A study to compare efficacy of Nutri Leha as against Ready to Use Therapeutic Food in Karshya Severe Acute Malnutrition in children

Phase 3

Not yet recruiting

• Conditions: Unspecified severe protein-caloriemalnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA),

• Registration Number: CTRI/2023/11/059755
• Lead Sponsor: Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha

Brief Summary

The volunteers will be informed about the study protocol . Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated.

Prior to study approval will be taken From IEC,MGAHRC, Salod, Wardhaand CTRI registration will be done. After selection, each participant will  be tested and selected according to the selection criteria. They are divided into two groups the trial is a  two arm parallel group, randomized, open labelled, clinical standard controlled trial. It will include a 90 days  treatment period with assessment on 15th , 30th, 45th, 60th, 75th, 90th day of treatment and follow up on 30th, 60th and 90th day post treatment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-11
• Study Start: 2023-11-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patient suffering from karshya Children having low weight for height below -3 SD low BMI for age and children falling in grade 3 and 4 classification of PEM according to IAP.

Exclusion Criteria

Children having low weight for height below -3 SD low BMI for age and children falling in grade 1 and 2 classification of PEM according to IAP Below 6 month and above 5 years suffering from infectious diseases like TB HIV etc Suffering from complicated severe acute malnutrition Guardian who are not willing to give informed written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Nutri Leha and Ready to Use Therapeutic Food in reducing clinical features of Karshya	90 days

Secondary Outcome Measures

Name	Time	Method
Comparison & assessment of efficacy of Nutri Leha & Ready to Use Therapeutic Food on anthropometric values	3 months

Trial Locations

Locations (1)

Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha

🇮🇳Wardha, MAHARASHTRA, India

Dr Klita Pereira

Principal investigator

09967902890

klitapereira02@gmail.com