| CTRI Number |
CTRI/2020/06/025569 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
An open label, prospective clinical comparative study to assess the anti-inflammatory benefit of momordica charantia tablet in metabolic syndrome. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Shri Vidhya |
| Designation |
MD Pharmacology 1st year PostGraduate |
| Affiliation |
PSG INSTITUTE OF MEDICAL SCIENCE AND RESEARCH |
| Address |
Post Graduate Room
Department Of Pharmacology
PSG Institute Of Medical Science And Research
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9345599592 |
| Fax |
|
| Email |
shrivi90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head of the Department of Pharmacology |
| Affiliation |
PSG Institute of Medical science and Research |
| Address |
Department of Pharmacology
PSG Institute of Medical science and Research
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K BHUVANESWARI |
| Designation |
Professor and Head of the Department of Pharmacology |
| Affiliation |
PSG Institute of Medical science and Research |
| Address |
Professor and HOD room
Department of Pharmacology
PSG Institute of Medical science and Research
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9894769934 |
| Fax |
|
| Email |
nandabhuvana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute Of Medical Science And Research Peelamedu Coimbatore 641004 TAMILNADU
|
|
|
Primary Sponsor
|
| Name |
Dr M Shri Vidhya |
| Address |
Post Graduate room
Department of Pharmacology
PSG Institute Of Medical Science And Research Peelamedu
Coimbatore
641004 |
| 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 M SHRI VIDHYA |
PSG Institute Of Medical Science and Research |
Department of Pharmacologyand PG Room
Coimbatore
TAMIL NADU |
9345599592
shrivi90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee PSGIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E138||Other specified diabetes mellituswith unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Momordica Charantia Tablet 1G TDS FOR 3 MONTHS |
TO Study The Anti-Hypertensive Anti-Diabetic And Anti-Lipedemic,Anti-Inflammatory Benefit Of Momordica Tablet As Add On Therapy With The Standard Therapy For Metabolic Syndrome Patients |
| Comparator Agent |
Olmesartan 20MG OD
Atorvastatin 10 MG OD
Metformin 500 MG OD |
To Study The Anti-Hypertensive Anti-Diabetic ,ANTI-lipedemic And Anti-Inflammatory Benefit Of Momordica Charantia Tablet As Add On Therapy With Standard Therapy For Metabolic Syndrome Patients |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical effectiveness of Momordica Charantia Tablet with Standard drug therapy in the newly diagnosed Metabolic Syndrome patients |
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
|
| Outcome |
TimePoints |
| TO IDENTIFY THE ANTI-INFLAMMATORY BENEFIT OF MOMORDICA CHARANTIA TABLET IN PATIENTS WITH METABOLIC SYNDROME USING MARKERS OF OXIDATIVE STRESS SOD,MDA,HS-CRP |
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 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: Metabolic syndrome is the combination of various abnormalities like raised blood sugar,raised blood pressure and decreased HDL cholesterol which is the major health problem that leads to cardiovascular disease.there is triple therapy regimen for the treatment and this study focus on the momordica as add on therapy which also has the property to reduce blood sugar ,blod pressure and cholesterol level inaddition to the property of reducing inflammmation. Material and Methodology: Sample size of 66 patients in 2 groups(33/group)will be randomly assinged through simple randomization to treat with standard drug(Olmesartan 20 mgOD,Metformin 500mgOD and Atorvastatin 10 mg OD )and momordica tablet (commercially available tablet)as add on therapy for a period of 3 months.Baseline parameters like Blood pressure,waist circumference,BMI,Body weight,FBS,PPBS,SOD,MDA,HSCRP HbA1C were done before and after the treatment Result Data were collected and analysed by one way ANOVA and Unpaired t test Conculsion: IHEC Approval This study has been approved by IHEC of PSG INSTITUTE OF MEDICAL SCIENCE AND RESEARCH(affliated to TN MGR MEDICAL UNIVERSITY) COIMBATORE Proposal number:19/332 dated on 6.3.2020 |