TO STUDY EFFECT OF MIRTAZAPINE IN DIABETIC PATIENTS HAVING ITCHING

Efficacy & Safety of Mirtazapine in Diabetic Patient with Pruritus: A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078069

Enrollment

Registered

2024-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Mirtazapine: Mirtazapine 7.5 mg before bed till 12 weeks Control Intervention1: Standard of Care: Standard of Care include Moisturizers Cream and lotions

Eligibility

Inclusion criteria

Inclusion criteria: 1. patient of either sex and age more than 18 years. 2.persistant pruritus for 6 weeks or more. 3.patient diagnosed with diabetic pruritus and having HbA1cmore than 7.5.

Exclusion criteria

Exclusion criteria: 1. Patients with AST and ALT three times above the normal level. 2. Creatinine clearance (CrCl) less than 30 ml/min/1.73m2 . 3. Patients with pruritus of known dermatological causes such as liver disease, Psoriasis, Lichen planus, Scabies, etc. 4. Pregnant and lactating women. 5. Patients taking opioids for therapeutic purpose. 6. History of allergy / hypersensitivity to Mirtazapine. 7.Patient already receiving pregabalin, gabapentin or other therapy. 8.Use of Monoamine oxidase inhibitors (MAO inhibitors).

Design outcomes

Primary

Measure	Time frame
to compare the efficacy of mirtazapine in pruritus among diabetic patients to standard care group measured by 50 % reduction in visual analogue scale for pruritus after 12 weeks of therapy from baseline.Timepoint: 4,8,12 week	—

Secondary

Measure	Time frame
1.to evaluate the efficacy of mirtazapine in pruritus among diabetic patients using 5D pruritus scale from baselineTimepoint: 4,8,12 week;2.to evaluate change in dermatology life quality index from baseline.Timepoint: 4,8,12 week;3.to evaluate change in quality of sleep using epworth sleepiness scale from baselineTimepoint: 4,8,12 week;4.to evaluate change in anxiety score using hamilton anxiety rating scale from baseline.Timepoint: 4,8,12 week;5.to evaluate safety (hba1c & FBS) and any adverse effect of mirtazapineTimepoint: 4,8,12 week	—

Measure

Time frame

1.to evaluate the efficacy of mirtazapine in pruritus among diabetic patients using 5D pruritus scale from baselineTimepoint: 4,8,12 week;2.to evaluate change in dermatology life quality index from baseline.Timepoint: 4,8,12 week;3.to evaluate change in quality of sleep using epworth sleepiness scale from baselineTimepoint: 4,8,12 week;4.to evaluate change in anxiety score using hamilton anxiety rating scale from baseline.Timepoint: 4,8,12 week;5.to evaluate safety (hba1c & FBS) and any adverse effect of mirtazapineTimepoint: 4,8,12 week

—

Countries

India

Contacts

Public ContactDrMohit dadhich

aiims jodhpur

mohit9460dadhich@gmail.com09460912576

Outcome results

None listed

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