Health Condition 1: null- non-specific anorexia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 The informed consent document must be read signed and dated by subjects legally authorized representative before conducting any study procedures or examination 2 Males and females between 5 to 9 years of age 3.Subjects suffering from non specific anorexia 4.Subjects having normal vital parameters
Exclusion criteria
Exclusion criteria: 1 Children with SNAQ score less than or equal to 14 2 Children with chronic illnesses congenital abnormalities 3 Subject who is on other appetite stimulants sedatives narcotics and steroidal drugs 4 Subjects who have received treatment another investigational agent within last thirty days from Screening Visit 5 Subjects who have received chemotherapy or radiation therapy within the past 5 years 6 Subjects on systemic antibiotics or systemic therapy with cytotoxic drugs 7 Subjects having metabolic and or endocrine disorders 8 Subjects with any type of GI tract disorder including malabsorption syndrome etc 9 Subjects with liver and renal disorders 10 Subjects with known immunological, hematologic disorders or malignancy 11 Subjects having known neurological or psychiatric pathologies 12 Subjects with history of raised levels of cortisol abnormalities of thyroid hormone growth hormone and insulin secretion 13 Subject or LAR refuse to sign informed consent form 14 Subjects having a known hypersensitivity to Appetol Syrup and any of the ingredients of Appetol Syrup
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Appetol syrup in children suffering from non-specific anorexia by assessing SNAQ ScaleTimepoint: 0 day 15 day 30 day 45 day and 60 day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Weight and BMI 2 Activity level on PAQ-C Scale 3 Abdominal pain abdominal distension, flatulence, constipation, nausea, vomiting 4 Overall improvement by Physician and Patientâ??s LAR at the end of the study. 5 Acceptability of drug 6 Drowsiness or sedation 7 Adverse events 8 Drug tolerability by patients LAR and physician at the end of the study Timepoint: 0 day 15 day 30 day 45 day and 60 day | — |
Countries
India
Contacts
ARJUN HEALTHCARE