Effect of Shiva modak granules in the management of under nutrition children

Phase 2/3

Not yet recruiting

Conditions: Unspecified protein-calorie malnutrition,

Registration Number: CTRI/2019/04/018470

Lead Sponsor: Department of Kaumarbhritya

Brief Summary: brief summary-

This study has been design to study the efficacy of this drug in the management of children in under nutrition . A shivamodak granule is palatable form of shiva modak. And the Hyderabad mix which is a cheap ad easily available dietary supplement proved to enhance growth and development in the process of nutritional rehabilitation.

background of trial -

In this study there are two groups in which group (A) the patient in the study will be given

shivamodak granule on empty stomach in the morning follow by

Hyderabad mix

to be prepared in milk for 8 weeks.

Now group (B) the patient in the control group will be given only Hyderabad mix

to be prepared in milk for 8 weeks.

and then assessment of the patient in both of the group will be assessed on the first day and subsequently in the interval of four week during the study and follow up for four weeks two week interval up to 12 weeks .

Findings-

shivmodak granule is effective in the management of under nutrition in children along with Hyderabad mix

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

subject with in age group 3 year to 6 year will be included in the study irrespective of sex,caste and religion.
subject with weight up to -2SD for the expected weight for age.

Exclusion Criteria

chronic malnutrition, secondary malnutrition, congenital disease,inborn errors of metabolism, kwashiorkor or any other systemic illness with organic causes, LBW babies whose catch up growth is not attend.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the nutritional status in children taking Hyderabad mix along with Shiva Modak granules.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in general well being of children taking Hyderabad mix along with Shiva Modak granules	12 weeks

Trial Locations

Locations (1): Parul Institute of Ayurved
🇮🇳
Vadodara, GUJARAT, India
Parul Institute of Ayurved
🇮🇳Vadodara, GUJARAT, India
Dipak Prakash Chaudhari
Principal investigator
9970048306
drdpc15@gmail.com