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Evaluation of The efficacy and safety of Dabur Appetizer Syrup in Children

Evaluation of Efficacy and safety of DRF/AY/4008 as an appetite stimulant in children with non-pathogenic Anorexia

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006465
Enrollment
100
Registered
2015-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: Dabur Appetizer Syrup.: 5 ml twice daily orally and treatment period was 45 days. Control Intervention1: Placebo - sugar Base syrup: 5 ml twice daily orally and treatment period was 45

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age-group 3 to 12 years. 2. History of poor appetite with or without reduced food intake. 3. Ready to provide informed consent and to come for regular follow-up evaluation as and when required. 4. Subjects were administered a single dose of PO Albendazole 400 mg, one week before the enrollment.

Exclusion criteria

Exclusion criteria: 1.Subjects with compromised renal and liver function. 2. Subjects with any chronic infection or significant systemic disease. 3. Subjects with known history of food allergies. 4. Subjects with inflammatory conditions of oral cavity i.e. ulcers, or neuromuscular dysfunction affecting swallowing. 5. Subjects not willing to sign informed consent 6. Subjects not willing to come for follow-up as and when required

Design outcomes

Primary

MeasureTime frame
Rating for various appetite related factors like hunger rating, rating for fullness and satiety, fatigue and general energy levels, on a visual analogue scaleTimepoint: 45 days

Secondary

MeasureTime frame
Anthropometric evaluation for selected growth parameters were recorded on visit 0, 15, 30 and 45 days.Timepoint: 45 days

Countries

India

Contacts

Public ContactDr Sasi Bhushan

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026