Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theranor s.p.r.l
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Outpatients aged > or = 18 years

• Ability and willingness to adhere to the study protocol

• Signed informed consent

• Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?"

• 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.

Exclusion Criteria:

• Specific chronic diseases (autoimmune disease, chronic bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)

• Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.

• Cancer therapy

• Immunosuppressant therapies

• Use of systemic corticosteroids

• A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)

• Any of the common cold symptoms persisting since more than 36 hours

• Use of other homeopathic drugs designed to treat URTIs

• Use of antibiotics, anti-histaminergic drugs or decongestants

• Participation in another clinical trial within one month prior to treatment start

• Previous participation (receipt of randomised treatment) in this study