| CTRI Number |
CTRI/2025/03/082835 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of panchavalkal kwatha with madhu gandush in the stomatitis |
|
Scientific Title of Study
|
Randomized open clinical controlled trial to Study the efficacy of Gandusha of panchvalkal Kwatha with madhu in Mukhapaka w.s.r. stomatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitanyaprakash Valavi |
| Designation |
PG scholar kaumarbhritya |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. Kaumarbhritya department,OPD,And IPD
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
08485843719 |
| Fax |
|
| Email |
valavichaitanya848584@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VdShailesh Raghunath Rajgolkar |
| Designation |
Reader |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre, Panchkarma Department OPD Kodoli, Tal. Panhala Dist. Kolhapur, State.Maharashtra 416114 India
Yashwant ayurvedic college post graduate training and research centre, Kodoli.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308410222 |
| Fax |
|
| Email |
shaileshrajgolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VdShailesh Raghunath Rajgolkar |
| Designation |
Reader |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre, Panchkarma Department OPD Kodoli, Tal. Panhala Dist. Kolhapur, State.Maharashtra 416114 India
Yashwant ayurvedic college post graduate training and research centre, Kodoli.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308410222 |
| Fax |
|
| Email |
shaileshrajgolkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Chaitanyaprakash Devram Valavi |
| Address |
Kaumarbhritya OPD and Ipd Ground floor kaumarbhritya dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
| 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 |
| Chaitanyaprakash Devram Valavi |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
Kaumarbhritya OPD and IPD Ground floor kaumarbhritya dept Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA |
08485843719
valavichaitanya848584@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Panchavalkal kwatha , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Name of Drug 1 vata, 2 udumbar, 3 ashwattha ,4 parish, 5 plaksha,all churnas of above drugs taken in same quantity.and mixed with 16 times water and boil it till 1/8th quantity of water remained.add madhu as prakshep dravya 8 times of churna dravyas. This kwatha is used as gandusha twice a day for 10 days. |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with classical signs symptoms of mukhapak like,formation of ulcers, salivation, irritability (painful mouth),Difficulty in mastication & deglutition.
2. Either male or female patient irrespective of cast, socio- economic status & gendre.
3. Age group - 10 yrs., to 15 yrs.
4. Only those patients will be selected whose parents are willing to give written consent
5. Traumatic stomatitis.
6. Infective stomatitis. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from immunodeficiency conditions like AIDS,cancer(taking chemotherapy),etc.
2. Patients suffering from uremic stomatitis 3. Patient suffering from stomatitis due to nutritional deficiency. |
|
|
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 |
| Releif from pain, ulceration, salivation due to stomatitis |
3rd day,7th day and 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from pain, ulceration,and excessive salivation . |
3rd day, 7th day,10th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/04/2025 |
| 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="3"
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
|
To study the effectiveness of panchavalkal kwatha with madhu gandusha in management of mukhpak w.s.r. stomatitis. The study will be carried in the OPD and IPD of kaumarbhritya department of Yashwant Ayurvedic College and Hospital Kodoli Tal. Panhala Dist. Kolhapur.The conclusion would be drawn on the basis of symptoms after treatment is g |