Clinical Study on Aptivate syrup in loss of appetite

Phase 3

Registration Number: CTRI/2024/08/071931

Lead Sponsor: upin Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Children diagnosed with Poor Appetite and Digestion without any underlying pathological condition without any significant weight loss over the last 3 months

2. Children having Eating Disorders falling in the criteria of - Unspecified Feeding or Eating Disorders as per DSM 5 TR criteria: (This category applies to presentations in which symptoms characteristic of a feeding and eating disorder that cause clinically significant distress or impairment in social, occupational, or other important areas of functioning predominate but do not meet the full criteria for any of the disorders in the feeding and eating disorders diagnostic class. The unspecified feeding or eating disorder category is used in situations in which the clinician chooses not to specify the reason that the criteria are not met for a specific feeding and eating disorder and includes presentations in which there is insufficient information to make a more specific diagnosis

Exclusion Criteria

1. Children with chronic illnesses and taking medications for the same or congenital abnormalities

2. Children who are currently taking any medications for appetite stimulation or digestive disorders

3. Children who have used any investigational product 1 month prior to screening in the present study

4. Children taking systemic antibiotics for any infection

5. Children with known metabolic and/or endocrine disorder/s

6. Children with any type of known GI tract disorder (including mal-absorption syndrome, etc.)

7. Children with known Liver and Renal disorders

8. Children with known immunological, hematologic disorders, neurological or

psychiatric pathologies

9. Children with known hypersensitivity to herbal ingredients used in the study product or in general to any herbal product

10. Any other condition due to which children are deemed to be unsuitable by investigator for reason(s) not specifically stated in the exclusion criteria