A clinical of Appetol syrup in children suffering from non-specific anorexia (loss of appetite)
- Conditions
- Health Condition 1: null- non-specific anorexia
- Registration Number
- CTRI/2014/07/004756
- Lead Sponsor
- ARJUN HEALTHCARE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1 Weight and BMI <br/ ><br>2 Activity level on PAQ-C Scale <br/ ><br>3 Abdominal pain abdominal distension, flatulence, constipation, nausea, vomiting <br/ ><br>4 Overall improvement by Physician and Patientâ??s LAR at the end of the study. <br/ ><br>5 Acceptability of drug <br/ ><br>6 Drowsiness or sedation <br/ ><br>7 Adverse events <br/ ><br>8 Drug tolerability by patients LAR and physician at the end of the study <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 0 day 15 day 30 day 45 day and 60 day