| CTRI Number |
CTRI/2025/09/094183 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
It is a study to see how much effective is ayurvedic medincine Jeerak ark in the treatment of disease infantile colic |
|
Scientific Title of Study
|
Single arm clinical study to assess the efficacy of Jeerak Ark in Udarshool with special reference to Infantile Colic. |
| 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 Bushra Imran Shaikh |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital,PG Institute and Research Centre Urun Islampur. |
| Address |
Paediatric department 2 nd floor LRP Ayurvedic Medical College and hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8208174741 |
| Fax |
|
| Email |
bushrashaikh072@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Patil |
| Designation |
Assistant Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
Paediatric department 2 nd floor LRP Ayurvedic Medical College and hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Patil |
| Designation |
Assistant Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
Paediatric department 2 nd floor LRP Ayurvedic Medical College and hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Bushra Imran Shaikh |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur 415409 |
| 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 Bushra Shaikh |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur |
Department of Kaumarbhritya OPD 2 Sangli Maharashtra
Sangli
MAHARASHTRA |
08208174741
bushrashaikh072@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC -LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur |
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: Other, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jeerak ark, Reference: Buavprakash nighantu 1/54,55, Route: Oral, Dosage Form: Arka, Dose: 16(drops), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
1 Patient of age group from neonate to 6 month
2 Patient will be selected irrespective of age sex religion socio economic condition and geographical distribution
3 Full term healthy neonate suffering from definitive symptoms of infantile colic
4 Patient regularly passes urine and stool normally
5 Patient having bloating and distended abdomen followed by continuous cry
|
|
| ExclusionCriteria |
| Details |
1 Patient more than 6 month
2 Patient associated with symptoms like diarrhea fever and any other pathology
3 Patient who is having congenital anomoly or metabolic problem
4 Patient with unstable vitals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Jeerak Ark in Udarshool with special reference to Infantile Colic |
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the clinical textual review of Udarshool in neonate according to ayurveda and Infantile Colic according to modern text
2 To study efficacy of Jeerak Ark in management of Infantile Colic
3 To prepare Jeerak Ark as per standard methods |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
12/09/2025 |
| 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="0"
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
|
Aim-To study the efficacy of Jeerak Ark in the management of Udarshool with special reference to Infantile Colic
Primary objective-To study the efficacy of Jeerak Ark in the management of Udarshool in infants
Secondry objective-To study literature regarding Udarshool in ayurveda literature To study literature regarding Infantile Colic (Abdominal pain) from modern perspective
Study design-Single arm purposive clinical trial
Study setting-Patient will be selected in OPD and IPD of Kaumarbhritya department in our hospital
Duration of study-18 months
Duration of treatment-6 days
Follow up-1st hr,2nd day,4th day,6th day
Diagnostic phase-Patient will be diagnosed on lakshanas of Udarshool described in ayurvedic classics modern symptoms
Informed written consent will be taken prior to clinical study
Case will be recorded on specially designed proforma
Assessment phase-Subjective Parameter- 1 Rodan(cry) 2 Stanam vyadasyaste (Aversion to feed) 3 Skin on touch (cold and perspiration) 4 Duration of spasm
Objective parameter- 1 Frequency of sleep disturbances 2 Vomiting in 24 hr period
Discussion will be made scientifically in details after results and conclusion will be drawn
The efficacy of drug will be concluded on the basis of observation and statistical analysis
On the basis of observation,result and discussion summary will be drawn and whole disc5 work will be summarised
|