| CTRI Number |
CTRI/2017/04/008384 [Registered on: 20/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2017 |
| 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 check whether addition of Resveratrol is beneficial and safe in patients with Diabetes, Dyslipidemia and Hypertension (who are already on standard therapy) |
|
Scientific Title of Study
|
A Randomized, Open-Label, Active-Control, Phase-IV clinical study evaluating efficacy and safety of Resveratrol as an adjuvant therapy in patients with Diabetes, Dyslipidemia and Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Mishra |
| Designation |
Consultant Physician |
| Affiliation |
Dept of Medicine, Vikas Hospital, Kalyan West |
| Address |
Vikas Hospital , Opp. Lane no 05, Rambaug, Kalyan (West)
Vikas Hospital , Opp. Lane no 05, Rambaug, Kalyan (West)
Thane
MAHARASHTRA
421301
India |
| Phone |
|
| Fax |
|
| Email |
drhmishra112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Ojha |
| Designation |
PhD scholar |
| Affiliation |
Uka Tarsadia University |
| Address |
Dept of Pharmacology
Uka Tarsadia University
Bardoli,Tarsadi - Surat, Gujarat
Surat
GUJARAT
394350
India |
| Phone |
|
| Fax |
|
| Email |
rakeshojha0712@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Pranesh Kulkarni |
| Designation |
Co-investigator and sub-investigator |
| Affiliation |
Vikas Hospital |
| Address |
Vikas Hospital Kalyan west
Kalyan west
Thane
MAHARASHTRA
421301
India |
| Phone |
|
| Fax |
|
| Email |
dr.praneshck@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Pharmacology, Uka Tarsadia University, Gopal Vidyanagar, Bardoli Mahuva Road,Tarsadi, Bardoli, Pin code: 394350, Surat, gujarat |
|
|
Primary Sponsor
|
| Name |
Rakesh Ojha |
| Address |
Dept of Pharmacology, Uka Tarsadia University, Gopal Vidyanagar, Bardoli Mahuva Road,, Tarsadi, Bardoli, Surat, Pin code: 394350 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Hemant Mishra |
Department of Medicine, Vikas Hospital |
Department of Medicine, Room no 01, Vikas Hospital, Opp. Lane no 05, Rambaug, Kalyan (West)
Thane
MAHARASHTRA |
09987833994
drhmishra112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safety Health and Welfare Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, Diabetes and hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glimepiride 2mg Plus Oral Resveratrol 1 gram, Atorvastatin 10 mg Plus Oral Resveratrol 1 gram, Telmisartan 20 mg tablet Plus Oral Resveratrol 1 gram |
Once daily for 12 months
Total duration of therapy: 12 months (1 year) |
| Comparator Agent |
Glimepiride 2mg, Atorvastatin 10 mg, Telmisartan 20 mg tablet |
Once daily for 12 months
Total duration of therapy: 12 months (1 year) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diabetes study:
Patients of either gender with known T2DM, aged between 20 and 65 years
Patient with borderline blood lipid abnormality and not taking any hypolipidemic agents
Patient is on stable monotherapy of Glimeperide 2 mg
Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy in management of their T2DM.
Dylipidemia study:
Patients with either sex in the age group of 20-65 years suffering from dyslipidemia
Patient who are on stable therapy of Atorvastatin 10 mg tablet
Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy (Statin) in management of dyslipidemia.
Hypertension study:
Patients of either sex, aged 20-65 yrs
Patients with Stage I hypertension (SBP 140–159 mmHg and DBP 90–99 mmHg)
Patients taking monotherapy of Telmisartan 20 mg
Patient willing to use Plant based therapy (RESVERATROL) with gold standard therapy (Telmisartan 20 mg) in management of hypertension.
|
|
| ExclusionCriteria |
| Details |
Diabetes study:
Patients who are willing to use other antioxidant supplementation rather than RESVERATROL
Patients with type 1 diabetes, pregnant women and lactating mothers
Patients with dyslipidemia and taking lipid lowering therapy including statin
Patients with history of severe heart disease, hepatic and renal dysfunction
Patients taking/requiring beta – blocker and any drug which produce hyperglycemia or hypoglycemia.
Patients with history of allergy with grapes and consume alcohol daily
Dylipidemia study:
Patients who are willing to use other antioxidant supplementation rather than RESVERATROL
Pregnant women and lactating mothers
Patients taking/requiring any drug which affect blood lipid level
Patients with history of diabetes, severe heart disease, hepatic and renal dysfunction
Patients with history of allergy with grapes and consume alcohol daily
Hypertension study:
Patients who are willing to use other plant based therapy rather than RESVERATROL
Patients taking/requiring any drug which affect blood pressure
Pregnant women and lactating mothers
Patients with history of severe heart disease, hepatic and renal dysfunction
Patients with history of allergy with grapes and consume alcohol daily |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in blood sugar level (fasting and fed), lipid profile and SBP and DBP from baseline to end of study visit (12 month) |
At baseline and 12 month |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in blood sugar level (fasting and fed), lipid profile, Hemoglobin A1c and systolic and diastolic blood pressure |
Baseline, at the end of 3 month, 6 month and 9 month |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
16/09/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Rakesh Ojha, Kulkarni Pranesh, Vyas Bhavin. A Randomized Active Controlled Clinical Study to Evaluate Efficacy and Safety of Resveratrol as an Adjuvant Therapy in Patients With Hypertension. Asian Journal of Pharmaceutical and Clinical Research Vol 10 Issue 1 January 2017 Page: 376-379
Rakesh Ojha, Kulkarni Pranesh, Vyas Bhavin. Efficacy and Safety of Resveratrol as an Adjuvant Therapy in Type 2 Diabetes Mellitus Patients: Result of a Randomized Active Controlled Clinical Study. Int J Res Med. 2017; 5(4); 81-87
Rakesh Ojha, Kulkarni Pranesh, Vyas Bhavin. Efficacy and Safety Of Resveratrol as an Adjuvant Therapy in Patients with Dyslipidemia: Result of A Randomized Active Controlled Clinical Study. AJPER January – March 2017, Vol 6, Issue 1 (83-95).
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
As we all know diabetes, dyslipidemia and hypertension is common cause of morbidity and mortality in India. To manage aforesaid disease effectively, often combination therapy and adjusting dose of gold standard therapy from low to high is required to prevent mortality. This may results in long term safely issues and add financial burden to patients and their family. To prevent side effects and financial burden due to combination therapy and high dose of gold standard therapy, there is need of an effective adjuvant therapy which is free from side effects, cost effective and enhances the efficacy of current gold standard therapy without the need of switching to aggressive therapy. Also there is a need of adjuvant therapy which keeps us healthy and useful as prophylaxis for the patients with risk factor of cardiovascular disease. The objective of this study: 1) To evaluate the efficacy and safety of resveratrol as an adjuvant therapy in patients with Diabetes, Dyslipidemia and Hypertension. 2) To determine the effect of resveratrol in prevention of dyslipidemia in patients with type 2 diabetes mellitus (T2DM). Findings: In Diabetes study, a total of 60 T2DM patients with borderline dyslipidemia were analyzed (glimepiride [n=30] and glimepiride plus resveratrol [n=30]). Resveratrol as an adjuvant with glimepiride significantly reduced plasma blood glucose concentration as compared to glimepiride monotherapy during fasting and postprandial conditions (p<0.001). Mean levels of HbA1c were significantly lower in glimepiride plus resveratrol group than glimepiride (p<0.001). Significantly lower mean serum levels of TC, TG and LDL were observed in resveratrol plus glimepiride group than glimepiride (p<0.001). Mean serum levels of HDL was significantly higher in resveratrol plus glimepiride group than glimepiride (p<0.001). Both the study drugs have similar safety profile. In dyslipidemia study, a total of 60 dyslipidemia patients with borderline hypertension were subjected to statistical analysis (atorvastatin [n=30] and atorvastatin plus resveratrol [n=30]). Significantly greater reduction in lipid levels (TC, TG, LDL and VLDL) were observed in patients treated with atorvastatin plus resveratrol when compared to atorvastatin monotherapy (p<0.001). Mean HDL levels were also significantly higher in resveratrol plus atorvastatin group than atorvastatin monotherapy (p<0.001). Both the study drugs have similar safety profile. In hypertension study, a total of 60 hypertensive patients were analysed (telmisartan [n=30] and telmisartan plus resveratrol [n=30]). Significant greater reduction in blood pressure (systolic and diastolic) was observed in telmisartan plus resveratrol group when compared to telmisartan monotherapy group (p<0.001). Both the study drugs have comparable safety profile and found well tolerable. Conclusions: In Diabetes study, resveratrol as an adjuvant therapy was found to be well tolerated and effective in T2DM; and also prevents progression of T2DM induced dyslipidemia. In dyslipidemia study, resveratrol plus atorvastatin was found to be superior over atorvastatin monotherapy in improving lipid levels in dyslipidaemia patients.In hypertension study, resveratrol plus telmisartan was found to be superior over telmisartan monotherapy in reducing systolic and diastolic blood pressure in hypertensive patients. |