| CTRI Number |
CTRI/2024/03/063831 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect of Yashtimadhu decoction gargles and potassium nitrate along with sodium fluoride mouthwash in management of tooth hypersensitivity. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study efficacy of Yashtimadhu kwath Kaval with potassium nitrate plus sodium fluoride mouthwash in management of dantaharsha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha Ghatage |
| Designation |
MS Scholar Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveada Mahavidyalaya
Department of Shalakyatantra
2nd floor
583/2 Rasta Peth
Pune
583/2 Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9175046332 |
| Fax |
|
| Email |
meghaghatage1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Bhoi |
| Designation |
Associate Professor Shalakyatantra Department |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveada Mahavidyalaya
Department of Shalakyatantra
2nd floor
583/2 Rasta Peth
Pune
583/2 Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9823047544 |
| Fax |
|
| Email |
drmilindbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Ghatage |
| Designation |
MS Scholar Shalakyatantra |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveada Mahavidyalaya
Department of Shalakyatantra
2nd floor
583/2 Rasta Peth
Pune
583/2 Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9175046332 |
| Fax |
|
| Email |
meghaghatage1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya
583/2 Rasta Peth
Pune 411011 |
| 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 Megha Ghatage |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Department of Shalakyatantra
ENT OPD No 15
1st floor
Rasta Peth
Pune
Pune
MAHARASHTRA |
9175046332
meghaghatage1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K088||Other specified disorders of teethand supporting structures. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Astang Hridaya Sutrasthan 22/11, Procedure details: Kaval is a procedure of taking sufficient amount of medicated fluid in mouth such that the mouth can be moved is called as kaval.)
(1) Medicine Name: Yashtimadhu , Reference: Bhavprakash Sanhita , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Potassium nitrate with sodium fluoride mouthwash | Potassium nitrate with sodium fluoride mouthwash belongs to a class of oral and dental products primarily used to treat dental problems. It helps in tooth sensitivity by making it stronger and more resistant to decay caused by acid and bacteria. It is done by oral route and 2 to 3 times daily for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from dantaharsha
Patients ready to give written consent for study trial.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from tuberculosis, HIV, HErpes zooster infection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sample size 60 decrease in Pain at affected teeth, hypersensitivity to cold, hypersensitivity to hot and sour food. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sample size 60 decrease in Pain at affected teeth, hypersensitivity to cold, hypersensitivity to hot and sour food in 3 months. |
3 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 3 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be intervened by treatment of yashtimadhu kwath kaval with potassium nitrate and sodium flouride mouthwash to group A and group B respectively. The efficacy of therapy will be assessed on the basis of subjective criteria for statistical analysis. scoring will be designed according to the severity of symptoms. the subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after followup. The effect of treatment results will be assessed in regards to the clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |