This trial will compare to a placebo (inactive treatment) the efficacy and safety of a mixture of antibodies raised against a key protein of the immune system (TLR3) used in homoepathic dilutions in patients suffering from common cold. The trial will be conducted in multiple centres. Treatment assignment will be done by chance.

Phase 1

• Conditions: Viral upper respiratory tract infections; MedDRA version: 14.1Level: PTClassification code 10022004Term: Influenza like illnessSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: LLTClassification code 10010106Term: Common coldSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10000938Term: Acute nasopharyngitis (common cold)System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10046300Term: Upper respiratory infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000057-31-BE
• Lead Sponsor: THERANOR sprl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a) Outpatients aged > or = 18 years
b) Ability and willingness to adhere to the study protocol
c) Signed informed consent
d) Self-reported recently emerged symptoms of common cold: answer Yes to the question Do you believe that you are coming down with a cold?
e) At least one of the following 4 common cold symptoms: sneezing, runny nose, nasal obstruction and/or sore throat, with no limitations of symptom severity.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

a) Specific chronic diseases (autoimmune disease, chronic
bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)
b) Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
c) Cancer therapy
d) Immunosuppressant therapies
e) Use of systemic corticosteroids
f) A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)
g) Any of the common cold symptoms persisting since more than 36 hours
h) Use of other homeopathic drugs designed to treat URTIs
i) Use of antibiotics, anti-histaminergic drugs or decongestants
j) Participation in another clinical trial within one month prior to treatment start
k) Previous participation (receipt of randomised treatment) in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified