A Clinical Study to Evaluate the Efficacy of complementary Food in Respiratory Health and Overall Well being

Clinical Study to Evaluate the Efficacy of Complementary Food (Kidison) in Respiratory Health and Overall Well-being in Children- Randomized Open Label Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/07/055675

Enrollment

120

Registered

2023-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00- Acute nasopharyngitis [common cold]

Interventions

Intervention1: COMPLEMENTARY FOOD(KIDISON): Kidison with rich content of Amylase resistant starch is made with special care of properly selected ingredients like Rice flakes Essential pulses And Zinc

Eligibility

Inclusion criteria

Inclusion criteria: Both male and female children in the age group of 2 to 6 years Subjects who present with mild occasional cold, cough, sore throat, fever, heaviness of head or headache Loss of appetite rhinorrhea sneeze nasal congestion lethargy tiredness or fatigue Subjects or LAR willing to give written informed consent Subjects who are willing to maintain their regular diet pattern and refrain from taking any other beverages known to relieve cold& cough Subjects who have not participated in similar kind of study in last 4 weeks

Exclusion criteria

Exclusion criteria: Subjects with chronic obstructive respiratory disorders, gastrointestinal disorders Subjects who had undergone any surgery in the recent past Subjects with chronic upper or lower respiratory tract infection Subjects who are on any antibiotics anti allergic or anti inflammatory medications Subjects with established cardio pulmonary disorders hypertension renal or hepatic or cardiac failure Subjects with endocrine disorders Subjects currently using prescription medication to treat respiratory conditions Subjects who are not willing to sign informed consent form

Design outcomes

Primary

Measure	Time frame
Clinical improvement as assessed by clinical examination1 Reduction in frequency of URTI 2 Improvement in appetite 3 weight gain 4 reduction in antibiotic usage Assessment will be done on the scale of 0 to 3 0 is nil 1 is mild 2 is moderate 3 is severe The scoring will be in turn correlated with response to the treatment as follows Poor response less than 25 percent reduction Moderate response 25 to 49 percent Good response 50 to74 percent Excellent response 75 percentTimepoint: six & nine months	—

Measure

Time frame

Clinical improvement as assessed by clinical examination1 Reduction in frequency of URTI 2 Improvement in appetite 3 weight gain 4 reduction in antibiotic usage Assessment will be done on the scale of 0 to 3 0 is nil 1 is mild 2 is moderate 3 is severe The scoring will be in turn correlated with response to the treatment as follows Poor response less than 25 percent reduction Moderate response 25 to 49 percent Good response 50 to74 percent Excellent response 75 percentTimepoint: six & nine months

—

Secondary

Measure	Time frame
To assess the occurrence of any adverse To assess events & overall compliance of the subject to the study intervention Timepoint: six & nine months	—

Countries

India

Contacts

Public ContactK SURESH KUMAR

CHITTARANJAN SEVA SADAN & SISHU SADAN HOSPITAL

sudipsaha1973@gmail.com9831112705

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026