CTRI/2014/07/004756
Completed
Phase 2
A clinical study to evaluate efficacy and safety of Appetol syrup in children suffering from non-specific anorexia - NI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ARJUN HEALTHCARE
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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