| CTRI Number |
CTRI/2024/05/067246 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the effect of Lodhradi Churna in Atisara(Diarrhea) in children |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Lodhradi Churna in the management Of Atisara(Diarrhea) in children age 1 year to 12 year |
| 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 Pratik Kailas Auti |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved Pimpri Pune Maharashtra 411018 |
| Address |
OPD No.1 Department of Kaumarbhritya Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8408832595 |
| Fax |
|
| Email |
pratikauti9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Rajpal |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved Pimpri Pune Maharashtra 411018 |
| Address |
OPD No.1 Dapartment of Kaumarbhritya,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Kailas Auti |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil College Of Ayurved Pimpri Pune Maharashtra 411018 |
| Address |
OPD No.1 Dapartment of Kaumarbhritya,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
8408832595 |
| Fax |
|
| Email |
pratikauti9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune,
Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Pratik Kailas Auti |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune, Maharashtra 411018 |
| 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 Pratik Kailas Auti |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Pimpri Pune |
OPD No.1 and IPD
Kaumarbhritya
Department,Dr.D.Y.Pati
l College Of Ayurveda
and Research
Centre,Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8408832595
pratikauti9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K529||Noninfective gastroenteritis and colitis, unspecified. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi Churna, Reference: Vangsen Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient with age group of 1 to 12 years will be selected irrespective
of sex , socio-economic status and food habits.
2)Patient having atleast 2-3 symptoms of atisara(diarrhea) are as
follows:
Dravamalpravritti (Stool frequency)
Malaswaroop (Stool appearance)
Mutrapravritti (Urine output)
Agnimandya(Loos of appetite)
3)Patient of acute diarrhea with mild degree of dehydration.
4)Parents willing for participation of their child in clinical trial and ready
to give written assent.
5)In mild degree of dehydration, if patient need ORS,then it is given. |
|
| ExclusionCriteria |
| Details |
1. Patients having any chronic or systemic illness.
2. Patients of moderate to severe dehydration and requiring
hospital IPD management.
3. Patients suffering from the pravahika,Visuchika, Rakta Atisara.
4. Patient suffering from chronic diarrhea, persistent diarrhea,
diarrhea due to acquired or congenital immune deficiency.
5. Patients having major problem in which required surgical
correction like intussusceptions.
6.Patients having samavastha of disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in frequency and quantity of stool |
0,2,5 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Lodhradi churna |
5 Days study with followup on 2nd and 5th day
(0,2,5 Days)
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/06/2024 |
| 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
|
THIS IS SINGLE ARM CLINICAL STUDY IN WHICH LODHRADI CHURNA WILL BE
PROVIDED TO 35 PATIENTS SHOWING SIGN AND SYMPTOMS OF ATISARA(DIARRHEA)THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE CHILDREN FROM 1YEAR TO 12 YEAR .THE MODE OF DRUG ADMINISTRATION WILL BE ORAL THRICE IN A DAY.FOLLOW UP WILL BE DONE ON 2ND AND 5TH DAY AND
TOTAL DURATION OF CASE STUDY WILL BE 5 DAYS.THE FINAL CONCLUSION WILL BE
DRAWN ON THE BASIS OF STATISTICAL METHODS. |