| CTRI Number |
CTRI/2024/07/069949 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of dhatrirasadiprayog in the management of vomiting in school going children |
|
Scientific Title of Study
|
Open randomized controlled clinical study on the efficasy of dhatrirasadiprayog in the management of chhardi in children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parag Dattakumar Nanaware |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta |
| Address |
Dhanvantari Ayurved Hospital Ashta Balrog OPD Room no 10 Ground Floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
8856986819 |
| Fax |
|
| Email |
paragnanaware79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nareshkumar Babar |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta |
| Address |
3rd Floor Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507595454 |
| Fax |
|
| Email |
dr.nareshbabar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nareshkumar Babar |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta |
| Address |
3rd Floor Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507595454 |
| Fax |
|
| Email |
dr.nareshbabar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Gaduate And Research Center Ashta Tal Walwa Dist sangali Maharashtra 416301 india |
|
|
Primary Sponsor
|
| Name |
Dr Parag Dattakumar Nanaware |
| Address |
OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Maharashtra 416301 india |
| Type of Sponsor |
Other [Self] |
|
|
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 Parag Dattakumar Nanaware |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
Dhanvantari Ayurved Hospital Ashta Balrog OPD Room No 10 Ground Floor
Sangli
MAHARASHTRA |
8856986819
paragnanaware79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki Churna, Reference: Bhaishjyaratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.8(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatrirasadiprayog, Reference: Chakradatta, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 14.4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 vomiting due to Indigestion over eating and excessive intake of liquid diet
2 Vomiting due to incompatible spicy diet
3 vomiting due to fried food dried food packed and tinned food |
|
| ExclusionCriteria |
| Details |
1 Patients of Sannipataj and Bibhtsadarshanj Chhardi
2 Patients with moderate and severe Dehydration
3 Patient suffering from Atisara associated Chhardi
4 Patient suffering from jwar
5 patients with disorder like Liver cirrhosis Renal failure poisoning Hyperthyroidism Congenital anamolies Head injury metabolic disorder
6 Surgical condition like Cholecystitis Intestinal obstruction Cancer of Stomach |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Efficacy of Dhatrirasadiprayog in the management of Chhardi in Childrens |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Efficacy of Dhatrirasadiprayog and Haritaki churna in management of Chhardi in children |
5 days |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
15/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As we see the number of patients with Chhardi are increasing now a days due to fast food , spicy , extra oily food , eating packaged food , so this study help to relieve the symptoms . The study is open randomized controlled trial in which Dhatrirasadiprayog is trial drug and Haritaki Churna is controlled drug . Study will be carried out for 5 days including 1st , 3 rd , 5th day followup . 39 Patients will studied in each group . Study will be conducted in India . Outcome of study will be asses on reduction of sign and Symptoms of Chhardi in Childrens . |