| CTRI Number |
CTRI/2024/12/077934 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF PANCHAPALLAV KWATH GEL IN PITTAJ SARVASAR (MUKHAPAK) |
|
Scientific Title of Study
|
Title Open Randomized Control Clinical Trial Of Panchapallav Kwath Gel In Pittaj Sarvasar With Special Refefence To Apthous 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 Nikita Doke |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Hon Shri Annasaheb Dange Ayurved medical College Post Graduation And Research Center ashta Tq walwa Dist Sangali Maharashtra 416301 Shalakyatantra Department Floor 5th.
Sangli
MAHARASHTRA
416301
India |
| Phone |
7620038982 |
| Fax |
|
| Email |
nikitadoke3197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VdJayvant kharat |
| Designation |
H.O.D |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved medical College Post Graduation And Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved medical College Post Graduation And Research Center Ashta Tq walwa Dist Sangali Maharashtra 416301 Shalakyatantra Department 5th Floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VdJayvant kharat |
| Designation |
H.O.D |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved medical College Post Graduation And Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved medical College Post Graduation And Research Center Ashta Tq walwa Dist Sangali Maharashtra 416301 Shalakyatantra Department 5th Floor
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon.Shri Annasaheb Dange Ayurved Medical College PG and Research center Ashta tq walwa dist sangali 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Doke |
| Address |
Shalakyatantra Opd Danvantari Ayurved hospital Ashta tq walwa dist sangali 416301 |
| Type of Sponsor |
Private 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 |
| DrNikita Doke |
Danvantari Hospital Ashta,Sangli. |
Hon.shri Annasaheb Dange Ayurved Medical college PG and Research center ashta
Sangli
MAHARASHTRA |
7620038982
nikitadoke3197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon.Shri Annasaheb Dange Ayurved Medical College PG and Research center Ashta Institutional Ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: PITTAJA-SARVASARA-MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: orasep gel , Reference: P.L. Dhingra & Swati Dhingra. , Route: Oral, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: panchapallav gel , Reference: यो.र.म.à¤à¤¾à¤— 2, 307 , Route: Oral, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having signs & symptoms of Pittaj Sarvasar(daha,raktavarnata, sphota).
2.Patients between the age group 18 to 50 years (2
3.Patients with aphthous stomatitis minor.
4.Patients with traumatic stomatitis, bacterial, burn injuries, drug allergy stomatitis,vit.B deficiency .
5. Patients irrespective of Gender, religion, occupation, socio-economic status educational status, marital status, caste, will be selected randomly for the study.
6.patient having ulcer dimenstion less than 4to 5 mm.
|
|
| ExclusionCriteria |
| Details |
1.Traumatic injury of mouth (eg- jagged teeth, dental procedural trauma)
2.Patient’s duration of course suffering from any systemic illness which interfere the of duration course i.e DM, Asthma, HIV, AIDS,viral disease (e.g -Herpes zoster), bacterial (Syphilis), Fungal.
3.Cases of Carcinoma on Treatment of Radiotherapy and chemotherapy.
Patients with recent history of use of NSAID’s (Non- Steroidal, Anti Inflammatory Drugs).
4.Patient having ulcer dimension more than 5mm.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| panchapallavkwath gel is effective in management of Pittaj Sarvasar. |
3 times per day for 7 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Orasep gel is effective in management of Pittaj Sarvasar. |
3 times per day for 7days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
25/12/2024 |
| 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
|
According to modern science mukhpak is nothing but stomatitis i.e inflammation of the mouth.Pittaj mukhapak is occurred recurrently.Prevalence rate of pittaj mukhapak is 21.7%. According to ayurveda pratisaran is one of the upkarmas mentioned in dincharya and ancient indian ayurvedic apporach adopted for healing,relaxation and treating various types of disease.Gel formulatiom with hrebal ingredients such as panchpallav,madhu has good characterististic,viscosity and a good antimicrobial acivity which is necessary in the management of mouth ulcers. |