Studying the effect of Herbal Drug Entitled Baby Colic Included Melissa Officinalis, Foeniculum Vulgare, Matricaria Chamomilla and Zingiber Officinale on Infant Colic and Comparing it with Gripe Water

Investigating the effect of the combination of chamomile, fennel, ginger and lemon balm in the treatment of infants with infantile colic

This study will be a randomized, double-blind, parallel clinical trial. Randomization was performed using the permuted block randomization method based on the Rand function in Excel. After entering and completing the informed consent form, participants were placed in two treatment groups of 32 people.

Infants with neonatal colic referred to a neonatologist clinic in Kashan will be included in the study based on Rome III criteria. Treatment will be given to individuals for 7 days. The primary outcome of the study is the duration of daily crying. Secondary outcomes include improvement after 3 and 7 days of treatment. Infants who experience a 50% reduction in daily crying compared to the start of treatment will be considered responders to the treatment. Feeding schedule, stool frequency and characteristics, and any adverse events will be observed and recorded.

Inclusion criteria: Every baby aged 3 to 16 weeks who has been diagnosed with infantile colic according to the Rome III criteria. Exclusion criteria: Intense or loud crying; Symptoms after 4 months of age; Failure to thrive; Developmental delay; Maternal drug use; Fever or illness; Parental anxiety or maternal depression; Abnormal physical examination; Bloody stool; Vomiting; Serious complications and illness.

Baby Colic Syrup: Containing extracts of chamomile, fennel, ginger and lemon balm. Made by Barij Essence Pharmaceutical Company Gripe water Syrup: Containing extracts of cumin and dill. Made by Dineh Pharmaceutical Company

ِDuration of crying; times of crying per day; Stomach ache; Cramps; Mother's opinion about recovery; drug side effects

Randomization is done by blocked method (Permuted block randomization) so that first all 4 blocks containing two codes A and B are prepared (6 blocks) then random blocks are selected by placement using a table of random numbers. These blocks form a sample-sized sequence of A and B codes, each of which is randomly assigned to one of the groups. The list of relevant codes will remain in the formulation section until the completion of the design. With this method, both blinding and randomization will be provided.

In order to characterize the characteristics, an independent statistician, blind to the enrolled patients, will design and maintain a computerized two-treatment randomization program with diagnosis blocks of different scales to maintain composition in the allocation of participants between treatment groups. Randomization will be stratified by type of infant feeding (exclusively breastfed or formula fed) and age. At each enrollment, the statistician, who is the only person with access to the randomization program, the drug prescribed will inform the principal investigator and the ITT analysis and analysis, missing data will be imputed using the multiple imputation method. .

Because the drug company does not want to release the data

As mentioned, I have no plans to publish the study data

After June 23, 2026

Researchers and students who want to use this data to learning statistical analysis

Learning and research

Kashan University of Medical Sciences, Department of Biostatistics and Epidemiology

It is given as a written request to the secretary of the department. The request is sent to the director of the department and after approval it is sent to the researcher.