| CTRI Number |
CTRI/2022/07/044303 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY THE EFFECT OF VELVET LEAF POWDER IN DIARRHOEA |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study TO Evaluate the Efficacy Of Patha Churna In Balatisar With Special Refference To Diarrhea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VD PRAVATKUMAR DASH |
| Designation |
PROFESSOR HOD |
| Affiliation |
Yashwant Ayurvedic medical college and hospital kodoli Kolhapur |
| Address |
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD PRAVATKUMAR DASH |
| Designation |
PROFESSOR HOD |
| Affiliation |
Yashwant Ayurvedic medical college and hospital kodoli Kolhapur |
| Address |
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VD PRAVATKUMAR DASH |
| Designation |
PROFESSOR HOD |
| Affiliation |
Yashwant Ayurvedic medical college and hospital kodoli Kolhapur |
| Address |
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
O.p.d. No.5,Kaumarbhritya Department,First Floor, Yashwant Ayurvedic Medical College and PG research centre Kodoli Kolhapur Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college,kodoli |
|
|
Primary Sponsor
|
| Name |
Yashwant Ayurvedic Medical College Kodoli kolhapur Maharashtra |
| Address |
Yashwant Ayurvedic Medical College Kodoli kolhapur Maharashtra |
| 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 |
| DrVishvjeet Shashiknat Kumbhar |
Yashwant Ayurvedic College |
Room no.7 Department of kaumarbhritya , Yashwant Ayurvedic College kodoli kolhapur maharashtra
Kolhapur
MAHARASHTRA |
9970062298
vishvjeetkumbhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic Medical College Kodoli Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patha, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.8(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children suffering from Atisar in between the age group of 3 year completed to 12 year.
2) Diarrhea with non Infective origin.
3)Diarrhea with no to some dehydration. |
|
| ExclusionCriteria |
| Details |
1)Children above 12 years and below 3 years of age.
2)Children suffering from atisar with severe dehydration.
3)Children suffering from Pravahika and visoochika.
4)Children suffering from chronic diarrhea.
5)Children suffering from vomiting episodes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective criteria-
Malvega,Dryness of skin ,mouth and tongue& Thirsty
Gradation features-
Malavega -
No 0 - liquid watary stool 2times per day
Mild 1 - liquid watary stool 3-5 times per day
Moderate 2 - liquid watary stool 5-6 times per day
Severe 3 - liquid watary stool 7 times per day
|
patient should be re assess on day 3 and day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete remission 100% |
6th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
31/07/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Study will be conducted in two Groups
Group A= Trial Group = Patha Churna with Madhu Group B = Control Group= Syp. Balchaturbhadra
Patients will be selected randomly in each group fulfilling the Inclusion criteria.
Assessment will be done as per assessment Criteria, before and after treatment in each group.
Results will be analysed Statistically and publish in the form of thesis. |