| CTRI Number |
CTRI/2015/09/006171 [Registered on: 09/09/2015] Trial Registered Prospectively |
| Last Modified On: |
03/09/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of licorice on patients with gene polymorphism |
|
Scientific Title of Study
|
11 beta HSD-1 gene polymorphism in patients with type 2 diabetes, metabolic syndrome and PCOS- Effect of carbenoxolone (Licorice) on anthropometric and metabolic parameters of patients with this polymorphism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabha Adhikari |
| Designation |
Professor of Medicine |
| Affiliation |
Kasturba Medical college, Mangalore, Manipal university, Karnataka |
| Address |
Dept of Medicine
Kasturba Medical College
Attavar
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880991290 |
| Fax |
|
| Email |
prabha.raghuveer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Adhikari |
| Designation |
Professor of Medicine |
| Affiliation |
Kasturba Medical college, Mangalore, Manipal university, Karnataka |
| Address |
Dept of Medicine
Kasturba Medical College
Attavar
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880991290 |
| Fax |
|
| Email |
prabha.raghuveer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabha Adhikari |
| Designation |
Professor of Medicine |
| Affiliation |
Kasturba Medical college, Mangalore, Manipal university, Karnataka |
| Address |
Dept of Medicine
Kasturba Medical College
Attavar
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880991290 |
| Fax |
|
| Email |
prabha.raghuveer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Science and Technology
|
| Research society for the study of diabetes in India
|
|
|
Primary Sponsor
|
| Name |
RSSDI |
| Address |
No.B-7,KEB Layout,1st Main,Bannerghatta Main Road,Bengaluru,Karnataka 560029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DST INSPIRE |
Dept of Science and Technology
Technology Bhavan
New Mehrauli road
New Delhi
110016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabha Adhikari |
Kasturba Medical College Hospital, Mangalore |
Dept of Medicine
Kasturba Medical College hospital
Attavar
Mangalore
Dakshina Kannada
KARNATAKA |
9880991290
prabha.raghuveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal University Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetics, metabolic syndrome and polycystic ovary syndrome subjects showing 11 beta HSD-1 gene polymorphism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Licorice |
orally administer 250 mg licorice, four times daily for 3 weeks. |
| Comparator Agent |
Placebo |
orally administer 250 mg placebo, four times daily for 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who sign informed consent
Type 2 diabetics confirmed by ADA criteria
Metabolic syndrome subjects confirmed by IDF criteria
Polycystic ovary syndrome subjects confirmed by rotterdam criteria |
|
| ExclusionCriteria |
| Details |
Type 1 diabetes
Diabetics on insulin
Subjects with HbA1C>9.5%, FBS>200 mg/dl,
BP>160/100,eGFR>30%
Known hypokalemia
Oedema
Women of child bearing potential
Currently on alcohol abuse |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change from baseline FBS, PPBS and fructosamine.
2.Proportion of patients who maintain good short term glycemic control without the need of additional antidiabetic medication.
3.Change from baseline weight, waist circumference 4.Change from baseline in total cholesterol, LDL, HDL, triglyceride |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who show hypokalemia, oedema, elevation of blood pressure of 5 mmHg or more and other side effects |
Baseline and every week upto 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2015 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be done after the completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes has become one of the major causes of morbidity with more than 285 millions worldwide having this condition. The prediabetic conditions like metabolic syndrome (metS) and polycystic ovary syndrome (PCOS) are also increasing in prevalance. Type 2 diabetes, metS and PCOS show charcteristic insulin resistance in subjects, which is why they are closely related. Subjects with these conditions are characterised by cushingoid features. 11 beta HSD enzyme which has a major role in glucocorticoid (GC) metabolism may alter GC action due to the polymorphism in the gene encoding them.
Recently much attention has been given to the pharmacological manipulation of cortisol metabolism as therapeutic strategy. 11 B HSD-1 inhibitor like licorice is known to decrease local GC generation, decrease blood glucose, lipids and improve insulin sensitivity. Licorice is been used in medicine for more than 4000 years. It is used as anti-ulcer,anti-inflammatory agent, demulcent, expectorant, laxative, sweetener, bronchodilator,diuretic,anti-pyretic,rejuvenator, skin fairness,etc.
Our current study is to explore the role of 11 B HSD-1 gene polymorphisms in subjects with type 2 diabetes, metS and PCOS and to study the pharmacological use of licorice (carbenoxolone) in treatment of these abnormalities by their interference in cortisol metabolism.
|