A Clinical trial to study the effect of Amritapraasha Ghrita in children with under nutrition
- Conditions
- Unspecified protein-calorie malnutrition,
- Registration Number
- CTRI/2017/11/010536
- Lead Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
- Brief Summary
This study is an open label, two arm, randomized, active controlled clinical trial comparing the efficacy of Amritapraasha Ghrita 6ml twice daily and normal home based diet(no intervention) in 30 patients of the age group 3-5yrs with grade 1 and 2 under nutrition. 6ml of Amritapraasha Ghrita wil be given twice daily with milk for 42 days for the study group and will be followed up after two weeks.This study will be conducted in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India. The primary outcome measures will be increase in weight in kg(IAP Grading of malnutrition), height in cm, head circumference in cm, chest circumference in cm, mid arm circumference in cm and skin fold thickness. The secondary outcome measures will be relief from dourbalya
(general weakness), increase in kshudha(appetite), increase of interest in activity, attaining sound nidra (sleep), improvement in appearance, relief from constipation, increased buccal pad of fat, improved academic performance and improved laboratory parameters. the laboratory parameters are CBC, Hb% and serum protein. The data will be tabulated and analyzed using SPSS softwere by using appropriate statistical test like Friedman’s test, Wilcoxon’s signed rank test, chi-square test, repeated measure ANOVA, paired t and unpaired t test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Subjects within age group 3-5years will be included in the study irrespective of gender, caste & religion.
- Weight for age to be between 60 – 80 %.
- Those parents who are ready to sign informed assent form.
Patient associated with acute and chronic infections, Mal-absorption syndrome and inborn errors of metabolism will be excluded from the trial based on clinical presentations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. Improvement in Kshudha(appetite), Interest in activity, Nidra (Sleep), Appearance. 56 days (General weakness) 56 days 4. Improved Buccal pad of fat 56 days 1. Relief from Dourbalya 56 days 3.Relief from constipation, 56 days 5. Improved academic performance 56 days
- Secondary Outcome Measures
Name Time Method 1. Improvements in height in cm (measured using stadiometer) 2. Improvements in weight in kg (measured using standard weighing scale)
Trial Locations
- Locations (1)
out patient department, room number 2, department of kaumarabhritya.
🇮🇳Hassan, KARNATAKA, India
out patient department, room number 2, department of kaumarabhritya.🇮🇳Hassan, KARNATAKA, IndiaDr Saranya SivarajPrincipal investigator9620088483shalupinksss@gmail.com