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CTRI Number  CTRI/2025/08/092150 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Studying the usefullness of Melatonin supplement in the treatment of Chronic urticaria 
Scientific Title of Study   Efficacy and Safety of Melatonin as an add-on Therapy to Antihistamines in Chronic Urticaria: A Randomized Double-Blind Placebo-Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushmitha Dharani Sankar 
Designation  Assistant Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of Dermatology, Aarupadai veedu medical college and hospital, Kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9786892911  
Fax    
Email  sushmithajipmer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushmitha Dharani Sankar 
Designation  Assistant Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of Dermatology, Aarupadai veedu medical college and hospital, Kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9786892911  
Fax    
Email  sushmithajipmer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sushmitha Dharani Sankar 
Designation  Assistant Professor 
Affiliation  Aarupadai veedu medical college and hospital 
Address  Department of Dermatology, Aarupadai veedu medical college and hospital, Kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9786892911  
Fax    
Email  sushmithajipmer@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital 
Address  Kirumampakkam, Puducherry- 607403 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushmitha Dharani Sankar  Aarupadai veedu medical college and hospital, Kirumampakkam   Department of Dermatology, Venereology and Leprosy
Pondicherry
PONDICHERRY 		 9786892911

sushmithajipmer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AVMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melatonin Group  Melatonin 3mg oral supplementation 2-3 hours before bedtime for a period of 8 weeks 
Comparator Agent  Placebo group   oral similar placebo supplementation for a period of 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All adult patients above 18 years of age diagnosed with Chronic urticaria as defined by 2022 EAACI/GA²LEN/EuroGuiDerm/APAAACI guidelines 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Urticaria severity (measured using UAS7 score)  4 and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep quality (measured using PSQI)
Quality of life (measured using DLQI)
 		 4 and 8 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 3 
Date of First Enrollment (India)   18/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

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.

 
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