| CTRI Number |
CTRI/2025/05/086251 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the Effect of Shreerasadi Churna in Decreasing Diarrhea in Childrean Age Group 1 to 12 Year. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Shreerasadi Churna in Atisara (Diarrhea) in Children Age Group 1 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 Omkar Sampat Madake |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of
Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9623904244 |
| Fax |
|
| Email |
omkarmadke999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Bhagwat |
| Designation |
Asso. professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of
Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7588562700 |
| Fax |
|
| Email |
sbhagwat777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omkar Sampat Madake |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of
Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09623904244 |
| Fax |
|
| Email |
omkarmadke999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Omkar Sampat Madake |
| Address |
Dr. D. Y. Patil College of Ayurved 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 Omkar Sampat Madake |
Dr. D. Y. Patil College of Ayurved and Research Centre |
OPD No.1 & IPD,
Kaumarbhritya Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra
Pune
MAHARASHTRA |
9623904244
omkarmadke999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shreerasadi Churna, Reference: Yogratnakar by vd.shrilakshimipatishastri ,vidyotini hindi tika sahit ,chapter 48th balrogadhikar atisaragrahanyochikitsa, shlok no. 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(NA), 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 1 year to 12 year age group will be selected irrespective of sex, religion & socio economic class.
2. Patient of acute diarrhea with no signs of dehydration(according to WHO).
3. Atisara less than 5 days (less than 6 episodes/day). ORS will given to the patient.
4. Patient having classical signs & symptoms of Atisara (Diarrhea). |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from persistent diarrhea, chronic diarrhea, pravahika ,persistent
vomitting.
2. Diarrhea due to any immune deficiency like acquired or congenital.
3. Patients of some dehydration to severe dehydration (according to WHO)
4. Patients suffering from any chronic or systemic illness.
5. Atisara due to any food poisoning or iatrogenic origin. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will see the effect of interventional drug on the signs & symptoms of Atisara are expected to be reduced after the use of Shreerasadi Churna in childrens. |
5 days study with follow up on 2nd and 5th day
(0,2,5 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
We will see reoccurrence and any side effect of interventional drug.
|
5 days study with follow up on 2nd and 5th day
(0,2,5 days) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
10/05/2026 |
| 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) |
Open to Recruitment |
|
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 a single arm clinical study in which the medicine "Shreerasadi Churna” will be provided to 32 patients showing sign and symptoms of Atisara (Diarrhea). The age group taken for the study trial will be in between 1 years to 12 years. Shreerasadi Churna with Madhu will be given on 0 th day Thrice a Day for 5 days. Dose will be calculated by age formula. Follow up will be done on 2nd and 5th day and the total duration of case study will be 5 days. The final conclusion will be drawn on the basis of statistical methods. |