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

Phase 4

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

Registration Number: CTRI/2023/07/055675

Lead Sponsor: Dr SUDIP SAHA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the occurrence of any adverse <br/ ><br>To assess events & overall compliance of the subject to the study intervention <br/ ><br>Timepoint: six & nine months