Evaluation of the effectiveness of Lactogum and Coldanese in preventing flu-like symptoms: A cluster randomized phase 3 clinical trial without blinding.

Evaluation of efficacy of Lactogum and coldanese on prevention of cold symptoms in mass gathering to Reducing the burden of disease

This is an unblinded factorial and cluster randomized clinical trial with four groups: Chaldanise, Lactogam, and Lactogam plus Chaldanise and control group. Randomization at the treatment center level was conducted using a sequence of simple random numbers generate by a computer. The trial is a phase 3 study and involves 2000 participants. This factorial study examines all possible scenarios that can be designed using two drugs.

We carried out a multicenter pragmatic unmasked cluster randomized factorial trial involving Iranian healthcare staff and members of therapeutic Mawkibs in Najaf, Karbala, and Mashaya.

The inclusion age range was 16 to 70 years old. Experience at least seven days working with patients in therapeutic conditions. Exclusion criteria: Immunodeficiency, Severe cardiovascular, endocrinological, respiratory, and gastrointestinal diseases, Pregnancy or lactation, Irritable bowel syndrome, active ulcerative colitis, or short bowel syndrome, Known hypersensitivity or allergy to any component of the test products, Severe deviation of the nasal septum, presence of nasal polyps, or other non-infectious conditions leading to nasal blockage, Recent treatment of the common cold that, in the opinion of the investigator, may influence symptoms.

We evaluated a lozenge that contains the strains Streptococcus salivarius K12 and M18 (Lactogum® lozenge) and a nasal spray that contains Carrageenan (Coldaniz Plus® nasal spray) to investigate their potential interaction in preventing gastrointestinal respiratory symptoms (GIRS) with control group.

effectiveness based on absence of flue-like symptoms when attending mass gatherings

Participants were randomly assigned to one of the four study groups using a computer-generated random number sequence. Cluster randomization was used at the clinic level to avoid contamination between participants. No stratification was performed, and the random sequence was generated using a statistical software program. Allocation concealment was ensured by keeping the random allocation sequence centrally until all participants were enrolled and baseline assessments were completed.

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The data can be used for statistical analysis and re-examination

Professor Mostafa Ghanei e-mail: mghaneister@gmail.com

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