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Clinical Trials/CTRI/2022/11/047787
CTRI/2022/11/047787Not yet recruitingPhase 2/3

A Randomised standard controlled clinical trial to assess the efficacy of Duralabhadi Arka in management of chhardi in ksheerapavastha (infantile age)

PDEAs College of Ayurved and Research centre Nigdi Pune1 site in 1 country60 target enrollmentStarted: January 12, 2022Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Relief in vomiting episode

Study Overview

Brief Summary

Chhardi is a common symptoms in paediatric practice through it can occur in any age group chhardi is a vyadhi of annavaha strotas described separately by different acharya as in ayurveda.there are various causes of vomiting described as per age from infection of various systems to anatomical defects of gastrointestinal system .in infantile age regurgitation of feed due to aerophagy and increased gastrointestinal system .in infantile age regurgitation of feed due to aerophagy and gastrocolic reflex are the main cause of vomiting .in present study ksheerapavastha chhardi has been taken with modern correlation with regurgitation of feed and gastroesophageal reflux disease of infancy . through this is a benign condition but it bothersome parents as modern like domperidone and ondensetron used just to relief in vomiting and discontinuation problem come again.dugdhvaman is very common in ksheerapavastha .it can be correlated with regurgitation of feed and GERD .ayurveda provide many herb act as vatanulomak along with chhardi nigrahan nigrahan properties can provide long term relief alog with proper feeding technique as vomiting associated with belching in many infants .in search of safe and effective drug Duralabhadi Arka yog described in sahastrayogam for chhardi which contains Ella ,twak ,tejpatra and duralabha having properties like vatanuloman ,deepan ,pachan ,vathar , grahi mentioned in bhavprakash has been chosen for the study to check the efficacy of this yog in ksheerapavastha chhardi .

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
0.00 Day(s) to 12.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • 1 ksheerap shishu having sign and Symptom as mentioned in ayurvedic texts chhardi ( 2 or more episodes) with 2 or more symptoms stanyadvesh , vibandh, urdhwavata, hikka.
  • 2 selection will be irrespective of sex religion and socio economic class, age between 0-12 months.

Exclusion Criteria

  • 1 infant having vomiting associated with fever 2 vomiting associated with any infection of gastrointestinal tract eg gastroenteritis , respiratory system like pneumonia , urinary tract infection , central nervous system ( meningitis) 3 patients having dehydration associated with vomiting 4 known case of any anatomical defects of gastrointestinal tract 5 known case of endocrine disorder like hyperthyroidism 6 suspected patient of covid 19.

Outcomes

Primary Outcomes

Relief in vomiting episode

Time Frame: Total 3 days treatment follow up on 2nd and 3 rd day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
PDEAs College of Ayurved and Research centre Nigdi Pune
Sponsor Class
Private medical college

Study Sites (1)

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