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Use of Clevira tablets and syrup for cough common cold and Flu infections

An Open Label Balanced Randomized Multicentre Multidose Two Treatment Parallel Comparitive Phase III Clinical Trail To Determine The Safety And Efficacy Of Clevira Manufactured By Apex Laboratories Private Limited India With Standard Supportive Care Treatment In Human Adult Patients With Influenza & Flu A Contagious Respiratory Illness Caused By Influenza Virusses That Infect The Nose Throat And Sometimes The Lungs

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050004
Enrollment
60
Registered
2023-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J09X- Influenza due to identified novelinfluenza A virus

Interventions

Intervention1: Clevira Tablets: 2 tablets Oral Dose Twice a day for 7 to 10 days Intervention2: Clevira Syrup: 10 ml Oral Dose Twice or thrice daily for 7 to 10 days Control Intervention1: Not app

Sponsors

Dr Anoop Austin
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Either sex between the age of 18 to 75 years with an oral temperature of more than 38 C with or without associated rash body pain and joint pain severe headache especially behind the eyes nausea and vomiting Mild to Influenza and other respiratory viral infections Common cold and cough Mumps HPV and Herpes Zoster associated disease as defined by the WHO With Viral fever accompanied by thrombocytopenia with a platelet count between 80000 to 100000 micro litre along with stable vitals like pulse and blood pressure Female patients who tested negative for pregnancy (up to two weeks prior to the study)

Exclusion criteria

Exclusion criteria: Patients with Dengue hemorrhagic fever grade III and IV Patients with platelet count less than 80000 micro litre Pregnant or lactating women Patients who have received blood or blood products transfusion during the current illness Patients with thrombocytopenia Purpura (ITP) Leukemia Hemophilia Patients with serum ALT level 3 times higher than the upper limit of the normal range and Impaired renal function with serum creatinine > 1.5 mg/dl (males) and > 1.4 mg/dl (females) Patients who were hypersensitive to any of the components of the formulation

Design outcomes

Primary

MeasureTime frame
Difference between Clevira Syrup and standard treatment groups in Common cold and cough on baseline and Day 10 At the end of the study Haematology and vital signs (blood pressure, radial pulse rate, body temperature and wellbeing status) will be recordedTimepoint: Day 0, Day 1 to Day 10

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactDr Nagarajan P B A M S

NR Ayurvedic Hopsital

drnagap@yahoo.co.in

Outcome results

None listed

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