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

After ethical clearance, written informed consent will be obtained from the study participants. Patients clinically diagnosed as chronic urticaria ie., urticaria lasting for more than six weeks duration will be enrolled. Patients will undergo a thorough clinical evaluation including history, examination and baseline screening tests. Urticaria severity will be assessed using the UAS7 score and Dermatology Life Quality Index (DLQI). Sleep quality will be assessed using the Pittsburgh sleep quality index (PSQI). Baseline melatonin levels will be assessed by Enzyme-Linked Immunosorbent Assay (ELISA).

The study participants will be randomly allocated in two groups. In one group, the patients will be asked to take oral melatonin supplement 3mg 3-4 hours before bedtime, in addition to routine antihistamines. Another group will get a placebo in addition to their routine antihistamines.

Both the groups will be followed and assessed for clinical response at 4 weeks and 8 weeks using the DLQI, Pittsburgh sleep quality index and UAS7 score. At the end of 8 weeks, melatonin levels will be assessed in both groups.