| CTRI Number |
CTRI/2025/07/090183 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison between Khadiradi vati and yavagrajadi gutika in Tundikeri |
|
Scientific Title of Study
|
A Comparative clinical study on efficacy of Khadiradi vati and Yavagrajadi gutika in the management of Tundikeri w s.r. tonsilities 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 Satyendra Songara |
| Designation |
P.G. Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College & hospital , bhopal , M.P. |
| Address |
P.G. department of kaumarbhritya , O.P.D. No.- 4 , Rani Dullaiya Smriti Ayurved PG Mahavidyalaya Evam chikitsalaya , Barkhedi Kalan , Bhopal ,M.P.
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
9074256907 |
| Fax |
|
| Email |
ssongara999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPAK JAIN |
| Designation |
READER in Kaumarbhritya |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College & hospital , bhopal , M.P. |
| Address |
P.G. department of kaumarbhritya , O.P.D. No.- 4 , Rani Dullaiya Smriti Ayurved PG Mahavidyalaya Evam chikitsalaya , Barkhedi Kalan , Bhopal ,M.P.
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
9993304900 |
| Fax |
|
| Email |
dr.deepakjain86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPAK JAIN |
| Designation |
READER in Kaumarbhritya |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College & hospital , bhopal , M.P. |
| Address |
P.G. department of kaumarbhritya , O.P.D. No.- 4 , Rani Dullaiya Smriti Ayurved PG Mahavidyalaya Evam chikitsalaya , Barkhedi Kalan , Bhopal ,M.P.
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
9993304900 |
| Fax |
|
| Email |
dr.deepakjain86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved P.G. College & Hospital , Bhopal , M.P.,India, 462044 |
|
|
Primary Sponsor
|
| Name |
Dr Satyendra Songara |
| Address |
P.G. department of kaumarbhritya , O.P.D. No.- 4 , Rani Dullaiya Smriti Ayurved PG Mahavidyalaya Evam chikitsalaya , Barkhedi Kalan , Bhopal ,M.P.,India ,462044 |
| 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 |
| DR SATYENDRA SONGARA |
Rani Dullaiya Smriti Ayurved pg College & Hospital , Bhopal |
PG department of kaumarbhritya , O.P.D. No. 4 , Rani Dullaiya Smriti Ayurved PG Mahavidyalaya Evam chikitsalaya , Barkhedi Kalan , Bhopal ,M.P.
Bhopal
MADHYA PRADESH |
09074256907
ssongara999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Rani Dullaiya Smriti Ayurved PG College & Hospital , Bhopal ,M.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B978||Other viral agents as the cause ofdiseases classified elsewhere. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: YAVAGRAJADI GUTIKA, Reference: gada nigraha 130, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: YAVAGRAJADI GUTIKA in tundikeri | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: khadiradi vati, Reference: bhaisajya ratnavalli, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: KHADIRADI VATI in tundikeri |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
The patients having classical symptoms of tundikeri
Age above 5 years and below 16 years of either sex.
Children whose parent’s give informed consent
|
|
| ExclusionCriteria |
| Details |
Patient below age 5 and above 16 years.
Patients suffering from infectious diseases.
Patients with peritonsillar abscess, tonsillar cyst, and tonsillolith were excluded.
Patients with K/C/O HIV, TB, and HepB were excluded.
Patient having complaints of severe systemic illness will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient will get relief from sign and symptoms of tundikeri |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effectivness of yavagrajadi gutika in the management of tundikeri |
14 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)
|
16/07/2025 |
| 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="0"
Months="3"
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 is a double group , open label , comparative clinical study to evaluate on the efficacy of khadiradi vati and yavagrjadi gutika in management of tundikeri . Patient assesed according to subjective and objective criteria for managing tundikeri . the primary outcome is to manage sign and symptoms of tundikeri and secondary outcome is to assess effectiveness of yavagrjadi gutika in managing tundikeri sign and symptoms . |