Post marketing study to evaluate the Safety and Efficacy of Wikoryl Drops in infants (1 year)

A Multicentric, non-randomized, open label, non-comparative, active post marketing surveillance (PMS) to evaluate the safety and efficacy of Wikoryl Oral Drops in infants suffering from Common cold with fever

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/12/039024

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 2.5 mg and Chlorpheniramine Maleate 1 mg per ml: 10-20 drops three times a day for 5 days Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: up to 1 year (weight: 2.5-12 kg) 2. Genders Eligible for Study: both Males and Females 3. Patients with confirmed clinical diagnosis of Common cold with fever 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 DropsTimepoint: 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