| CTRI Number |
CTRI/2022/11/047507 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to study effect of shunthi dadimtwak choorna pratisaran (massage on teeths and gums )in the treatment of sheetdanta (cold hypersensitivity of teeth) |
|
Scientific Title of Study
|
A clinical study to explore efficacy of shunthi dadimtwak choorna pratisaran in the sheetdanta. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Vitthal Kamthe |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
9175708637 |
| Fax |
|
| Email |
kamtheamruta577@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Darunde |
| Designation |
Assistant professor shalakyatantra department |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India |
| Phone |
8983088238 |
| Fax |
|
| Email |
swd420@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Kamthe |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra 411044 India
Pune
MAHARASHTRA
412301
India |
| Phone |
9175708637 |
| Fax |
|
| Email |
kamtheamruta577@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs ayurved college and research centre sector no. 25 pradhikaran nigdi pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune |
| 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 |
| Dr Amruta Vitthal Kamthe |
Ayurved rugnalay and sterling multispeciality hospital, nigdi,pune |
sector no. 27 shalakya OPD no. 122 nigdi pradhikaran pune 411044
Pune
MAHARASHTRA |
9175708637
kamtheamruta577@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
person having symptoms of mid to moderate sheet dant (cold hyper sensitivity of teeths and gums) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (Procedure Reference: Wagbhat Uttartantra 21/11,12, Procedure details: the patient will be asked to keep his face slightly up and advised to rub the churn to the dentin and gums for 5 minutes 2 times a day for 15 days)
(1) Medicine Name: suthi dadimtwak churn, Reference: wagbhat uttartantra 21/11,12, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Feature of Sheetdant namely-
Incapability of teeth to tolerate cold.
toothache
|
|
| ExclusionCriteria |
| Details |
1.Patient in age group below 20 & above 60.
2.Traumatic conditions of the oral cavity.
3.Any acute infective condition of the oral cavity, patients having periodontal disorders like gingivitis, gingival recession, tooth mobility and patient requiring surgical modalities such root canal, pulpectomy will be excluded from.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-to identify efficacy of shunthi dadimtwak churna pratisaran in the management of sheetdant.
-to relieve symptoms of sheetdant like incapability of teeth to tolerate cold and toothache
|
total 15 days with 2 follow ups on 7th and 14th. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-to assess the efficacy of shunthi dadimtwak pratisaran in the management of sheetdant in 15 days
-to assess the adverse effect of treatment if any.
-to relieve intolerance to cold up to 10 days
-to relieve toothache upto 15 days |
15 days treatment with 2 follow ups 7th and 14th day. |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
25/11/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ayurveda described ashtang ayurved in which shalakyatantra is one of the most important branch.shalakyatantra gives detail information about diseases in ear nose throat oral route( including teeth and gums) eyes, etc. sheetdant is one among the dantarogas clinically sheetadanta shows similarities with tooth pain in cold sensitivity. lack of oral hygiene, tooth grinding, habitual ingestion of acidic substances causes erosion of enamel dentine those who use tobacco increases intra oral acidity and causes erosion of enamel.sheetdant is associated with odontalgia hypersensitivity to cold water, air and loosening of teeth. many remedies are prescribed in modern medicine for the treatment of odontalgia.but these methods are quite costly and causing lot of inconvenience to patients. hence it is relevant to develope an easy and economic ayurvedic medical measures.shunthi dadimtwak churna pratisaran selected for the reference taken from vagbhata sanhita. in the present study selection of topic to work on sheetdant to assess the curative effect of shunthi dadimtwak pratisaran. |