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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)

Phase 4
Completed
Conditions
Health Condition 1: null- Dyslipidemia, Diabetes and hypertension
Registration Number
CTRI/2017/04/008384
Lead Sponsor
Rakesh Ojha
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
180
Inclusion Criteria

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 140â??159 mmHg and DBP 90â??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.

Exclusion Criteria

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 â?? 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in blood sugar level (fasting and fed), lipid profile and SBP and DBP from baseline to end of study visit (12 month)Timepoint: At baseline and 12 month
Secondary Outcome Measures
NameTimeMethod
Change in blood sugar level (fasting and fed), lipid profile, Hemoglobin A1c and systolic and diastolic blood pressureTimepoint: Baseline, at the end of 3 month, 6 month and 9 month
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