NUTRITIONAL INTERVENTION OF SHALI GODHUMADI PRASHA IN UNDERWEIGHT PRESCHOOL PARTICIPANTS WITH WEIGHT GAIN AS PRIMARY OUCOME.

A Randomized Open Label Controlled Trial To Evaluate The Efficacy of Shali Godhumadi Prasha And Hyderabad Mix in Underweight Children of Pre-school age with Special Reference to Karshya.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104887

Enrollment

Registered

2026-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: E440- Moderate protein-calorie malnutrition

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects of either gender between the ages of 3 to 5 years. 2.Subjects with weight less than expected for their age i.e Grade 1 and Grade 2 Malnutrition. According to IAP classification. 3.Subjects presenting with two or more symptoms of Karshya Like Shushka Spik, shushka Guda, 4.Shushka Greeva, Dhamani jalasantata, Twak Shosha, Ashti shosha and Sthula Parvana.

Exclusion criteria

Exclusion criteria: 1.Subjects with acute or chronic systemic illnesses or those requiring emergency management. 2.Subjects with infectious diseases, systemic disorders, or malignancies. 3.Subjects with developmental disorders such as cerebral palsy or intellectual disability. 4.Subjects with inborn errors of metabolism or congenital abnormalities. 5.Subjects with neurobehavioral disorders such as ADHD or Autism.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of Shali Godhumadi Prasha in the management of underweight pre school children, on anthropometric paramerters like weight, height, mid arm circumference, chest circumference and graded clinical features of karshya.Timepoint: within 2 years	—

Secondary

Measure	Time frame
1.To prepare and standardize the Shali Godhumadi Prasha. Organoleptic analysis - color, shape, odour, taste . Analytical analysis - Bulk density, pH, Determination of moisture content. 2.To study the nutritional properties of Shali Godhumadi Prasha. Proximate composition : Energy value, Carbohydrate, protein, fat . 3.To assess the quality of life in malnourished child using TNO AZL scale pre school children s quality of life. 4.To compare the efficacy of Shali Godhumadi Prasha and Hyderabad Mix in management of underweight children of pre school age with special reference to Karshya.Timepoint: within 2 years	—

Measure

Time frame

1.To prepare and standardize the Shali Godhumadi Prasha. Organoleptic analysis - color, shape, odour, taste . Analytical analysis - Bulk density, pH, Determination of moisture content. 2.To study the nutritional properties of Shali Godhumadi Prasha. Proximate composition : Energy value, Carbohydrate, protein, fat . 3.To assess the quality of life in malnourished child using TNO AZL scale pre school children s quality of life. 4.To compare the efficacy of Shali Godhumadi Prasha and Hyderabad Mix in management of underweight children of pre school age with special reference to Karshya.Timepoint: within 2 years

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Countries

India

Contacts

Public ContactDr Chithralekha

SDM Collage of Ayurveda, hospital and Research Centre Kuthpady udupi.

chithra.5111991@gmail.com9535031157

Outcome results