| CTRI Number |
CTRI/2025/05/086732 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the effectiveness of Tiladi Gandush in treating stomatitis in children. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the clinical efficacy of tiladi gandush in the management of mukhapaka w.r.t to stomatitis 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 Rahul Sanjay Tathe |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Room no. 2 Kaumarbhritya department Gadhinglaj Kolhapur India
Pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822441876 |
| Fax |
|
| Email |
rahultathe0206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Gurav |
| Designation |
Professor at Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Room no. 2 Kaumarbhritya department Gadhinglaj Kolhapur India
Pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822187049 |
| Fax |
|
| Email |
Rasaihospital@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Gurav |
| Designation |
Professor at Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Room no. 2 Kaumarbhritya department Gadhinglaj Kolhapur India
Pin 416502
MAHARASHTRA
416502
India |
| Phone |
9822187049 |
| Fax |
|
| Email |
Rasaihospital@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Rahul Sanjay Tathe |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Room no. 2 Kaumarbhritya department, Gadhinglaj Kolhapur India
Pin 416502 |
| 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 Rahul Sanjay Tathe |
Late Kedari Redekar Dharmaday Rugnalaya Gadhinglaj Kolhapur |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Room no. 2 Kaumarbhritya department, Gadhinglaj Kolhapur India
Pin 416502
Kolhapur
MAHARASHTRA |
9822441876
rahultathe0206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Gandush | (Procedure Reference: Nighanturatnakar part 1 chapter gandushadi prakaran, Procedure details: Take haridra,nimba patra,yashtimadhu,neelkamal in equal quantity & sesame oil. Mixed all this contents well & form oil according to sneha kalpana & hold 10-20 ml of the medicated liquid in the mouth without doing any movement inside the mouth.)
| | 2 | Intervention Arm | Procedure | - | Gandush | (Procedure Reference: Nighanturatnakar part 1 chapter gandushadi prakaran, Procedure details: Take tila churna,nilophar churna,ghrit,sugar & honey each 10 gram & milk 100 ml. Mixed all this contents well & hold 10-20 ml of the medicated liquid in the mouth without doing any movement inside the mouth.)
|
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group 8 to 12 years either gender
2.Patient having sign and symptoms of mukhapaka as mentioned in ayurvedic classics like lalastrav(salivation), ruja(pain),mukhavran(ulceration,also irritability, difficultly in deglutition.
3.Irrespective of sex, education status, socio-economic status. |
|
| ExclusionCriteria |
| Details |
1.Age below 8 years were excluded.
2.Patient having traumatic and infective stomatitis.
3.Age above 12 years were excluded.
4.known case of malignancy, leukemia, syphilis, HIV, tuberculosis.
5.patient having carcinogenic ulcers or chronic ulcers in oral cavity. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tiladi Gandush is effective in the management of mukhapaka |
Initial assessment at day 0
Follow up at 3rd,5th,7th,10th day
Final assessment at day 10th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tiladi Gandush is more effective than haridradi tail gandush in the management of mukhapaka |
Initial assessment at day 0
Follow up at 3rd,5th,7th,10th day
Final assessment at day 10th |
|
|
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)
|
31/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/05/2025 |
| 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 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
|
The study is randomized controlled clinical trial to evaluate the clinical efficacy of tiladi gandush in the management of mukhapaka with special reference to stomatitis in children. Study will be carried out at OPD of Kaumarbhritya department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj. The observation will be drawn on the basis of symptoms after treatment is given. |