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A study to compare the reduction of blood sugar,blood pressure,cholesterol and inflammatory benefits momordica charantia tablet with regular therapy in metabolic syndrome patients

Phase 2
Conditions
Health Condition 1: E138- Other specified diabetes mellituswith unspecified complications
Registration Number
CTRI/2020/06/025569
Lead Sponsor
Dr M Shri Vidhya
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients already on OLmesartan 20mg OD and Metformin 500mgOD and Atorvastatin 10 mg OD

2.Prediagnosed Metabolic syndrome patients with Diet and life style modifications

3.Age >25 years

4.Both Male and Female

5.Triglycerides >150 mg/dl

6.FBS >100 mg/dl

7.PPBS >140 mg/dl

8.BP >130/85 mmHg

9.HbA1C -5.7-6.4

Exclusion Criteria

1.Patients with Coronary artery disease /storke

2.Patients with

Aspirin/NSAIDS/Steroid/Febuxostat/Statin/Thaizide

3.Patients with Injuries/Arthritis/Hypothyroidism/Nephrotic syndrome

4.Patients on native treatment/ayurveda/siddha treatment/on any alternative treatment

5.Pregnancy/Lactation/Heavy Alcohol Consumption

6.Blood pressure >150/100mmHg

7.HbA1C >7.4

8.Triglycerides >400 mg/dl

9.Patients on more than one drug for hypertension other than Olmesartan 20mg OD and drugs other than Metformin 500MG OD for Diabetes and drugs for elevated cholesterol other than Atorvastatin 10 mg OD

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the clinical effectiveness of Momordica Charantia Tablet with Standard drug therapy in the newly diagnosed Metabolic Syndrome patientsTimepoint: Pre Medication Parmeters -BP,Body Weight,Waist Circumference,BMI,FBS,PPBS,HbA1C,SOD,MDA,HS-CRP will be done 1 day prior to intiating Medications
Secondary Outcome Measures
NameTimeMethod
TO IDENTIFY THE ANTI-INFLAMMATORY BENEFIT OF MOMORDICA CHARANTIA TABLET IN PATIENTS WITH METABOLIC SYNDROME USING MARKERS OF OXIDATIVE STRESS SOD,MDA,HS-CRPTimepoint: POST MEDICATION PARAMETERS-BP,BMI,BODYWEIGHT,WAIST CIRCUMFERENCE,FBS PPBS,HbA1C,HS CRP,SOD,MDA AFTER 3 MONTHS OF MEDICATION 1 DAY LATER PARAMETERS WILL BE DONE
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