Studying the usefullness of Melatonin supplement in the treatment of Chronic urticaria

Efficacy and Safety of Melatonin as an add-on Therapy to Antihistamines in Chronic Urticaria: A Randomized Double-Blind Placebo-Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092150

Enrollment

Registered

2025-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: L501- Idiopathic urticaria

Interventions

Intervention1: Melatonin Group: Melatonin 3mg oral supplementation 2-3 hours before bedtime for a period of 8 weeks Control Intervention1: Placebo group : oral similar placebo supplementation for a pe

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients above 18 years of age diagnosed with Chronic urticaria as defined by 2022 EAACI/GA LEN/EuroGuiDerm/APAAACI guidelines

Exclusion criteria

Exclusion criteria: 1. Patients with sleep/seizure disorders 2. Patients on CNS depressants like antipsychotics, antiepileptics 3. Pregnant and lactating women 4. Patients with liver/ renal impairment 5. Known melatonin allergy or intolerance

Design outcomes

Primary

Measure	Time frame
Urticaria severity (measured using UAS7 score)Timepoint: 4 and 8 weeks	—

Secondary

Measure	Time frame
Sleep quality (measured using PSQI) Quality of life (measured using DLQI) Timepoint: 4 and 8 weeks	—

Countries

India

Contacts

Public ContactDr Sushmitha Dharani Sankar

Aarupadai veedu medical college and hospital

sushmithajipmer@gmail.com9786892911

Outcome results

None listed

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