| CTRI Number |
CTRI/2026/04/109262 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Rajanyadi Churna in treating diarrhea (Atisar) in children aged 1–5 years. |
|
Scientific Title of Study
|
Randomised controlled trial to evaluate the efficacy of Rajanyadi churna in management of
Balatisar with reference to acute diarrhoea in children of age group 1 to 5 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 |
KIRAN RAMESH MUDGIRE |
| Designation |
PG Resident, Kaumarbhritya Department |
| Affiliation |
PMT’S AYURVED COLLEGE SHEVGAON |
| Address |
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9075962306 |
| Fax |
|
| Email |
mudgirekiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.KISHOR.D.PACHARNE |
| Designation |
HOD |
| Affiliation |
PMT’s Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra, India. |
| Address |
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881711719 |
| Fax |
|
| Email |
dr.kishor.vatsalya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KISHOR D PACHARNE |
| Designation |
HOD |
| Affiliation |
PMT’s Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra, India. |
| Address |
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9881711719 |
| Fax |
|
| Email |
dr.kishor.vatsalya@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTS Ayurved College Shevgaon Akhegaon Road Shevgaon Dist Ahilyanagar Maharashtra 414502 |
|
|
Primary Sponsor
|
| Name |
KIRAN RAMESH MUDGIRE |
| Address |
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, 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 |
| KIRAN RAMESH MUDGIRE |
PMT’s Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra, India. |
OPD No. 7, Kaumarbhritya Department, PMTS Ayurved College and Shri Eknath Rugnalaya, Shevgaon, Ahilyanagar, Maharashtra – 414502, India.
Ahmadnagar
MAHARASHTRA |
9075962306
mudgirekiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pmt’s Ayurved College Shevgaon |
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: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajanyadi Churna , Reference: Bhaishjyaratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kutajatvak Churna , Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1.Children with classical signs and symptoms of Balatisar (diarrhoea) .
2.Children aged above 1 years upto 5 years, irrespective of gender, socioeconomic background and
religion.
3.parents of children willing to give written consent .
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Children exhibiting moderate to severe dehydration .
2.Children with known case of systemic illnesses, congenital abnormalities, metabolic disorders, or
immunodeficiency conditions.
3.Children who require in-patient hospital care for their condition. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Udarashoola
Daurbalya and Degree of Dehydration |
2 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in associated symptoms of
Malavega
Malasamhanan |
5Days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2026 |
| 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 present randomized parallel-group, open-label clinical trial aims to evaluate the efficacy of a classical Ayurvedic formulation, Rajanyadi churna in the management of Balatisar and compare its effects with kutajtwakchurna another classical formulation. A total of 76 participants diagnosed with Balatisar will be recruited and randomly allocated into two groups.
Participants in the intervention group will receive Rajanyadi churna 600mg to 3000mg bd in powder form, while the comparator group will receive kutajtwakchurna bd for a duration of 5 days. Clinical assessments will be performed on 0th,3rd,5th day
The primary outcome measures include reduction in classical symptoms associated with Balatisar udarashoola, Daurbalya,and Degree of Dehydration. Objective parameters including malavega ,udarashoola,Daubarlya,Malaswaroopa,Degree of Dehydration.
The study aims to generate scientific evidence regarding the effectiveness of classical Ayurvedic formulations in the management of Balatisar and may provide a safe and cost-effective therapeutic option for patients. |