| CTRI Number |
CTRI/2022/12/048112 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dashmooladi Tail gandush in dentin hypersensitivity |
|
Scientific Title of Study
|
Randomized open controlled clinical study to assess the effect of Dashmooladi taila gandusha dharan in dantaharsha
w.s.r.to dentin hypersensitivity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaitrali Dattatray Waghmode |
| Designation |
PG scholar |
| Affiliation |
muhs nashik |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur MAHARASHTRA 416114 India
Yashwant Ayurvedic Medical College PGT and RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7767871285 |
| Fax |
|
| Email |
waghmodechaitrali12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrasekhar mule |
| Designation |
PG Guide, Professor shalakyatantra department |
| Affiliation |
muhs nashik |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur MAHARASHTRA 416114 India
Yashwant Ayurvedic Medical College PGTand RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitrali Dattatray Waghmode |
| Designation |
PG scholar |
| Affiliation |
muhs nashik |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur MAHARASHTRA 416114 India
Yashwant Ayurvedic Medical College PGT and RC kodoli,shalakyatantra department OPD no 11,kodoli dist Kolhapur MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7767871285 |
| Fax |
|
| Email |
waghmodechaitrali12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical college PGT and RC kodoli dist kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Chaitrali Dattatray Waghmode |
| Address |
Yashwant Ayurvedic Hospital kodoli kolhapur |
| 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 |
| Chaitrali Dattatray Waghmode |
YASHWANT AYURVEDIC MEDICAL COLLEGE POST GRADUATION AND RESEARCH CENTRE |
SHALAKYATANTRA DEPARTMENT OPD NO 11 KODOLI
MAHARASHTRA
Kolhapur
MAHARASHTRA |
7767871285
waghmodechaitrali12@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 |
| Patients |
(1) ICD-10 Condition:K089||Disorder of teeth and supporting structures, unspecified. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | gaNDUShaH, गणà¥à¤¡à¥‚षः | (Procedure Reference: Yogratnakar , Procedure details: Dashmooladi tail gandush and irimedadi tail gandush in Dantharsh once a day as per capacity oral cavity (up to 100ml ))
(1) Medicine Name: Dashmooladi tail , Reference: Irimedadi tail, Route: Oral, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs and symptoms of dantharsha vadhi, irrespective of gender, religion, occupation socioeconomic status will be selected |
|
| ExclusionCriteria |
| Details |
Patient is suffering from other than dant harsha such as dental carries, gingivitis are excluded, traatic condition of oral cavity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain, hypersensitivity of tooth |
Decrease in pain, hypersensitivity of tooth in 2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of pain, hyper Sensitivity due to hot and cold food items |
18 months |
|
|
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)
|
25/12/2022 |
| 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="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
|
This study is a Randomized open controlled clinical study to access the effect of the dashmooladi taila gandush dharan in dant harsha w. S. R to dentin hypersensitivity. Study will be carried in opd of Shalakyatantra department of yashwant ayurvedic college and hospital kodoli. The observation should be drawn on the basis of symptoms after treatment given |