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Clinical Trials/CTRI/2023/07/054916
CTRI/2023/07/054916Not yet recruitingPhase 3

A Comparitive Clinical Study To Assess The Effect Of Yashtimadhusadhit Ghrita and Ashwagandha Ghrita in Karshya w.s.r to Underweight in Children

Dr Ashwarya Gaur1 site in 1 country60 target enrollmentStarted: July 14, 2023Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Relief From Subjective Assessment Criteria i.e Daurbalya, Kshudha, Dhamani jala darshana, Sthula Parva .

Study Overview

Brief Summary

TITLEOF DISSERTATION

"A COMPARITIVECLINICAL STUDY TO ASSESS THE EFFECT OF YASHTIMADHUSADHIT GHRITA AND ASHWAGANDHAGHRITA IN KARSHYA         W.S.R TOUNDERWEIGHT IN CHILDREN."

AIM AND OBJECTIVE

AIM-

To compare the clinical efficacy of Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita

in management of Karshya in children.

OBJECTIVE-

  1. To review the literature of Karshya in children.

  2. To study the mode of action of Yashtimadhu Sadhita Ghrita on Karshya in children.

  3. To study the mode of action of Ashwagandha Ghrita on Karshya in children.

  4. To compare the effect of Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita in

Karshya in children.

RESEARCH QUESTION

PRIMARY RESEARCH QUESTION :

Does Yashtimadhu Sadhita Ghrita and Ashwangandha Ghrita have significant difference

in the effect on karshya in children.

HYPOTHESIS

  1. NULL HYPOTHESIS(H0)-

There will be no significant difference in the effect on Karshya in children by the

intervention of Yashtimadhu Sadhita Ghrita & Ashwagandha Ghrita.

  1. ALTERNATIVE HYPOTHESIS(H1)-

There will be significant difference in effect on Karshya in children by intervention of

Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita.

ASSESSMENT CRITERIA

SUBJECTIVE PARAMETERS:

1 DAURBALYA

2 KSHUDHA

3DHAMNI JALA DARSHANA

4 STHULA PARVA

OBJECTIVE PARAMETER

1 WEIGHT

2 HEIGHT

3 CHEST CIRCUMFERENCE

4 ABDOMINAL GIRTH

5 MID ARM CIRCUMFERENCE

MATERIAL (GROUP A)

YASHTIMADHUSADHIT GHRITA

Yashtimadhu, Padmaka, Taleesh, Pippali, Utpala, Lodhra, Chandana, Sariva, Goghrita

Dose- 2 to 7 ml according to weight

(GROUP B)

ASHWAGANDHAGHRITA

Ashwagandha and Goghrita

Dose- 2 to 7 ml according to weight

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
3.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1: Childern Age Group Between 3-8 years.
  • 2: Childern Between (-2 TO -3 SD) Weight For Age According To WHO.

Exclusion Criteria

  • 1: Known Case Of Systemic Disorders 2: Childern <-3 SD (Standard Deviation ) and >-2 SD Weight foe Age According TO WHO.

Outcomes

Primary Outcomes

Relief From Subjective Assessment Criteria i.e Daurbalya, Kshudha, Dhamani jala darshana, Sthula Parva .

Time Frame: Baseline & after every 15 day for 2 Months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Ashwarya Gaur
Sponsor Class
Other [Other (self)]

Study Sites (1)

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