| CTRI Number |
CTRI/2022/11/047787 [Registered on: 30/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between Duralabhadi Arka Domperidone Drops in management of vomiting in infantile age ( upto 1 yr) |
|
Scientific Title of Study
|
A Randomised standard controlled clinical trial to assess the efficacy of Duralabhadi Arka in management of chhardi in ksheerapavastha (infantile age) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kishor Shivaji Bhone |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Third floor Kaumarbhritya department sector no 25 Nigdi Pradhikaran Pune MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
7875579881 |
| Fax |
|
| Email |
bhonekishor22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Third floor Kaumarbhritya department sector no 25 Nigdi Pradhikaran Pune MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishor Shivaji Bhone |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Third floor Kaumarbhritya department sector no 25 Nigdi Pradhikaran Pune MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
7875579881 |
| Fax |
|
| Email |
bhonekishor22@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research centre Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research centre sector no 25 Pradhikaran Nigdi Pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kishor Shivaji Bhone |
Ayurved Rugnalay and sterling multi-speciality hospital Nigdi Pradhikaran Pune |
Vitthal Rukhmini road sector 27 Kaumarbhritya OPD no 118 nigdi pradhikaran pune 411044 Maharashtra pune
Pune
MAHARASHTRA |
7875579881
bhonekishor22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female infant with chhardi in ksheerapavastha |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Domperidone drops | Domperidone Dose – 0.2-0.4mg/kg/dose q 4-8hrs1 |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in vomiting episode |
Total 3 days treatment follow up on 2nd and 3 rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 . |