Respiratory Infections in Iranian Pilgrims: A Randomized Clinical Trial

Efficacy and Safety of IMOD and Arbidol in the Prophylaxis of Upper Respiratory Infections in Iranian Pilgrims: A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201112124076N5

Enrollment

400

Registered

2013-01-01

Start date

2013-09-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Acute upper respiratory infections. Acute upper respiratory infections

Interventions

Intervention 1: Group 1: Cap. Arbidol 100 mg, 2 capsules daily for 10 days + Cap. IMODTM 120mg, 2 capsules daily for 10 days. Intervention 2: Group2: Cap. Arbidol 200 mg, 2 capsules daily for 10 da

Treatment - Drugs

Group 1: Cap. Arbidol 100 mg, 2 capsules daily for 10 days + Cap. IMODTM 120mg, 2 capsules daily for 10 days.

Group2: Cap. Arbidol 200 mg, 2 capsules daily for 10 days + Cap. IMODTM placebo, 2 capsules daily for 10 days

Group 3: Cap. Arbidol placebo, 2 capsules daily for 10 days + Cap. IMODTM 120mg, 2 capsules twice daily for 10 days

Group 4: control group: Cap. Arbidol placebo, 2 capsules daily for 10 days + Cap. IMODTM placebo, 2 capsules daily for 10 days

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusions Criteria 1- Hajjis with age =18 years who intend to visit Mecca before going to Medina for Hajj-ul-Tamatoo. 2- Individuals without any respiratory infection sign and symptom. 3- Women of childbearing age who use contraception. 4- Individuals with written informed consent Exclusions Criteria 1- Individuals with at least one respiratory symptom (cough, sore throat, or nasal symptom). 2- Individuals with at least one constitutional symptom (fever, malaise, myalgia, sweats or chills, or fatigue). 3- Suspected bacterial infection or recent use of antimicrobial drugs. 4- Pregnancy or breastfeeding. 5- Concurrent use of antiviral medications. 6- Underlying conditions such as diabetes for which influenza immunization is currently recommended

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Caugh. Timepoint: 10 days. Method of measurement: physical examination.;Rhinitis. Timepoint: 10days. Method of measurement: Physical examination.;Sore Throat. Timepoint: 10days. Method of measurement: Physical examination.	—

Secondary

Measure	Time frame
Headache. Timepoint: during 10 days of intervention. Method of measurement: physical examination.;Chills. Timepoint: During 10 days of intervention. Method of measurement: Physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ahmad Seyed Alinaghi

Iranian Research center for HIV/AIDS

s_a_alinaghi@yahoo.com+98 21 6694 7984

Outcome results

None listed

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