Post marketing study to evaluate the Safety and Efficacy of Wikoryl Oral Suspension in children

A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl Oral Suspension in children of common cold with fever or allergic rhinitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/12/039023

Enrollment

240

Registered

2021-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: J00- Acute nasopharyngitis [common cold]

Interventions

Intervention1: FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 1 mg per 5 ml.: 5ml - 10 ml 3 to 4 times a day for 5 days Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 2-12 years of age. (6 -40 Kg body weight) 2. Genders Eligible for Study: both Males and Females 3. Patients with confirmed clinical diagnosis of Common cold with fever or allergic rhinitis. 4. Patients whose guardians can adhere to the Protocol

Exclusion criteria

Exclusion criteria: 1. Patients known to be hypersensitive to investigational product 2. Patients with severe hepatic or renal dysfunction

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of Wikoryl Oral SuspensionTimepoint: Day 6	—

Secondary

Measure	Time frame
Change in symptom scores for fever, rhinorrhea, nasal congestion and sneezingTimepoint: Day 6	—

Countries

India

Contacts

Public ContactDr Pradip N Gore

Alembic Pharmaceuticals Limited

Pradip.gore@alembic.co.in9923404398

Outcome results

None listed

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