| CTRI Number |
CTRI/2024/05/066799 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| 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 Saindhavadi Churna in Udarshool (Abdominal pain) in children. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Saindhavadi churna in the management of Udarshool(abdominal pain) in children between 6 months and 6 years. |
| 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 Himanshi Deora |
| Designation |
MD Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department ,Dr.D.Y.Patil College Of Ayurved and Research Centre ,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9414951958 |
| Fax |
|
| Email |
himanshideora89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Sahebrao Khawale |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,pimpri pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College Of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshi Deora |
| Designation |
MD Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,pimpri pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College Of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9414951958 |
| Fax |
|
| Email |
himanshideora89@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
India |
|
|
Primary Sponsor
|
| Name |
Dr Himanshi Deora |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College Of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
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 Himanshi Deora |
Dr.D.Y.Patil College Of Ayurved and Research Centre Pimpri Pune 18 |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College Of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri, Pune 18
Pune
MAHARASHTRA |
9414951958
himanshideora89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: UDARA/UDARAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saindhavadi Churna, Reference: Gadh Nigrah,adhyay Kaumartantre Balarogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Go ghrita), Additional Information: Drug dose will be given according to the age. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age group of 6 months to 6years of either gender will be selected.
2.History of frequent abdominal pain.
3.Patients having a history of symptoms of Udarshool (Abdominal pain) mentioned in Kashayap Samhita and modern texts
like excessive crying, stiffness of the abdomen, perspiration of the face, coldness.
4.The patients who are ready for participation in clinical trial by giving informed written consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with any known case of congenital anomalies.
2.Udarshool (Abdominal pain) is associated with Jwar (Fever), Chardi (Vomiting), Atisar(Diarrhea), Pravahika(Dysentery).
3.Patients who require surgical management.
4.Severe persistent and acute abdominal pain.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease episodes of Udarshool(abdominal pain) |
5 days study with follow up on 3rd and 5th day (0,3,5 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect, if any of Saindhavadi Churna. |
5 Days study with follow up on 3rd and 5th day(0,3,5 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)
|
13/05/2024 |
| 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 a single arm clinical study in which the medicine Saindhavadi churna will be provided to 35 patients showing signs and symptoms of Udarshool(abdominal pain). The age group taken for the trial will be between 6 months and 6 year. Saindhavadi churna with go grihta(cow ghee) will be given for 5 days thrice a day. Dose will be calculated according to the dose of churna given in Sharangdhar Samhita. Follow up will be done on the 3rd and 5th day and the total duration of case study will be 5 days. The final conclusion will be drawn based on statistical methods. |