| CTRI Number |
CTRI/2017/10/010035 [Registered on: 06/10/2017] Trial Registered Prospectively |
| Last Modified On: |
24/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate cholesterol lowering effect of Vitamin C as an add on therapy in diabetic patients |
|
Scientific Title of Study
|
Effect of Vitamin C Adjuant Therapy on Lipid Profile in Diabetic Patients with Co-morbid Cardiovascular Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PGeetha |
| Designation |
M.Pharm.,(Ph.D) |
| Affiliation |
Vels University |
| Address |
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University.
Chennai
TAMIL NADU
600117
India |
| Phone |
9940460178 |
| Fax |
|
| Email |
lgeethapharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geetha |
| Designation |
Assistant professor |
| Affiliation |
Vels university |
| Address |
Department of pharmacy practice,
School of pharmaceutical sciences,
Vels university.
Chennai
TAMIL NADU
600117
India |
| Phone |
9940460178 |
| Fax |
|
| Email |
lgeethapharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subalakshmi |
| Designation |
Pharm.D |
| Affiliation |
Vels University |
| Address |
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels University.
Chennai
TAMIL NADU
600117
India |
| Phone |
9094387441 |
| Fax |
|
| Email |
subalakshmi201295@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of pharmaceutical sciences,
Department of pharmacy practice,
Vels university,
Velan nagar,
Pallavaram,
Chennai-117
|
|
|
Primary Sponsor
|
| Name |
School of pharmaceutical sciences |
| Address |
Department of pharmacy practice,
School of pharmaceutical sciences, Vels univesity |
| Type of Sponsor |
Other [Private pharmacy college] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PGeetha |
School of pharmaceutical sciences, Vel University |
Pharmacy practice lab 1,
Department of pharmacy practice,
School of pharmaceutical sciences,
Vels University,
Velan nagar,
Pallavaram,
Chennai-117
Chennai
TAMIL NADU |
9940460178
lgeethapharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, vels university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uncontrolled diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Atorvastatin |
Effect of Vitamin C Adjuant Therapy on Lipid Profile is to be Compared with Atorvastatin |
| Intervention |
Vitamin C |
Evaluation of Effect of Vitamin C Adjuant Therapy in Patients with Diabetes Mellitus |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with type 2 diabetes mellitus for a period of not less than 2 years with co-morbid cardiovascular disease (new onset/past history), whose blood sugar profile is uncontrolled as indicated by HbA1c above 8.0, in treatment with the standard treatment regimen for diabetes mellitus as per the recommended guidelines and willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with concomitant life threatening illness, including myocardial infarction, ischemic stroke or risk of developing NSTEMI, STEMI.
2. Patients with metabolic acidosis
3. Patients who had a history of renal calculi
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of effet of Vitamin C Adjuant therapy significance on lipid profile and HbA1c in diabetes patients with co-morbid cardiovascular disease. |
Baseline, 1st month, 2nd month and 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adjustment for factors those confounds the effect of vitamin therapy on lipid profile and thereby quantify the extent of the effect |
Baseline, 1st month, 2nd month and 3rd month. |
| Evaluation of Incidence of elevated CRP levels in diabetic patients with dislipidemia |
Baseline, 1st month, 2nd month and 3rd month. |
| Assessement of the acute effect of Vitamin C adjuant therapy on serum C-reactive protein. |
Baseline, 1st month, 2nd month and 3rd month. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/10/2017 |
| Date of Study Completion (India) |
14/02/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients with diabetes mellitus have 2 to 4 fold increase in the prevalence of cardiovascular disease compared to non-diabetes mellitus due to rise in blood glucose and serum cholesterol levels. Vitamin C plays important role in prevention of diabetic complications by scavenging free radicals and thus preventing the initiation of chain reactions that leads to protein glycation and protecting against lipid peroxidation. Vitamin C is structurally similar to glucose and can replace it in many chemical reactions and thus is effective for prevention of non-enzymatic glycation of protein. Vitamin C as an antioxidant can probably reduce insulin resistance by improved endothelial function and lowering oxidative stress. |