None listed
Conditions
Interventions
None listed
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the clinical symptoms of anorexia measured using the total effective rate (TER). 2. Change in eating behavior using Child Eating Behavior Questionnaire (CEBQ) Timepoint: Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in appetite assessed using VAS 2. Change in appetite assessed using picture based appetite assessment tool 3. Change in desire to eat, quantity of food intake, left over in the plate, number of meals taken per day and range of food taken on VAS 4. Change in anthropometric measurements 5. Change in abdominal pain, bowel habits, abdominal fullness, flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels and physical activity using VAS. 6. Assessment of overall sensorial feeling 7. Assessment of drowsiness or sedation 8. Change in memory on Children Memory Questionnaire 9. Change in incidence of infections, and allergy related disorders 10. Change in onset of action and duration of action of drugs with respect to its appetite stimulating activity. 11. Global assessment of overall change to be assessed by Physician and Subject 12. Assessment of adverse eventsTimepoint: Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed