Study to assess the Safety and effect of Wikoryl DS oral suspension in children having common cold with fever

A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Wikoryl DS oral suspension in children suffering from common cold associated with fever

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/10/046178

Enrollment

240

Registered

2022-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Wikorly DS Oral Suspension: 2.5 ml to 5ml three to four times a day for 5 days Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 2-12 years of age. (12-40 Kg body weight) 2. Genders Eligible for Study: both Males and Females 3. Patients with clinical diagnosis of common cold associated with fever. These symptoms may include rhinorrhea, nasal congestion, sneezing etc. 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 DS Oral SuspensionTimepoint: Day 6	—

Secondary

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

Countries

India

Contacts

Public ContactDr Devendra Khandke

Alembic Pharmaceuticals Limited

da.khandke@alembic.co.in9769461291

Outcome results

None listed

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