| CTRI Number |
CTRI/2024/10/075566 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to compare the efficacy of oral administration of bilwa-jeeraka syrup with balchaturbhadra syrup in diarrhoea in children |
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare the efficacy of oral administration of bilwa-jeeraka syrup with balchaturbhadra syrup in atisara (diarrhoea) in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Prakash Kale |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9823731894 |
| Fax |
|
| Email |
mkale282@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajanan A Cheke |
| Designation |
Associate Professor Kaumarbhritya Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
80877909907 |
| Fax |
|
| Email |
drgajanancheke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Prakash Kale |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9823731894 |
| Fax |
|
| Email |
mkale282@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,
Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Kaumarbhritya 1st floor 583/2 Rasta Peth Pune 411011
|
| 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 |
| Dr Manoj Prakash Kale |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department, Rastapeth, 583/2, Pune 411011.
Pune
MAHARASHTRA |
09823731894
mkale282@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B999||Unspecified infectious disease. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwa-Jeerak Syrup, Reference: Chikitsaarnav balakrogchikitsaadhikar uttarardha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Balchaturbhadra Syrup, Reference: Bhaishyajaratnavali balrogadhikar 71/39, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children presenting with classical signs and symptoms of atisara-roga (DIARRHOEA).
children suffering from atisara in between the age group 3 years to 10 years of age irrespective of
gender.
children with mild dehydration. |
|
| ExclusionCriteria |
| Details |
children suffering from moderate to severe dehydration.
children who is suffering from genetic disorder ,HIV, VDRL, HBsAg positive
children who is immunocompromised. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in no. of stools, normal thirst, stool texture and urine output |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in no. of stools, normal thirst, stool texture and urine output |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/10/2024 |
| 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
|
The study will be intervened by the treatment of Bilwa-Jeerak Syrup and Balchaturbhadra Syrup to group A and group B respectively. The efficacy of the therapy will be assessed on the
basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity
of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of
each symptom will be calculated before treatment, after treatment and after follow up. The effect of
treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading
and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring
method. |