Study on Moderate malnutrition in children aged 3-5 years

Evaluation of the efficacy of Ayush-BR Leham in the management of Moderate malnutrition among children aged 3-5 years â?? A Multicenter Randomized Controlled Pilot study trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055188

Enrollment

200

Registered

2023-07-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: E440- Moderate protein-calorie malnutrition

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of age group between 3-5 years 2. Children with weight for age between -2 and -3 SD of the World Health Organization weight for age growth standards 3. Children without the presence of edema 4. Parents or caregivers willing to provide a written informed consent form for the participation of their children

Exclusion criteria

Exclusion criteria: 1. Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery 2. Children with acute infections viz- respiratory tract infections, diarrhoea, fever etc 3. History of hypersensitivity to the trial drug or any of its ingredients 4. Patients who have completed participation in any other clinical trial during the past six months 5. Any other condition which the Investigator thinks may jeopardize the study

Design outcomes

Primary

Measure	Time frame
Proportion of participants attaining a change in weight for age z score by 0.5 or more as per WHO reference standardsTimepoint: Time frame 16 weeks assessment at baseline & 12th week followed by assessment at 16th week	—

Secondary

Measure	Time frame
Change in the frequency of illnessesTimepoint: Time frame 16 weeks â?? assessment at the baseline, 12th week & 16th week;Changes in the anthropometric measurements (weight, height, BMI, mid upper arm circumference)Timepoint: Time frame 16 weeks â?? assessment at baseline, every 2 weeks in the first 12 weeks followed by assessment at 16th week;Safety parameters assessed on the basis of biochemical parametersTimepoint: Time frame 12 weeks â?? assessment at the baseline, 12th week	—

Measure

Time frame

Change in the frequency of illnessesTimepoint: Time frame 16 weeks â?? assessment at the baseline, 12th week & 16th week;Changes in the anthropometric measurements (weight, height, BMI, mid upper arm circumference)Timepoint: Time frame 16 weeks â?? assessment at baseline, every 2 weeks in the first 12 weeks followed by assessment at 16th week;Safety parameters assessed on the basis of biochemical parametersTimepoint: Time frame 12 weeks â?? assessment at the baseline, 12th week

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Countries

India

Contacts

Public ContactDr Karthika A P

National Ayurveda Research Institute for Panchakarma

drkarthikaap@gmail.com9446502709

Outcome results