| CTRI Number |
CTRI/2025/01/079036 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find the effect of Bilwadi syrup and Samangadi syrup in the treatment of Atisar ( loose motions). |
|
Scientific Title of Study
|
A clinical comparative study to evaluate the efficacy of Bilwadi syrup and Samangadi syrup in the management of Atisar with special reference to acute diarrhea. |
| 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 Vrushali Rajendra Darekar |
| Designation |
M.D. Scholar Kaumarbhritya |
| Affiliation |
|
| Address |
Department of Kaumarbhritya- Bala Roga, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi , Nashik
Kaumarbhritya of Department- Bala Roga, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi , Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7875273072 |
| Fax |
|
| Email |
vrushalidarekar75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIpul Ramesh Dixit |
| Designation |
Assistant Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Kaumarbhritya- Bala Roga, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi , Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9172841885 |
| Fax |
|
| Email |
dr.vipuldixit4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali Rajendra Darekar |
| Designation |
M.D. Scholar Kaumarbhritya |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Kaumarbhritya- Bala Roga, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi , Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7875273072 |
| Fax |
|
| Email |
vrushalidarekar75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hirawadi , Nashik 422003. |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Kaumarbhritya balroga, Shree Saptashrungi Ayurved Mahavidyalaya , Kamalnagar Hirawadi, Nashik 422003, 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 |
| Dr Vrushali Darekar |
Shree Saptashrungi Ayurved Mahavidyalaya |
Department of Kaumarbhritya balroga, Shree Saptashrungi Ayurved Mahavidyalaya , Kamalnagar Hirawadi, Nashik 422003, Maharashtra
Nashik
MAHARASHTRA |
7875273072
vrushalidarekar75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D Shree Saptashrungi Ayurved Mahavidyalaya , Kamalnagar Hirawadi, Nashik 422003, Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Samangadi kwatha, Reference: Chakradatta, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: - Koshnajala), Additional Information: classical kwatha is converted into syrup form to make the formulation more palatable to children. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilwadi Kwatha, Reference: Chakradatta, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: Classical kwatha is converted into syrup form to make the formulation more palatable to children. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Irrespective of sex, socioeconomic condition and religion.
2 Patients with classical signs and symptoms of Atisara.
3 Patients with some degree of dehydration.
4 Patients fulfilling the diagnostic criteria of Atisar as per CRF. |
|
| ExclusionCriteria |
| Details |
1 Patients with severe dehydration and seriously ill cases.
2 Patients having or suffering from any other diseases Eg. Bronchopneumonia , Hepatitis, Typhoid
3 Patients with systematic disorders eg Asthma, congenital heart disease.
4 Patients with autoimmune disorders.
5 Patients having any complications.
6 Patients younger than 6 years and older than 12 years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce sign and symptoms of Atisar. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved appetite, digestion. |
5 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)
|
08/12/2025 |
| 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 Yet Recruiting |
| 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
|
OBJECTIVES :
1. To compare the efficacy of Bilwadi syrup and Samangadi syrup in management of atisara w.s.r. to acute diarrhea.2. Study the literature related to atisara according to classical ayurveda text. 3. To study diarrhea in detail according to modern aspect.
PERTICIPANTS:
The children of age group 6-12 years diagnosed with Atisar meeting inclusion and exclusion criteria from OPD department of Kaumarbhritya of Shree Saptashrungi Ayurved Mahavidylaya and hospital Nashik.
Interventions :
30 patients Bilwadi syrup : Administered according to standard protocol. 30 patients Samangadi syrup : Administered according to standard protocol.
Primary Outcomes :
Reduce the sign and symptoms of Atisar.
Secondary Outcome :
Improved digestion , appetite.
Treatment Duration : 5 days.
Follow up : 3rd day and 5th day
Data Analysis : Data will be analyzed using appropriate statistical methods to compare the effectiveness of the intervention.
Ethical Considerations : The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |