A Late-Stage Clinical Study to Compare the Safety and Effectiveness of DIOMINIC-DCA Tablet with Two Commonly Used Cold Medicines MAXTRA & DOLOPAR in Adults with the Common Cold.

An Assessor blind, Randomized, Open label, Multicenter, Comparative Phase IV clinical study to compare the safety and efficacy of DIOMINIC - DCA Tablet (containing Chlorpheniramine Maleate 4mg, Phenylephrine Hydrochloride 10mg, Caffeine Anhydrous 30mg, Paracetamol 500mg) with Maxtra tablet (Containing Chlorpheniramine Maleate 4mg+Phenylephrine Hydrochloride 10mg) and DOLOPAR Tablet (Containing Caffeine 25 mg + Paracetamol 500mg) in adult patient with common cold. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109696

Enrollment

200

Registered

2026-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: DIOMINIC - DCA Tablet: Dosage: Chlorpheniramine Maleate 4mg, Phenylephrine Hydrochloride 10mg, Caffeine Anhydrous 30mg, Paracetamol 500mg Dose: TID, Duration: 5 Days, Mode of Administra

2. Dosage: Caffeine 25mg + Paracetamol 500mg Dose: TID Duration: 5 DAYS Mode of Administration: Oral

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have given their written informed consent to participate voluntarily and understand to adhere to protocol for completion of study. 2. Male and female of age between 18 to 65 years. 3. Patients is able to take oral medication and willing to adhere to schedule of treatment. 4. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e., abstinence, intrauterine device [IUD], or partner agreeing to use male-condom). 5. If male, must agree to use a reliable contraception method (i.e., abstinence, condom or partner using an IUD). 6. Patients with symptoms of common cold of recent onset (for more than 6 hours and less than 36 hours). 7. Patients who present a rating of greater than 6 on the Modified Jacksons Score by blinded assessor. 8. Patients must agree to not consume alcohol, any other substance of abuse during their participation in the trial.

Exclusion criteria

Exclusion criteria: 1. Active participation in any other clinical trial or in last three months. 2. Known allergy to the study drugs used in the trial. 3. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, neurological, psychiatric, endocrine, immunological or haematological disorders or malignancy or auto-immune disease as judged by the investigator. 4. Patients with known renal or hepatic dysfunction. 5. Any history of seasonal or perennial allergic rhinitis. 6. Patients who have taken any treatment for the presenting symptom 48 hours before the screening. 7. Any history of drug abuse /chronic alcoholism. 8. Use of monoamine oxidase inhibitors or barbiturates. 9. Patients on any other treatment or herbal remedies for the common cold. 10. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the patientâ??s participation in the study.

Design outcomes

Primary

Measure	Time frame
Comparison of percentage of patients who shows treatment emergent adverse event between treatment arms.Timepoint: On Baseline, Day 3 & Day 5.	—

Secondary

Measure	Time frame
Comparison of percentage reduction in the Modified Jacksonâ??s Score between treatment arms. Comparison of the percentage of patients who showed a need for any other medication/treatments for the relief of the cold symptoms. Percentage of population requiring rescue medication. Timepoint: On Baseline, Day 3 & Day 5.	—

Countries

India

Contacts

Public ContactDr Gunjan Shah

Brillex Clinical Research Pvt. Ltd.

gunjanshah@brillexcro.com918980235444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026

A Late-Stage Clinical Study to Compare the Safety and Effectiveness of DIOMINIC-DCA Tablet with Two Commonly Used Cold Medicines MAXTRA &amp; DOLOPAR in Adults with the Common Cold.