A Study to Assess How Well Karvol Plus Capsules Relieve Nasal Congestion and Related Symptoms in People with Common Cold, Allergies, or Sinusitis

A Prospective, Single-Arm, Real-World Study to Evaluate of the Efficacy and Safety of Karvol Plus Capsules in the Management of Nasal Congestion and Associated Symptoms in Patients with Common Cold, Allergic Rhinitis or Sinusitis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091301

Enrollment

250

Registered

2025-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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] Health Condition 2: J01- Acute sinusitis Health Condition 3: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Karvol Plus Capsule: Take one capsule thrice daily of Karvol Plus for 5 days, or as often as needed depending on the severity of symptoms. For morning use, snip off the tip of the cap

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 65 years. 2. Onset of nasal congestion and associated symptoms due to common cold, allergic rhinitis, or sinusitis within the past 48 hours prior to enrolment. 3. Willing and able to provide written informed consent. 4. Willing and able to comply with study procedures, including follow-up assessments as required by the study protocol.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or allergy to any of the components of Karvol Plus capsules (e.g., menthol, camphor, eucalyptol). 2. Patients with known history of severe respiratory comorbidities, such as uncontrolled asthma or chronic obstructive pulmonary disease (COPD). 3. Patients currently receiving other nasal decongestants (topical or systemic) within the last 48 hours that may interfere with the assessment of Karvol Plus effectiveness. 4. Any other condition or therapy that, in the investigator s opinion, may interfere with the study outcomes or pose a safety risk.

Design outcomes

Primary

Measure	Time frame
Change in Total Nasal Symptom Score (TNSS).Timepoint: Day 0 to Day 5	—

Secondary

Measure	Time frame
Reduction in individual symptoms, including nasal congestion, runny nose, nasal itching, sneezing, and sleep disturbance.Timepoint: Day 0 to Day 5;Time to first noticeable relief after using Karvol Plus.Timepoint: Day 0 to Day 5;Patient-reported satisfaction with treatment effectiveness.Timepoint: Day 5;Change in cough severity and impactTimepoint: Day 0 to Day 5;Change from baseline in the severity of heaviness in head , as measured by the subject using an 11-point Numeric Rating Scale (NRS).Timepoint: Day 0 to Day 5	—

Measure

Time frame

Reduction in individual symptoms, including nasal congestion, runny nose, nasal itching, sneezing, and sleep disturbance.Timepoint: Day 0 to Day 5;Time to first noticeable relief after using Karvol Plus.Timepoint: Day 0 to Day 5;Patient-reported satisfaction with treatment effectiveness.Timepoint: Day 5;Change in cough severity and impactTimepoint: Day 0 to Day 5;Change from baseline in the severity of heaviness in head , as measured by the subject using an 11-point Numeric Rating Scale (NRS).Timepoint: Day 0 to Day 5

—

Countries

India

Contacts

Public ContactDr Abhijit Anil Trailokya

Indoco Remedies Limited

abhijit.trailokya@indoco.com8080042460

Outcome results

None listed

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