| CTRI Number |
CTRI/2023/02/049797 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| 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
|
Clinical study of efficacy of Khadira Ghan Pratisarana with Gairika and Madhu in Pittaj Mukhpaka with special reference to Aphthous stomatitis in children†|
|
Scientific Title of Study
|
“A randomized, open labelled, controlled, clinical, study of efficacy of Khadira Ghan Pratisarana with Gairika and Madhu in pittaj mukhpaka with special referance to Aphthous stomatitis in childrens." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Prakash Patil |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and hospital Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and hospital Nanded Vajirabad Nanded MAHARASHTRA INDIA
Nanded
MAHARASHTRA
431601
India |
| Phone |
8421934166 |
| Fax |
|
| Email |
dikshapatil953@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini A Patil |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and hospital Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and hospital Nanded Vajirabad Nanded MAHARASHTRA INDIA
Nanded
MAHARASHTRA
431601
India |
| Phone |
9420247156 |
| Fax |
|
| Email |
organotech99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini A Patil |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and hospital Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and hospital Nanded Vajirabad Nanded MAHARASHTRA INDIA
Nanded
MAHARASHTRA
431601
India |
| Phone |
9420247156 |
| Fax |
|
| Email |
organotech99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurved college and hospital Nanded Vajirabad square Nanded Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Prakash Patil |
| Address |
Department Of Kaumarbhritya Government Ayurved College And Hospital Nanded Vajirabad Square Nanded MAHARASHTRA India |
| 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 |
| Dr Diksha Prakash Patil |
Government Ayurved College and Hospital Nanded |
Room no.02
Department of Kaumarbhritya
Nanded
MAHARASHTRA |
8421934166
dikshapatil953@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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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: Khadira Ghan Pratisarana with Gairika and Madhu, Reference: Astang hrdayam (Uttarsthana), Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 00(NA), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Choline Salicylate gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having Lakshan of Pittaj Mukhapaka (Aphthous Stomatitis) limited to buccal, labial mucosa and tongue.
2)Patients of age 1-10 years will be selected.
3)Patient will be selected irrespective of their gender, caste, religion, socioeconomic or educational status. |
|
| ExclusionCriteria |
| Details |
1) Patient having local lesions or deformity, for e.g.-Pyrorrhoea, Candidial ulcers, Oral thrush, herpetic ulcer, Tubercular ulcer/ syphilitic ulcers/Diabetic ulcers.
2) Patients suffering from uremic Stomatitis, allergic Stomatitis
3) Mukhpaka associated systemic disease, Immuno-suppressive disorders were excluded.
4) Patients having chronic and carcinogenic ulcer in oral cavity.
5) OSMF (Oral Submucosal fibrosis) |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Khadira Ghan Pratisarana with Gairika and Madhu in Pittaj Mukhapaka (Aphthous Stomatitis) in children
|
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the etiopathogenesis of Mukhapaka from Ayurvedic & contemporary medical literature.
2) To study the properties of Khadira Ghan Pratisarana with Gairika and Madhu from Ayurvedic texts.
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/02/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Randomized , Open labelled, Controlled, Clinical study of efficacy of KHADIRA GHAN PRATISARANA WITH GAIRIKA AND MADHU in Pittaj Mikhapaka locally on affected area three times a day for 07 Days and follow up on 3rd and 7th day.This study is conducted as PG course at single center. The primary outcome is to evaluate the efficacy of Khadira Ghan Pratisarana with Gairika and Madhu in Pittaj Mukhapaka (Aphthous Stomatitis) in children |