| CTRI Number |
CTRI/2025/04/084543 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the Effect of Krushnajeerakadi yog charvan in Mukhapak w.s.r. to Stomatitis. |
|
Scientific Title of Study
|
Randomised Open Control Clinical Study Of Krushnajeerakadi Yog Charvan In Mukhapak W.S.R. To 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 |
Dr Pranali Gajanan Sawarkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD No. 5, Kodoli, Dist. Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7768865860 |
| Fax |
|
| Email |
pranalisawarkar07775@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patil |
| Designation |
PG Guide Associate Professor of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD No. 5, Kodoli, Dist. Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Patil |
| Designation |
PG Guide Associate Professor of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD No. 5, Kodoli, Dist. Kolhapur Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD Patients from Yashwant Ayurvedic Medical College PGT and RC Kodoli Dist. Kolhapur, Maharashtra, India PIN code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Pranali Gajanan Sawarkar |
| Address |
Daily OPD no. 5 , Patients from Yashwant Ayurvedic Medical College PGT and RC Kodoli Dist. Kolhapur, Maharashtra, India PIN code 416114 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranali Gajanan Sawarkar |
Yashwant Dharmartha rugnalay Kodoli Dist Kolhapur |
Yashwant Ayurvedic Medical College PGT and RC Kodoli OPD no 5 Shalakyatantra Department, Kolhapur Maharashtra . Pin no. 416114
Kolhapur
MAHARASHTRA |
7768865860
pranalisawarkar07775@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic Medical College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krushnajeerakadi yog, Reference: Yogratnakar mukharog chikitsa 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -All ingredients of Krushnajeerakadi yog will be taken in equal quantities and mix them well and then make it into churna form . | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatipatra, Reference: Nighantratnakar mukharog prakaran page no 762, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -Jatipatra will be make into churna form. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age group 18 to 60 yr, irrespective of gender ,religion ,occupation ,socio-economic status will be selected randomly for the study. Patient having signs & symptoms of mukhapak. Patient having ulcer dimension up to 4mm.
|
|
| ExclusionCriteria |
| Details |
Inflammatory condition of the oral cavity other than stomatitis. Traumatic injury of mouth(eg- Tooth brush, jagged teeth). Known cases of carcinoma on Treatment of Radiotherapy and chemotherapy. Known case of systematic illness with complications which can interfere with the study. Patient having ulcer dimension more than 4mm.
|
|
|
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 |
| Reducing the no. of ulcers, pain, burning sensation and redness in oral cavity. |
3days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in recurring mouth ulcers along with reducing redness, pain, burning sensation. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/04/2025 |
| 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="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
|
This study is randomised open control clinical trial to evaluate the efficacy of krushnajeerakadi yog charvan in Mukhapak w.s.r. to stomatitis. Study will be carried in OPD of Shalakyatantra Department at Yashwant Ayurvedic Medical College and hospital Kodoli. The observation will be drawn on the basis of symptoms after treatment given. |