| CTRI Number |
CTRI/2026/02/104760 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of 50g of glucose versus 25g of glucose in treating hypoglycemia |
|
Scientific Title of Study
|
Comparison of 50g versus 25g glucose in achieving euglycemia in hypoglycemic patients presenting to emergency department in tertiary care centre during 4 hour observation period: A double blinded RCT |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divendu Bhushan |
| Designation |
Associate professor and HOD emergency medicine AIIMS PATNA |
| Affiliation |
AIIMS PATNA |
| Address |
AIIMS PATNA emergency medicine department ground floor IPD buildings
Patna
BIHAR
801507
India |
| Phone |
9661216010 |
| Fax |
|
| Email |
drdivendubhushan@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divendu Bhushan |
| Designation |
Associate professor and HOD emergency medicine AIIMS PATNA |
| Affiliation |
AIIMS PATNA |
| Address |
AIIMS PATNA emergency medicine department ground floor IPD buildings
BIHAR
801507
India |
| Phone |
9661216010 |
| Fax |
|
| Email |
drdivendubhushan@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divendu Bhushan |
| Designation |
Associate professor and HOD emergency medicine AIIMS PATNA |
| Affiliation |
AIIMS PATNA |
| Address |
AIIMS PATNA emergency medicine department ground floor IPD buildings
BIHAR
801507
India |
| Phone |
9661216010 |
| Fax |
|
| Email |
drdivendubhushan@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashish Ranjan |
| Address |
emergency medicine department IPD building ground floor AIIMS PATNA, Patna, Bihar, India, PIN code-801507 |
| 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 Ashish Ranjan |
AIIMS PATNA emergency medicine department |
AIIMS PATNA emergency medicine department ground floor of IPD buildings
Patna
BIHAR |
8825341352
ashish14303@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS-P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E162||Hypoglycemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
glucose |
25 gm IV glucose IV stat and as required within 4 hours |
| Intervention |
glucose |
50 gm IV stat and as required within 4 hours |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patient whose screening RBS on presentation is less than 70 mg/dl |
|
| ExclusionCriteria |
| Details |
patient not giving consent to participate |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recurrence of hypoglycemia |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean glucose requirements in diabetic and non diabetic group |
4 hours |
| adverse event |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, double blinded, parallel group, single center study comparing the safety and efficacy of 50 gm of glucose vs 25 gm of glucose in hypoglycemic patient presenting to tertiary care center. The primary outcome is to compare the recurrence of hypoglycemia in 50 gm vs 25 gm IV glucose in achieving euglycemia in adult hypoglycemia patient during 4hr observation period. secondary outcome is to measure the mean glucose requirement in diabetic and non diabetic in both group. |