| CTRI Number |
CTRI/2025/06/089388 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study of Pippalyadi Medicated Mouth Wash And Triphala Medicated Mouth Wash In Mouth Ulcer |
|
Scientific Title of Study
|
An Open Label Double Arm Randomised Clinical Study To Evaluate The Efficacy Of Pippalyadi Kalka Kavalagraha And Triphala Kalka Kavalagraha In The Management Of Mukhapaka Wsr Aphthous Ulcer |
| 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 Saraswathi Swethasree |
| Designation |
Post Graduate Scholar |
| Affiliation |
sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College
Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And
Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India
SKAMC And RC Vijayanagara Banglore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8919095546 |
| Fax |
|
| Email |
Swethashekhar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Post graduate scholar |
| Affiliation |
sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College
Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And
Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India
SKAMC and RC Vijayanagara banglore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Post Graduate Scholar |
| Affiliation |
sri kalabyraveshwara swamy ayurvedic medical college and research centre Vijayanagara banglore 560104 |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College
Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And
Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India
SKAMC And RC Vijayanagara banglore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Saraswathi Swethasree Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical
College Hospital And Reseach Centre Vijayanagar Bangalore karnataka India 560104
|
|
|
Primary Sponsor
|
| Name |
Dr Saraswathi Swethasree |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Banglore Karnataka India 560104
skamc and rc vijayanagara banglore 560104 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran M Goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
Room no 21 Dept Of PG Studies In Shalakya
Tantra Sri Kalabyraveshwara Swamy Ayurvedic
Medical College Hospital And Reseach Centre
Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skamchrc |
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 | Procedure | - | kavalaH, कवलः | (Procedure Reference: Charaka Samhitha , Procedure details: Pippalyadi Churna Along With Honey Is Made Into Bolus Form. It Is Held And Moved Inside The Mouth Till Samyak Kavala Lakshanas Are Observed. It Is Given 1 Hour Before Food Thrice a Day)
(1) Medicine Name: Pippalyadi Churnam, Reference: Charaka Samhitha , Route: Oral, Dosage Form: Kalka/ Paste, Dose: 12(g), Frequency: tds, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Yogaratnakara, Procedure details: TriphaladiChurna Along With Honey Is Made Into Bolus Form. It Is Held And Moved Inside The Mouth Till Samyak Kavala Lakshanas Are Observed. It Is Given 1 Hour Before Food Thrice a Day. )
(1) Medicine Name: Triphaladi Churnam, Reference: Yogaratnakara, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 12(g), Frequency: tds, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with lakshanas of Mukhapaka
Subjects with signs and symptoms of Aphthous ulcers
Subjects of either gender between 20 to 60 years of age
|
|
| ExclusionCriteria |
| Details |
Subjects having history of chronic non healing mouth ulcers as in malignancy leukaemia syphilis HIV Herpes gingivostomatitis
subject having history of any other systemic illness that may interfere with the course of treatment
|
|
|
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 |
| to see the rate of healing of ulcer redness lalasrava ruja burning sensation by giving pippalyadi kalka kavalagraha and triphala kalka kavalagraha in the management of mukhapaka wsr to aphthous ulcers |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/07/2025 |
| 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="1"
Months="6"
Days="5" |
|
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
|
Hence present study is carried out to compare the effect of pippalyadi kalka kavalagraha and triphala kalka kavalagraha in the management of Mukhapaka w.s.r to Aphthous ulcer. |