Effect of Ayurveda drug, Krishnadi granules in management of Protein Energy Malnutrition in preschool childre

Phase 3

Completed

• Conditions: Health Condition 1: E440- Moderate protein-calorie malnutrition

• Registration Number: CTRI/2021/01/030309
• Lead Sponsor: Dr Sumod Khedekar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-27
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Age group between 3 years to 6 years of age suffering from Karshya with irrespective of prakruti, desha, kala, bala, and socio-economic status.

2. Children having Weight for height Z score ââ?°Â¥ âË?â??2 SD to âË?â??3 SD of the WHO standards (MAM and Uncomplicated SAM)-70-79 % of expected weight will be enrolled for study.

3. Children having classical symptoms of Karshya, mentioned in Ayurveda texts like shushka Shroni, Udara and Greeva (emaciated buttocks, abdomen and neck) etc. PEM gradation as per IAP-1 to 3, midarm circumference below 13.5cm to 11.5 cm as per Shakirââ?¬•s tape (uncomplicated PEM cases)

Exclusion Criteria

1. Children suffering from infectious diseases like Tuberculosis, HIV and other major systemic disorders.

2.Diagnosed cases of Hyperthyroidism, mal-absorption syndrome like Irritable Bowel

Syndrome, metabolic disorders, gastro intestinal tract disorders, congenital heart disease, Low

birth weight, pre mature babies.

3. Children having Hb% below 8gm %.

4. If the child is Complicated SAM or Normal for weight.

5. Child below 24 months of age and more than 72 months of age.

6. Children / Guardian who are not ready to give informed /written consent for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cardinal features of Karshya/PEM along with weight gain (10%) due to Brumhana effect of Krishnadi granules as an adjuvant along with ICDS guidelines in intervention group as compared to the control group.Timepoint: At Baseline, 15th Day, 30th Day, 45th Day, 60th Day.

Secondary Outcome Measures

Name	Time	Method
a)Improvement in Laboratory parameters such as Serum protein values, Transferrin, Pre-albumin. <br/ ><br>b)Improvement in other Anthropometric Parameters <br/ ><br>c)Improvement in morbidity specifically, time to recovery, prevalence of diarrhea, acute lower respiratory tract infection (ALRI) and hospitalizations during the treatment phase.Timepoint: At Baseline, 15th Day, 30th Day, 45th Day, 60th Day.