Post marketing study to evaluate the Safety and Efficacy of Wikoryl tablets in adult patients

A Multicentric, Non-Randomized, Open label, Non-Comparative, Active post marketing surveillance to evaluate the Safety and Efficacy of Alembic Wikoryl tablets in adults suffering from common cold

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/04/042134

Enrollment

240

Registered

2022-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

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: Alembic Wikoryl tablets, FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg in each table: 1 tablet, 3 to 4 times in a day for 5 days Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed clinical diagnosis of common cold 2. Patients who 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 Alembic Wikoryl tabletsTimepoint: Baseline (Day 1) and Day 6	—

Secondary

Measure	Time frame
Change in symptom scores for fever, rhinorrhea, nasal congestion and sneezing (Rated on 4 point scale 0-3)Timepoint: Baseline and 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