Effect of Ayush BR Leham in addition to Supplementary Nutrition Programme in undernourished children studying in Anganwadi centres

Efficacy, Safety, and Acceptability of Ayush BR Leham as an Adjuvant to the Supplementary Nutrition Programme under ICDS in the Management of Moderate Malnutrition among Children aged 3- 5 years from Anganwadi centres - A cluster randomized controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070323

Enrollment

100

Registered

2024-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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. Age group between 3-5 years of either sex 2. Weight-for-Height Z scores =-2 SD and = -3 SD of the median as per WHO Child Growth Standards 3. Absence of Edema 4. Studying in Anganwadi Centre run by ICDS 5. Will not share medication with others 6. Parents/guardians willing to provide a written informed consent form for the participation of their children.

Exclusion criteria

Exclusion criteria: 1. Presenting with acute infections e.g. Acute respiratory tract infection, diarrhea, etc. (Temporary Exclusion) 2. Weight for Height Z score less than -3 SD of the median as per WHO Child Growth Standards 3. Presence of edema 4. On any medication for the last two months except vitamins and Minerals. 5. Underlying chronic diseases that may affect growth (cardiac, renal, tuberculosis, liver disease, HIV/AIDS) 6. Child with neurological and hereditary disease 7. Child with congenital abnormalities 8. Any other condition that the Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
The proportion of participants attaining a change in Weight for Height Z score (WHZ)more than or equal to - 1 SD as per WHO Child Growth Standards.Timepoint: Time frame – at the baseline, 4th Week, 8th Week, 12th week	—

Secondary

Measure	Time frame
1. Improvement in weight for Age Z score, height for age Z score, Head circumference for age Z score, BMI for age Z score, Mid Upper Arm circumference for age Z score, Triceps Skin Fold thickness for age Z score, Subscapular Skinfold for age Z score) 2. Incidence / Prevalence of ARI, diarrhea, and fever during the treatment period 3. Acceptability of the Intervention drug 4. Improvement in Quality of life by Assessing the Pediatric Quality of Life Inventory (PedsQoL) – parent version 5. Improvement in Cognitive functioning – Assessed by Seguin Form Board Test 6. Safety -Reporting of Incidence of AEs/SAEs and Laboratory investigationsTimepoint: 1. Time frame – at the baseline, 4th Week, 8th Week, 12th week 2. Time frame – at the baseline, 4th Week, 8th Week, 12th week 3. Time frame – 12th week 4. Time frame – At baseline and 12th week 5. Time frame – Baseline and 12th week 6.1. Reporting of Incidence of AEs/SAEs at each scheduled visit 6.2 Laboratory Investigations - At baseline and 12th Week (Subject to consent provided by parents/guardian)	—

Measure

Time frame

1. Improvement in weight for Age Z score, height for age Z score, Head circumference for age Z score, BMI for age Z score, Mid Upper Arm circumference for age Z score, Triceps Skin Fold thickness for age Z score, Subscapular Skinfold for age Z score) 2. Incidence / Prevalence of ARI, diarrhea, and fever during the treatment period 3. Acceptability of the Intervention drug 4. Improvement in Quality of life by Assessing the Pediatric Quality of Life Inventory (PedsQoL) – parent version 5. Improvement in Cognitive functioning – Assessed by Seguin Form Board Test 6. Safety -Reporting of Incidence of AEs/SAEs and Laboratory investigationsTimepoint: 1. Time frame – at the baseline, 4th Week, 8th Week, 12th week 2. Time frame – at the baseline, 4th Week, 8th Week, 12th week 3. Time frame – 12th week 4. Time frame – At baseline and 12th week 5. Time frame – Baseline and 12th week 6.1. Reporting of Incidence of AEs/SAEs at each scheduled visit 6.2 Laboratory Investigations - At baseline and 12th Week (Subject to consent provided by parents/guardian)

—

Countries

India

Contacts

Public ContactDr Kuldeep Choudhary

Central Council for Research in Ayurvedic Sciences

kuldeepall@yahoo.co.in8198865710

Outcome results