| CTRI Number |
CTRI/2023/10/058931 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Ela Churna (Elettaria
Cardamomum) Pratisarana with Madhu in Vataja Mukhapaka
w.s.r. Aphthous stomatitis |
|
Scientific Title of Study
|
Randomized Controlled clinical trial of the efficacy of Ela Churna (Elettaria
Cardamomum) Pratisarana with Madhu in the management of Vataja Mukhapaka
w.s.r. Aphthous 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 |
SHINDE POOJA SUNIL |
| Designation |
PG SCHOLAR |
| Affiliation |
SANGAM SEVA BHAVI TRUST AYURVEDIC MAHAVIDYALAYA GRADUATE AND RESEARCH CENTRE |
| Address |
OPP PRASAD HOTEL PUNE NASHIK HIGHWAY GHULEWADI SANGAMNER
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7058905090 |
| Fax |
|
| Email |
poojasshinde3107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD JORI REKHA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SANGAM SEVA BHAVI TRUST AYURVEDIC MAHAVIDYALAYA GRADUATE AND RESEARCH CENTRE |
| Address |
OPP PRASAD HOTEL PUNE NASHIK HIGHWAY GHULEWADI SANGAMNER
OPP PRASAD HOTEL PUNE NASHIK HIGHWAY GHULEWADI SANGAMNER
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9503197787 |
| Fax |
|
| Email |
drrekhamatkar1912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHINDE POOJA SUNIL |
| Designation |
BAMS SCHOLAR |
| Affiliation |
SANGAM SEVA BHAVI TRUST AYURVEDIC MAHAVIDYALAYA GRADUATE AND RESEARCH CENTRE |
| Address |
OPP PRASAD HOTEL PUNE NASHIK HIGHWAY GHULEWADI SANGAMNER
OPP PRASAD HOTEL PUNE NASHIK HIGHWAY GHULEWADI SANGAMNER
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7058905090 |
| Fax |
|
| Email |
poojasshinde3107@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya Graduate & Research Centre Sangamner |
|
|
Primary Sponsor
|
| Name |
Ayurveda Mahavidyalaya Graduate Research Centre |
| Address |
Ayurveda Mahavidyalaya Graduate & Research Centre Opp Prasad Hotel , Nashik Pune Highway Ghulewadi Sangamner |
| 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 |
| Vd Shinde Pooja Sunil |
Ayurveda Mahavidyalaya Graduate & Research Centre |
OPD and IPD of Shalakyatantra department Ayurveda Mahavidyalaya Graduate & Research Centre
Ahmadnagar
MAHARASHTRA |
7058905090
poojasshinde3107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K121||Other forms of stomatitis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala churna, Reference: Cha Chi 26/205, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ela churna, Reference: Cha Chi 26/205, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)PATIENT WILLING TO SIGN WRITTEN CONSENT
2)PATIENT WITH SYMPTOMS OF VATAJA MUKHAPAK i.e. SHUSHKA VRANA IN MOUTH , TAMRA VRANA AT LIP , VEDANA , SHEET SPARSHASAHATVA OF JIVHA
3)IRRESPECTIVE WITH SEX , RELIGION, OCCUPATION |
|
| ExclusionCriteria |
| Details |
1.Patient with symptoms Pittaj & Kaphaj Mukhapak like Daha, kandu, Vrana Pichhil vrana or ksharokshat Vrana.
2.K/C/O CA Oral cavity, Syphilis, AIDS, Herpes, Dengue hemorrhagic fever, DM, HTN.
3.K/C/O Traumatic stomatitis, Drug induced stomatitis
4.Lactating & pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate & document the efficacy of Ela churna (Elettaria Cardamomum) pratisarana with madhu in the management of Vataja Mukhapak w.s.r Apthous stomatitis. |
Assessments will be 1st 7th 14 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observed & document the efficacy of Ela churna (Elettaria Cardamomum) pratisarana with madhu in the management of Vataja Mukhapak w.s.r Apthous stomatitis. |
Assessments will be 1st 7th 14 Day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2023 |
| 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="1"
Months="0"
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
|
The current study aimed as randomized control parallel group trial efficacy of Ela Churna (Eletaria cardamomum) Pratisarana with Madhu in the management of Vataja
Mukhapaka w.s.r. Aphthous stomatitis.Total 80 diagnosed patients of Vataja Mukhapaka are equally divided into two groups.The symptoms of Mukhapaka Vrana, Tamra & Ruksha Oshta , Jivha Sheet Sparshasahatva. pratisarana Ela Churna with madhu 10 gms used as Experimental group medicine for ones a day for 14 days and pratisaranaTriphala churna with madhu 10 mg used as control group medicine once a day for 14 days duration. Assessment will be done on the 1st 7th and 14th day. As Mukhrogas are due to improper food, consumption of hot and spicy
food i.e. Ahita Ahar ; improper life style i.e. Ahita
Vihar causes Mukhroga (Mukhpaka). Ayurvedic Medicine is
very much helpful to break pathogenesis with relief of sign and symptom.The
symptoms of Vataja Mukhapaka can be correlated with Apthous stomatitis.
Also ela
and triphala are used in the
management of Vataja mukhapaka.Ela churna((Eletaria cardamomum) had laghu guna ,vataghna property & due to its snightava guna it is very
much effective in Vataja mukhapaka. Gradually preventing complication in the reference of Ela churna (Eletaria cardamomum) is one of the drug mentioned for its effectiveness in Mukhapaka & which is easily available and cost effective |