Study on Effectiveness of Kushmandak Rasayana (An Ayurvedic Medicine) in Improving Nutrition in Moderately Malnourished Children Aged 4-9 Years

Effectiveness of Kushmandak Rasayana in the Management of Moderately Malnourished Children Aged 4-9 Years - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084372

Enrollment

540

Registered

2025-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E41- Nutritional marasmus

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Children with weight for age z score between -2 SD and +3SD of the World Health Organization (WHO) weight for age growth standards i. Children of either sex; age group between 4-9 years ii. Children with weight-for-age between -2 SD and -3 SD of the World Health Organization (WHO) weight for age growth standards. iii. Parents or caregivers willing to provide a written informed consent form for the participation of their children.

Exclusion criteria

Exclusion criteria: i. Children with Sever Acute Malnutrition ii. Children with known case of Sickle Cell Disease (only SS pattern) iii. Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery iv. Children with acute infections viz- respiratory tract infections, diarrhea, fever etc v. H/o hypersensitivity to the trial drug or any of its ingredients. vi. Patients who have completed participation in any other clinical trial during the past six months. vii. Any other condition which the Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
i.Change in weight for age Z score by using WHO child growth standardsTimepoint: Baseline, end of 3rd month, end of 6th month	—

Secondary

Measure	Time frame
i. Changes in the score of PedsQL inventoryTimepoint: Baseline, end of 3rd month and end of 6th month;ii. Incidence of treatment Emergent Adverse EventsTimepoint: Every Visit;iii. Assessment of the tolerability of Kushmandak Ramayana (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study periodTimepoint: every Visit;iv. Assessment of treatment adherence through participant self-reported compliance log and used medication containersTimepoint: 30th day visit, 60th Day visit, 90th Day visit, 120th Day and 180th Day visit;v. Change in the laboratory parameters from baseline (Complete Blood Count, Liver Function Test, Kidney Function Test)Timepoint: baseline, and 180th Day	—

Measure

Time frame

i. Changes in the score of PedsQL inventoryTimepoint: Baseline, end of 3rd month and end of 6th month;ii. Incidence of treatment Emergent Adverse EventsTimepoint: Every Visit;iii. Assessment of the tolerability of Kushmandak Ramayana (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study periodTimepoint: every Visit;iv. Assessment of treatment adherence through participant self-reported compliance log and used medication containersTimepoint: 30th day visit, 60th Day visit, 90th Day visit, 120th Day and 180th Day visit;v. Change in the laboratory parameters from baseline (Complete Blood Count, Liver Function Test, Kidney Function Test)Timepoint: baseline, and 180th Day

—

Countries

India

Contacts

Public ContactVd Jaiprakash Ram

Central Council for Research in Ayurvedic Sciences (CCRAS)

drprashantccras@yahoo.com9623011214

Outcome results