| CTRI Number |
CTRI/2025/04/084167 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety of twice versus thrice daily hydrocortisone dose in glucocorticoid induced Adrenal Insufficiency patients: A Randomized Control Trial |
|
Scientific Title of Study
|
Safety and efficacy of twice daily versus thrice daily hydrocortisone regimen in glucocorticoid induced Adrenal Insufficiency patients: A Randomized Control Trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prince Rastogi |
| Designation |
Senior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Endocrinology OPD room no 136 First Floor AIIMS Jodhpur Rajasthan India 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7668281582 |
| Fax |
|
| Email |
princerastogi4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prince Rastogi |
| Designation |
Senior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Endocrinology OPD room no 136 First Floor AIIMS Jodhpur Rajasthan India 342005
RAJASTHAN
342005
India |
| Phone |
7668281582 |
| Fax |
|
| Email |
princerastogi4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Shukla |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Endocrinology OPD room no 136 First Floor AIIMS Jodhpur Rajasthan India 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8697190025 |
| Fax |
|
| Email |
shuklar@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur Basni Industrial Area Phase 2 Rajasthan India 342005 |
|
|
Primary Sponsor
|
| Name |
Dr Prince Rastogi |
| Address |
Department of Endocrinology, OPD room no 136 First Floor AIIMS Jodhpur Rajasthan 342005 |
| 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 PRINCE RASTOGI |
AIIMS JODHPUR HOSPITAL |
DEPARTMENT OF ENDOCRINOLOGY OPD ROOM NO 135 136 147 148 149 150 AND AIIMS IPD BLOCK AIIMS JODHPUR BASNI RAJASTHAN INDIA 342005
Jodhpur
RAJASTHAN |
7668281582
princerastogi4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR INSTITUTIONAL ETHICS COMMITTEE CLINICAL TRIAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E273||Drug-induced adrenocortical insufficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Hydrocortisone thrice a day dosing |
Hydrocortisone replacement therapy with thrice a day dosing schedule with doses 10mg-5mg-5mg at 6,12,16 hours time period |
| Intervention |
Group 2: Hydrocortisone twice a day dosing |
Hydrocortisone replacement therapy with twice a day dosing schedule with doses 10mg - 5mg at 6,16 hours time period |
| Comparator Agent |
Healthy Controls |
Cortisol Day Curve will be plotted from 5 healthy volunteers at six different timepoints of the day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years and above
2. Both Male and Female
3. Diagnosed with GIAI
4. Deemed to be started on hydrocortisone replacement therapy. |
|
| ExclusionCriteria |
| Details |
1. Adrenal insufficiency patients other than GIAI were excluded
2. Pregnant and lactating females
3. Patients on combined oral contraceptive pills or opioids
4. Patients on anti-epileptic medications or current ATT intake
5. Patients of CKD (eGFR lesser than 60 ml/min/1.73 m2 or serum creatinine greater than 1.5 mg/dL)
6. Hepatic dysfunction with ALT or AST greater than 3x ULN
7. History of any systemic infection in last 4 weeks
8. History of pituitary disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare cortisol day curve AUC at 4 weeks and 12 weeks which align with Physiological day curve AUC of normal healthy controls. |
Baseline visit at week 1
2nd visit at week 4th
3rd visit at week 12th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess glycemic status HBA1c, FBS in the patients at baseline, 4 weeks and 12 weeks and 24 hour urine free cortisol in the patients at 4 and 12 weeks.
2. To compare the body weight, waist circumference, body composition parameters at baseline, 4 weeks and at 12 weeks .
3. To study the effect of Hydrocortisone Replacement therapy on the quality of life in patients with Glucocorticoid induced Adrenal Insufficiency.
4. To study the effect of Hydrocortisone Replacement therapy on DHEAS, Serum Electrolytes, hsCRP, thyroid function test and lipid profile.
5. To assess autonomic function tests at baseline and at 12 weeks.
6. Incidence of hospitalization and Steroid withdrawal syndrome events. |
Baseline visit at week 1
2nd visit at week 4th
3rd visit at week 12th |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/04/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 will help in selecting better regimen based
on safety and efficacy of hydrocortisone in glucocorticoid induced adrenal
insufficiency patients. So with this study, we expect to see improvement in
morbidity associated with over or under treatment with hydrocortisone therapy. |