| CTRI Number |
CTRI/2025/07/090564 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Rala Churna In Balatisar. |
|
Scientific Title of Study
|
An Open Randomised Control Clinical Trial To Study the Effect of Rala Churna in The management of Balatisar With Special Reference to 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 |
Dr Sonali Jadhav |
| Designation |
PG Scholer |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta Tq walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
8459617121 |
| Fax |
|
| Email |
sonalijadhav0508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Patil |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta 4th Floor Department of Balrog
4th Floor Department of Balrog
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149364767 |
| Fax |
|
| Email |
drdeepika.infantcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Patil |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta 4th Floor Department of Balrog
4th Floor Department of Balrog
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149364767 |
| Fax |
|
| Email |
drdeepika.infantcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Jadhav |
| Address |
OPD No.5 Balrog OPD Dhanvantari Ayurved Hospital Ashta |
| 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 sonali Jadhav |
Hon Shri Annasaheb Dange Ayurved Medical College and Dhanvantari Ayurveda hospital , ashta, Sangli |
OPD no 5. Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Sangli Maharashtra 416301 Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
8459617121
sonalijadhav0508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator arm -kutaj twak churna |
1.Medicine Name : Kutaj twak churna
2. Reference:Bhavprakash nighantu ( guduchiadi varg )
3. Route: oral , dosage form : churna with madh, Dose :750 mg to 1500 mg as per age of child , frequency: bd , duration:5 days |
| Intervention |
Intervention arm - Rala churna |
1.Medicine Name : Rala churna
2. Reference:Bhavprakash nighantu ( karpuradi varg ), priynighantu ( Haritkayadi varg)
3. Route: oral , dosage form : churna with madh, Dose :250 mg to 1500 mg as per age of child , frequency: bd , duration:5 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in between the age groups of 5 years completed to 10 years irrespective of gender , socioeconomic status .
2. Children having history of Balatisar.
3. Children having classic sign and symptoms of Balatisar.
4. Children having non infective origin of diarrhoea. |
|
| ExclusionCriteria |
| Details |
1. Children suffering from any systemic disorder, congenital anomalies, metabolic disease, immune deficiency disorder.
2. Children suffering from Balatisar with jwar.
3. Children suffering from Pravahika, visuchika, Raktatisar and Chardi.
4. Children of moderate to severe dehydration.
5. Any patient required indoor management. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the efficacy of Rala churna in Balatisar with special reference to diarrhoea in children |
1st day , 3rd day, 5 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of Rala churna with Kutaj twak churna in the management of Balatisar with special reference to Diarrhoea in children.
2. To evaluate the efficacy of Kutaj twak churna in Balatisar with special reference to Diarrhoea in children.
3. To review clinical features, etio-pathogenesis of Atisar and Diarrhoea according to Ayurveda and modern respectively.
4. To observe the adverse effect of Rala churna in Atisar after administration. |
1st day, 3rd day , 5 th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
21/07/2025 |
| 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="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
|
In Ayurveda Atisar is mentioned as a independent disease and found these days in children. Atisar is an outcome of Mandagni according to Madhavnidan
Generally child has more intrest in madhur ahar and in early age of child is also Kapha predominant, this situation leads to Agnimandya which is basic cause Due to westernised lifestyle, irregular meals and sleep, stale food, frozen food Virrudh anna eating fast food and that to at odd times. which is not good for health and causes disease of Gastro-intestinal tract There are also some other factors, which continue to affect the health, they are such as growing population to the urban slums, absence of civil facilities like water supply, drainage adultration and poor quality food unhygine living conditions leads the child suffer from many disease and one of them is Balatisar vyadhi |