Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Study Evaluating the Efficacy and Safety of Early Self-Treatment of Viral Upper Respiratory Tract Infections With Homeopathic Oral Antibodies to the TLR3 FYW Peptide (TAO1) (ESTUAR)

NCT01651715 Phase 1/Phase 2 COMPLETED

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

Details

Lead sponsor	Theranor s.p.r.l
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	232
Start date	2012-09
Completion	2013-08

Conditions

• Common Cold

Interventions

• TAO1, oral homeopathic antibodies

Primary outcomes

• Severity of symptoms of common cold — Since start of symptoms of common cold up to the visit 3 (day 10-14)
  Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (sum of all WURSS scores over the follow-up). The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) is a validated tool to evaluate the duration and severity of common cold. It is constituted of twenty-one categorical questions (Likert-type 7-level severity scale).

Countries

Belgium