| CTRI Number |
CTRI/2020/12/029467 [Registered on: 01/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Yashtimadhu Sidhha Payah(milk) Kavala(gargles) and Babul Twak Kwath Kavala(gargles) in Pittaj Mukhapaka(stomatitis). |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE EFFICACY OF YASHTIMADHU SIDHHA PAYAH KAVALA WITH BABUL TWAK KWATH KAVALA IN PITTAJ MUKHAPAKA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Toshika Yashwant Bhortakke |
| Designation |
PG Student |
| Affiliation |
PDEAs College Of Ayurved And Research Centre Nigdi, Pune. |
| Address |
Department of Shalakya tantra,PDEAs College Of Ayurved And Research Centre Akurdi, Sect. No. 25 Pune. Ayurved Rugnalaya And Sterling Multispeciality Hospital Sect. no. 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8208823121 |
| Fax |
|
| Email |
toshbhortake5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha P Pingale |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre Pune. |
| Address |
Department Of Shalakyatantra, OPD no.122A,PDEAs College Of Ayurved And Research Centre Akurdi Sect.25 Pune Ayurved Rugnalaya And Sterling Multispeciality Hospital Sect. 27,Nigdi Pradhikaran,Pune 44.
Pune
MAHARASHTRA
411044
India |
| Phone |
9850160353 |
| Fax |
|
| Email |
manishapingale999@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Toshika Yashwant Bhortakke |
| Designation |
PG Student |
| Affiliation |
PDEAs College Of Ayurved And Research Centre Nigdi, Pune. |
| Address |
Department of Shalakya tantra,PDEAs College Of Ayurved And Research Centre Akurdi, Sect. No. 25 Pune. Ayurved Rugnalaya And Sterling Multispeciality Hospital Sect. no. 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
8208823121 |
| Fax |
|
| Email |
toshbhortake5@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre 3rd floor Shalakyatantra Department Akurdi Pune. Nigdi Pradhikaran Sector 25, Pune 44. |
|
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Primary Sponsor
|
| Name |
Principal PDEAs College Of Ayurved And Research Centre |
| Address |
PDEAs College Of Ayurveda And Research Centre, Sector no. 25 Nigdi Pradhikaran ,Pune 44.
|
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Toshika YashwantBhortakke |
Ayurved Rugnalaya and Sterling Multispeciality Hospital,Nigdi Pradhikaran Pune. |
Vithhal Rukmini road, sect no.27, Shalakyatantra Department - OPD no.122A , Nigdi Pradhikaran, Pune 44. Pune MAHARASHTRA
Pune
MAHARASHTRA |
8208823121
toshbhortake5@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Babul Twak Kwath Kavala. |
Group B will be treated with Babul Twak Kwath Kavala containing Babul twak choorna and water.Babul Twak Kwath Kavala orally (lukewarm) given to the patient for 3to 4 times gargle and rinse the mouth to its full capacity.It is given once a day for total 10 days in age group of 18-60yrs. whitch includes follow up on 5th and 10th day. |
| Intervention |
Yahtimadhu Sidhha Payah Kavala. |
Group A will be treated with Yashtimadhu Sidhha Payah Kavala containing Yashtimadhu and Godugdha.Yashtimadhu Sidhha Payah Kavala orally (lukewarm) given to the patient for 3 to 4 times gargle and rinse the mouth to its full capacity.It is given once a day for total 10 days, in age group of 18-60yrs. whitch includes follow up on 5th and 10th day. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical sign and symptoms of mukhapaka, like asyavrana, asyaruja, asyadaha, asyavairasyata, jivhasfutan, salivation, difficulty in diglutition.
2. age between 18-60years.
3. recurrent oral ulcer with symptoms of mukhapaka. |
|
| ExclusionCriteria |
| Details |
1. Agantuja Mukhapaka(like traumatic etc.)
2. Patients recently undergone oral surgeries (history of surgery done in last 1 year).
3. Infective stomatitis.
4. Allergic stomatitis.
5. Mukhapaka associated with systemic disease eg. Haematological disease, gastrointestinaltrack diseases , bahcet’s disease, HIV, diabetic ulcer, etc.
6. Major aphthous ulcer, herpatic from ulcer.
7. Dermatological disease like vesiculloballous disease.
8. Neoplastic squamous cell carcinoma, other malignant carcinoma
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of yashtimadhu sidhha payah kavala(lukewarm) for gargle and rince the mouth to its full capacity and babul twak kwath kavala (lukewarm) for gargle and rince the mouth to its full capacity, once a day for 10 days in pittaj mukhapaka. |
10 days with follow up on 5th and 10th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to compare and study the efficacy of yashtimadhu sidhha payah kavala.
2. to compare and study the efficacy of babul twak kwath kavala in pittaj mukhapaka.
3. to study the adverse effect , if any. |
10 days with follow up on 5th and 10th day. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
mukhapaka is pitta nanatmaja and rakta pradoshaj vyadhi. it is characterised by vedanayukta vrana commonly. in ancient text books cause of disease is given as poor oral hygeinic conditions , mixed food habbituals, rakta pradoshak aahar and vihar. Due to changed life style all these reason we can see in daily routine of most of the people , like pooor oral hygeinic conditions due to no tooth brush use , use of mishri, habbits like aireted drinks , smoking cigarettes, tobacco chewing , also we can see change in day today time table of maximum people like awaking in night, sleeping in day time after meal, no exercise, food made with mchemicals, work in excessive heat or cold, increased use of air conditioners, mainly mixed type of food eating , acidic food which eventually leads to aggrevation of causitive factors for mukhapaka. Mukhapaka like signs and symptoms are sen in recurrent mouth ulcer or stomatitis. as per study from nov 2020 to dec 2012 , 21.7% patients were suffering from recurrent apthous ulcer having mukhapaka like sign and symptoms. In ayurveda ancient text books given all information about mukhapaka disease. caused , sign symptoms, prevention care and treatmenet , etc. India is tropical country having harsh hot, humid climate. as per(ncbi.nim.nih) incidence rate is of 20%, which is quit high. most of people neglect causes and disease to which leads to major complication . so it’s need of now a days to find easiest, affordable and ancient technique of treatment for majority of people. Ayurvedic text having many medicined kalpana’s are given , among those kavala . pratisaran , alepan are apllied mostly to mukhapaka. In this kavala kalpana , as perAshtang sangraha adhyay 26/178 , treatment of madhurgan sidhha payah kavala is given. it is applied here. In madhurgan yashtimadhu is one drug which is used in vrana chikitsa and it is included in madhurgana also, also seeing its availability it is easily available. So, to prevent further complication and treat disease in easiest simple , affordable way yashtimadhusidhhapayah kavala is selected. compairing yashtimadhu sidhha payah kavala with babul twak kwath kaval will give its efficacy. |