| CTRI Number |
CTRI/2025/03/082873 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Dashmoola kwath Kavala In Dantaharsha with special reference to Dentine Hypersensitivity |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Dashmoola Kwath Kaval in Dantaharsha with special reference to Dentine Hypersensitivity. |
| 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 Yede |
| Designation |
MS Scholar Shalakyatanta (Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College, Sangli Islampur ,Maharashtra |
| Address |
Department of shalakyatantra Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8928831105 |
| Fax |
|
| Email |
msdhonimegha7781@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Pravin Chavan |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic Medical College, Sangl |
| Address |
Department of shalakyatantra Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822338613 |
| Fax |
|
| Email |
drpravin999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Pravin Chavan |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic Medical College, Sangl |
| Address |
Department of shalakyatantra Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822338613 |
| Fax |
|
| Email |
drpravin999@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical college ,Islampur,District Sangli Maharashtra India 415409
|
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Medical College and research institute islampur |
| Address |
Department of shalakyatantra Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra India 415409 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrMegha Yede |
LRP Ayurvedic Medical college ,Islampur |
Department of Shalakya Tantra ,Unit 1,LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre ,Islampur Sangli ,Maharashtra 425409
Sangli
MAHARASHTRA |
8928831105
msdhonimegha7781@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:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: DANTAHARSHAH, (2) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Sensodyne Mouth wash | sensodyne mouth wash once a day at morning will be done for 15 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoola kwath kawal , Reference: Shushruta chikitsa sthan , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Dashmoola kwath kawal , Reference: Shushruta chikitsa sthan , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptoms of dantaharsha
2.Patients between 5-70 age group
3.irrespective of gender ,caste,economical class, |
|
| ExclusionCriteria |
| Details |
1. Patients having dantaharsha with other oral problems like mouth ulcers ,etc.
2.patients below 5 and above 70 of age
3. Patients having systemic disease with complication which can lead to interference with the study .
4. Mentally Retarded patients
5. Congenital anomalies of the teeth like Anodontia, Ectodermal Dyplasia ,etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the efficacy of dashmoola kwath kavala in the management of Dantaharsha with special reference to dentin hypersensitivity . |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the conceptual literature of Dantaharsha in detail.
To study the conceptual literature of dentine hypersensitivity in detail.
Preparation of dashmoola kwath
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/03/2025 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dantaharsha is one of the 8 dantaroga explained by Acharya Shushruta and it is the most common disorder of teeth.[2] Clinically if teeth do not tolerate cold or hot or sweet or other kind of touch it is known as Dantaharsha.[3] It can be compared with dental hypersensitivity. Dantagatarogas, it’s causes, prevention and treatment are explained in detail in all the ancient texts of Ayurveda. This shows the importance given to oral health. Medicine for treatment of dentine hypersensitivity like use of fluorides oxalate etc are prescribed in Modern science in the form of paste, lasers etc. But these methods are quite expensive and often recurrence of the symptoms is seen. Long use of these fluorides and Oxalate like chemicals causes allergic reaction to gums. So it becomes must to develop an easy, economic and non-toxic treatment of dantaharsha
Kavala is one of the effective methods described in daily regimens to be followed in a healthy individual. Shushrutaacharya has described Kavala of vatahar dravya koshna kwath in the management of Dantaharsha in Chikitsasthana chapter 22 so we have decided to take DashmoolKwath as vatahar dravya kwath in this clinical study.
To Study the efficacy of Dashmoola Kwath Kavala in the management of Dantaharsha with special reference to Dentin Hypersensitivity.
|