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Safety of twice versus thrice daily hydrocortisone dose in glucocorticoid induced Adrenal Insufficiency patients: A Randomized Control Trial

Safety and efficacy of twice daily versus thrice daily hydrocortisone regimen in glucocorticoid induced Adrenal Insufficiency patients: A Randomized Control Trial - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084167
Enrollment
30
Registered
2025-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E273- Drug-induced adrenocortical insufficiency

Interventions

Intervention1: 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 Intervention2: Gr

Sponsors

Dr Prince Rastogi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above 2. Both Male and Female 3. Diagnosed with GIAI 4. Deemed to be started on hydrocortisone replacement therapy.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1.To compare cortisol day curve AUC at 4 weeks and 12 weeks which align with Physiological day curve AUC of normal healthy controls.Timepoint: Baseline visit at week 1 2nd visit at week 4th 3rd visit at week 12th—

Secondary

MeasureTime frame
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.Timepoint: Baseline visit at week 1 2nd visit at week 4th 3rd visit at week 12th—

Countries

India

Contacts

Public ContactDr Ravindra Shukla

AIIMS JODHPUR

princerastogi4@gmail.com7668281582

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026