CTRI

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CTRI Number

CTRI/2020/04/024782 [Registered on: 22/04/2020] Trial Registered Prospectively

Last Modified On:

10/04/2020

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A clinical trial to study the effects of two drugs laksha powder application and tila yashtimadhu proven milk gargling in hypersensitivity of teeth

Scientific Title of Study

A comparative study to evaluate the efficacy of laksha choorna pratisarana and tila yashtimadhu siddha dugdha gandusha in dantaharsha

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ajindas v
Designation	MD Scholar
Affiliation	Alvas Ayurveda Medical College and Hospital
Address	Shalakya tantra Department 3rd floor Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	9844976119
Fax
Email	ajin.das.92@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Hemachandra shetty
Designation	Guide and Associate professor
Affiliation	Alvas Ayurveda Medical College and Hospital
Address	Shalakya tantra department 3rd floor Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	9632954244
Fax
Email	drhemachandra1985@gmail.com

Details of Contact Person
Public Query

Name	Dr Hemachandra shetty
Designation	Guide and Associate professor
Affiliation	Alvas Ayurveda Medical College and Hospital
Address	Shalakya tantra department 3rd floor Alvas Ayurveda Medical College and Hospital Moodbidri Dakshina Kannada KARNATAKA 574227 India
Phone	9632954244
Fax
Email	drhemachandra1985@gmail.com

Source of Monetary or Material Support

Shalakya tantra department 3rd floor Alvas Ayurveda Medical College and Hospital

Primary Sponsor

Name	Dr Ajindas v
Address	Koyilambath house Meppayur post Kozhikode dist pin 673524
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ajindas v	Alvas Ayurveda Medical College and Hospital	Shalakya opd Department of shalakya tantra room number 3 ground floor vidyagiri moodbidri DK District Karnataka 574227 Dakshina Kannada KARNATAKA	9844976119 ajin.das.92@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Clinical Ethical Committee Alvas Ayurveda Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, (1) ICD-10 Condition: K089\|\|Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K089\|\|Disorder of teeth and supporting structures, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Laksha choorna and Madhu Pratisarana	Quantity sufficient medicine to the affected tooth with the fingers Twice daily for 1 Week
Comparator Agent	Tila Yashtimadhu siddha dugdha Gandusha	Purva karma: Shoulder and neck should be massaged and fomented Pradhana karma: Gandusha dravya has to be kept till the mouth gets filled with kapha , grana srava, akshi srava.7 Paschat karma: The person is advised to do gargle with luke warm water, spit out and relax Quantity sufficient Twice daily for 1Week

Inclusion Criteria

Age From	13.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Patients with the age group of 13years and above. Dentine Hypersensitivity due to exposure of Dentine as a result of loss of enamel. Patients with pain, hypersensitivity towards cold, hot, sour substances.

ExclusionCriteria

Details

Patient having periodontal disorders like Dental carries, Gingivitis, Gingival Recession, Tooth mobility, bone loss.
Patient requiring surgical modalities such as root canal, pulpectomy.
Patient suffering from any other systemic disorder

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1. Pain 2. Hypersensitivity of teeth towards cold substances 3. Hypersensitivity of teeth towards hot substances 4. Hypersensitivity of teeth towards sour substances .Cold air blast test .Tactile test	21 days

Secondary Outcome

Outcome	TimePoints
Not applicable	Not applicable

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

01/05/2020

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)?

Brief Summary

This is randomised open label parallel group single centre trial comparing efficacy of laksha choorna pratisarana and Tila yastimadhu siddha dugdha Gandoosha for 7 days in 40 patients with Dantaharsha that will be conducted in Alva’s Ayurveda medical college Vidyagiri Moodbidri Dakshin Kannada India.Primary outcome measure will be relief from Pain ,Hypersensitivity of teeth towards cold substances,Hypersensitivity of teeth towards hot substances, Hypersensitivity of teeth towards sour substances in 21 days.