were advised not to consume any special supplement or other replacement meal throughout the study
The participants then will be randomized to either intervention or control group The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations and the control group will receive a placebo look-alike substance that contains no drug
The participants will be seen 6 weeks after taking the product During this visit they will be assessed for any side effects or adverse events and compliance with the product supplied compliance form The total symptoms score TSS neurological symptom score NSS a revised version of Diabetes Quality of Life Rv-DQoL blood pressure weight height calculated Body Mass Index BMI will also be measured Another 6-week supply of the product will be given
Lastly the participants will be assessed in week 12 During this visit the same measurement will be taken as visit 1 including answering the questionnaires Adverse events blood taking and compliance will also be assessed
The duration for visit 1 and visit 3 at 12 weeks is about 50-60 minutes for each visit since it will involve blood taking procedure Duration for visit 2 at 6 weeks is about 30 minutes since it will not involve blood taking
Intervention group Fixed dose combination of alpha lipoic acid and vitamin B preparations
At baseline the intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations This product is packaged and manufactured by BREGO Life Sciences Sdn Bhd company with a brand name of Bionerv BIONERV is the first combination of alpha lipoic acid 300mg and vitamin B complex Bionerv is in oral film-coated orange colour oblong shape and no marking and embossing on the tablet Each tablet contains 4 active ingredients as follows Alpha lipoic acid 300mg Vitamin B12 methylcobalamin 500mcg Vitamin B6 pyridoxine 8mg Vitamin B1 thiamine 39mg All the above ingredients are synthetic The shelf-life is 2 years Storage condition is keeping in dry place below 300oC and protecting from light and moisture It has no bovine-gelatin capsule There are no precautions on drug-drug interaction but it is not suitable for children 18 years There is insufficient reliable data for pregnancy and breast feeding One bottle consists of 60 tablets
This medication needs to take 2 tablets a day after a meal and need to drink more water In this study the participants need to take 2 tablets once daily after breakfast The duration of the intervention will be 12 weeks All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment
Control group
At baseline the control group will receive a placebo drug consisting of Croscamellose Sodium Microcrystalline Cellulose Silicon Dioxide and Magnesium stearate The placebo was manufactured by Yanling Natural Hygiene Sdn Bhd The formulation of the placebo tablet is derived from the excipients used in the Bionerv tablet
The participants need to take 2 tablets once daily after breakfast The placebo drugs will share the same appearance and color as intervention drug
The duration of the intervention will be 12 weeks All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment
Follow up
There are two follow-ups during this study 1st follow-up will be on the 6th week and 2nd follow-up final follow-up will be during 12th week of the study
During the 6th week follow-up participants will be checked for their weight height calculated Body Mass Index BMI TSS NSS RV-DQoL questionnaire compliance and adverse effects
A final visit 12th week to the clinic will be conducted on the 12th week During these visits the outcome measures will be assessed to determine the effect of the fixed-dose combination of alpha lipoic acid and vitamin B During this visit the same measurement will be taken as visit 1
To determine the effectiveness of a fixed dose combination of alpha lipoic acid and vitamin B preparations in comparison with incative drug for treatment of diabetic polyneuropathy DPN in people with type 2 diabetes mellitus
Research hypothesis
1 There are significant improvements in mean total symptom score TSS and neuropathic symptoms score NSS in people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic polyneuropathy patients taking a placebo
2 There are significant improvements in total symptom score TSS and neuropathic symptoms score NSS among people with diabetic polyneuropathy taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks
3 There are significant improvements in fasting plasma glucose HbA1C level fasting lipid profile body mass index BMI and diabetes quality of life in people with diabetes taking a fixed dose combination of alpha lipoic acid and vitamin B preparations as compared to diabetic patients taking placebo
4 There are no significant differences in the safety parameters of renal function and liver function tests among people with diabetic polyneuropathy at baseline and 12 weeks after taking a fixed dose combination of alpha lipoic acid and vitamin B preparations
5 There are significant improvements in fasting plasma glucose HbA1C level fasting lipid profile body mass index BMI and diabetes quality of life among diabetic patients taking a fixed dose combination of alpha lipoic acid and vitamin B preparations for 12 weeks
Method of data collection
This study will be conducted after obtaining approval from the Universiti Sains Malaysia Ethical Committee JPeM and will be conducted in accordance to World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects
Recruitment of subject
Participants will be recruited from Klinik Rawatan Keluarga and diabetes clinic Hospital USM via convenience sampling Potential participants will be identified from the case notes of patients Then the participants will be approached individually Those who are willing to participate in this study will be given information regarding the study The participants will be screened to determine their eligibility criteria including performing neurological symptom score NSS and neuropathy disability score NDS to determine diabetes polyneuropathy diagnosis If all the inclusion and exclusion criteria are fulfilled informed consent will be obtained from all patients who agree to participate in this study The consent will be obtained by a study team that recruited the patient Upon consented the participants socio-demographic data will be collected and the medical record will be assessed to fill in their medical and diabetes profiles They will also answer the total symptoms score TSS and revised version of the Diabetes Quality of Life Rv-DQoL questionnaire The physical examination includes measurement of height weight calculated Body Mass Index BMI and blood pressure during sitting will be done Then 6ml of fasting venous blood will be taken for measurement of HbA1c fasting blood glucose renal function test liver function test and fasting lipid profile as baseline All participants were advised not to consume any special supplement or other replacement meal throughout the study
The participants then will be randomized to either intervention or control group The intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations and the control group will receive a placebo look-alike substance that contains no drug
The participants will be seen 6 weeks after taking the product During this visit they will be assessed for any side effects or adverse events and compliance with the product supplied compliance form The total symptoms score TSS neurological symptom score NSS a revised version of Diabetes Quality of Life Rv-DQoL blood pressure weight height calculated Body Mass Index BMI will also be measured Another 6-week supply of the product will be given
Lastly the participants will be assessed in week 12 During this visit the same measurement will be taken as visit 1 including answering the questionnaires Adverse events blood taking and compliance will also be assessed
The duration for visit 1 and visit 3 at 12 weeks is about 50-60 minutes for each visit since it will involve blood taking procedure Duration for visit 2 at 6 weeks is about 30 minutes since it will not involve blood taking
Intervention group Fixed dose combination of alpha lipoic acid and vitamin B preparations
At baseline the intervention group will receive a fixed dose combination of alpha lipoic acid and vitamin B preparations This product is packaged and manufactured by BREGO Life Sciences Sdn Bhd company with a brand name of Bionerv BIONERV is the first combination of alpha lipoic acid 300mg and vitamin B complex Bionerv is in oral film-coated orange colour oblong shape and no marking and embossing on the tablet Each tablet contains 4 active ingredients as follows Alpha lipoic acid 300mg Vitamin B12 methylcobalamin 500mcg Vitamin B6 pyridoxine 8mg Vitamin B1 thiamine 39mg All the above ingredients are synthetic The shelf-life is 2 years Storage condition is keeping in dry place below 300oC and protecting from light and moisture It has no bovine-gelatin capsule There are no precautions on drug-drug interaction but it is not suitable for children 18 years There is insufficient reliable data for pregnancy and breast feeding One bottle consists of 60 tablets
This medication needs to take 2 tablets a day after a meal and need to drink more water In this study the participants need to take 2 tablets once daily after breakfast The duration of the intervention will be 12 weeks All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment
Control group
At baseline the control group will receive a placebo drug consisting of Croscamellose Sodium Microcrystalline Cellulose Silicon Dioxide and Magnesium stearate The placebo was manufactured by Yanling Natural Hygiene Sdn Bhd The formulation of the placebo tablet is derived from the excipients used in the Bionerv tablet
The participants need to take 2 tablets once daily after breakfast The placebo drugs will share the same appearance and color as intervention drug
The duration of the intervention will be 12 weeks All participants are required to return to the clinic in the 6th and 12th week for a post-intervention assessment
Follow up
There are two follow-ups during this study 1st follow-up will be on the 6th week and 2nd follow-up final follow-up will be during 12th week of the study
During the 6th week follow-up participants will be checked for their weight height calculated Body Mass Index BMI TSS NSS RV-DQoL questionnaire compliance and adverse effects
A final visit 12th week to the clinic will be conducted on the 12th week During these visits the outcome measures will be assessed to determine the effect of the fixed-dose combination of alpha lipoic acid and vitamin B During this visit the same measurement will be taken as visit 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None