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Clinical Trials/CTRI/2021/09/036251
CTRI/2021/09/036251Not yet recruitingPhase 4

A Clinical Study to Evaluate the Effect of Karshyahar Yoga Granules and Ksheer Bala Tail Matra Basti in Karshya w.s.r to Under Nutrition in Children

Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital1 site in 1 country40 target enrollmentStarted: September 18, 2021Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Improvement in weight gain according to age

Study Overview

Brief Summary

Nutrition is one critical factor which modulates the immune response, thus playing a crucial role in determining the outcome of an infectious illness. Further, morbidity and mortality dur to infectious illness are high among certain risk populations like low bith weight infants and malnourished children. in comparision to adult the nutrient requirement of children are 2-3 times higher because of their additional needs for growth. In India  majority of children have weighs below the 50th percentile of NCHS standards. Underweight is defined as low weight for age and it is combined indicator to reflect both acute and chronic malnutrition. The condition can be correlated with karshya. Karshya being the Vata Pradhan Vyadhi, chikitsa  like Brihmana, Rasayana, have been advocated in the classics for its management. Brimhana therapy is indicated in krishata to increase bulk of body.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Open Label

Eligibility Criteria

Ages
2.00 Year(s) to 16.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient between 2-16 yrs of age irrespective of sex with poor weight gain, lean and thin body as per IAP ( grade 1 and grade 2).
  • patient fulfilling the description of karshya described in our texts like sushka-sphika, sushka-udara, sushka-griva, Dhamani-jala darshanam.

Exclusion Criteria

  • patient suffering from severe malnutrition (grade3 and grade 4) children with congenital anomaly.
  • children with chronic ailments like tuberculosis, malignancy, cardiac and renal problems.
  • children suffering from UTI, Diabetes mellitus and having physical disability.

Outcomes

Primary Outcomes

Improvement in weight gain according to age

Time Frame: Day 1, Day28, Day 56, Day91

Secondary Outcomes

  • improvement in symptoms of Karshya like sushka sphika-udara-griva, dhamni jala darshanm(Day1, Day 28, Day 56, Day91)

Investigators

Sponsor
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital
Sponsor Class
Government medical college

Study Sites (1)

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