| CTRI Number |
CTRI/2022/05/042947 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of 2 formulations, Darvi rasakriya and Yashtimadhu rasakriya in the treatment of Mukhapaka (Aphthous stomatitis) |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Darvi rasakriya pratisarana and Yashtimadhuka rasakriya pratisarana in Mukhapaka (Aphthous stomatitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayana B |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of PG Studies in Shalakyatantra, Alvas Ayurveda Medical College and Hospital, Moodbidri, D.K, Karnataka - 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8547223223 |
| Fax |
|
| Email |
nayanabalan23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE affliated with RGUHS |
| Address |
Associate professor and Head of the Department
Department of PG Studies in Shalakyatantra, Alvas Ayurveda Medical College and Hospital, Moodbidri, D.K, Karnataka - 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha D Rao |
| Designation |
Associate professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE affliated with RGUHS |
| Address |
Associate professor and Head of the Department
Department of PG Studies in Shalakyatantra, Alvas Ayurveda Medical College and Hospital, Moodbidri, D.K, Karnataka - 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7411360991 |
| Fax |
|
| Email |
drapekshadrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
Balan R |
| Address |
Kallingal house, Athiyampadamkalam, Pudunagaram P.O, Palakkad, Kerala, 678503 |
| Type of Sponsor |
Other [Father] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jijil N T |
Bappuji house, Nhendadithodi, Pantheeramkave, Payyadimeethal, Kozhikode, 673019 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayana B |
Alvas Ayurveda Medical College and Hospital |
Shalakyatantra OPD & IPD, Alvas Ayurveda Medical College and Hospital, Moodbidri, D.K, Karnataka - 574227
Dakshina Kannada
KARNATAKA |
8547223223
nayanabalan23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics committee, Alvas Ayurveda Medical College, Moodbidri, India |
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 | Comparator Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (Procedure Reference: Yogaratnakara, Procedure details: Twice per day)
(1) Medicine Name: Yashtimadhuka Rasakriya, Reference: Ashtangasamgraha, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(NA), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (Procedure Reference: Yogaratnakara, Procedure details: Twice daily)
(1) Medicine Name: Darvi rasakriya, Reference: Yogaratnakara, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(NA), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with signs and symptoms of Mukhapaka |
|
| ExclusionCriteria |
| Details |
Patients having chronic or carcinogenic ulcers in oral cavity
Patients who are known case of chronic systemic disorders and nutritional deficiencies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of the treatment will be assessed based on detailed case proforma adopting standard scoring methods of subjective parameters such as burning sensation, pain, difficulty in chewing and objective parameters such as size of ulcer, tenderness, number of ulcers. Pre and Post interventional assessment will be done |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised comparative clinical study to evaluate the efficacy of Darvi rasakriya pratisarana and Yashtimadhuka rasakriya pratisarana in Mukhapaka (Aphthous stomatitis) for a duration of 21 daysin 40 patients in OPD and IPD of PG studies in Shalakyatantra of Alva’s Ayurveda Medical College and hospital, Moodbidri, Vidyagiri, Dakshina Kannada, Karnataka, India. Assessment will be done based on detailed case proforma adopting standard scoring methods of subjective and objective parameters Pre and Post assessment will be done. Clinical symptoms will be graded and scores will be given accordingly |