| CTRI Number |
CTRI/2025/09/095431 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to see the Effect of Pathadi Churna and Mridvikadi Churna in Treatment Tonsillitis (Tundikeri) in Children |
|
Scientific Title of Study
|
A Randomized Open Label Comparative Clinical Study to
Evaluate the Efficacy of Pathadi Churna and Mridvikadi Churna in the Management of Tundikeri (Tonsillitis) 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 Vishal Kashinath Kashte |
| Designation |
P G Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
PG Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7767981976 |
| Fax |
|
| Email |
vishalkashte4444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vd S D Sharma |
| Designation |
Chairperson PG Dept of Kaumarbhritya |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
PG Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7988688231 |
| Fax |
|
| Email |
sharmasddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Kashinath Kashte |
| Designation |
P G Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Former Shri Krishna Govt. Ayurvedic College |
| Address |
PG Department of Kaumarbhritya Institute for Ayurved Studies and
Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7767981976 |
| Fax |
|
| Email |
vishalkashte4444@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College
and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Former Shri Krishna
Government Ayurvedic College and Hospital Shri Krishna AYUSH
University Umri Road Sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Government 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 Vishal Kashinath Kashte |
Institute for Ayurved Studies and Research |
PG Department of
Kaumarbhritya Institute
for Ayurved Studies and
Research Former Shri
Krishna Government
Ayurvedic College and
Hospital Umri Road
Sector 8 Kurukshetra
136118
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
07767981976
vishalkashte4444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna AYUSH University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi Churna, Reference: Charak chikitsa 26/199, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mridvikadikadi churna, Reference: Charak chikitsa 26/198, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Parents of children willing to participate in the research trial.
Children of age group 05-15 years. Irrespective of Caste, Sex, Religion and socioeconomic status.
The patient having classical sign and symptoms of Tundikeri (Tonsillitis) in children. |
|
| ExclusionCriteria |
| Details |
Patients with age below 5 year and above 15 years.
Children having any systemic disorders like TB, DM, Cardiac and renal problems.
Patient having congenital anomalies
Children Suffering from Peri-Tonsillar Abscess, Tonsillar Cyst, And Tonsillolith. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will be assessed on the basis of statistical analysis applied on subjective parameter Jwara Kasa Kantha Vedna Tundikeri Vriddhi Lasika Granthi Vriddhi Gala Upardha and objective parameter CBC ESR CRP Friedman Grading Scale For Tonsillits after completion of trial |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life in children |
14th day 21th day 28th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="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
|
This randomized open-label comparative clinical study aims to evaluate the efficacy of Pathadi Churna and Mridvikadi Churna in the management of Tundikeri (Tonsillitis) in children. A total of 66 participants (33 in each group) aged 5–15 years will be enrolled using computer-assisted randomization. The intervention involves oral administration of the respective trial drugs as per pediatric dosing, twice daily after meals, for a duration of 14 days. Clinical assessment will be based on both subjective parameters (fever, cough, throat pain, dysphagia, tonsillar swelling) and objective criteria (CBC, ESR, CRP, Friedman grading). The study anticipates significant reduction in clinical symptoms, improved quality of life, and validation of Ayurvedic formulations as safe and effective alternatives in pediatric tonsillitis.
|