CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 18:54:38 GMT)

CTRI Number CTRI/2019/09/021139 [Registered on: 09/09/2019] - Trial Registered Prospectively Last Modified On 07/09/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Ayurveda Study Design Single Arm Trial Public Title of Study Sapthachada Kshara pratisarana in Dental Plaque Scientific Title of Effectiveness of Sapthachada Kshara in Dental Plaque Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Mira Krishnan M Trial Coordinator (multi-center study) Designation PG Scholar Affiliation Amrita School of Ayurveda Address Department of Salakyatantra Amrita school of ayurveda Vallikavu Clappana P O Kollam Kollam KERALA 690525 India Phone 7736853957 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ashwini B N Query) Designation Associate Professor Affiliation Amrita School of Ayurveda Address Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kollam KERALA 690525 India Phone 7025867095 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ashwini B N Designation Associate Professor Affiliation Amrita School of Ayurveda Address Department of Salakyatantra Amrita School of Ayurveda Clappana P O Kollam Kollam KERALA 690525 India

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Phone 7025867095 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Amrita school of ayurveda Vallikavu Clappana P O Kollam 690525 Primary Sponsor Primary Sponsor Details Name Amrita School of Ayurveda Address Amrita school of ayurveda Vallikavu Clappana P O Kollam 690525 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Mira Krishnan Amrita School of Salakyatantra OPD 7736853957 Ayurveda Department of Salakyatantra Amrita [email protected] school of ayurveda Vallikavu Clappana P O Kollam 690525 Kollam KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 04/01/2019 No Committee AMRITA INSTITUTE OF MEDICAL SCIENCES and RC KOCHI Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Other specified bacterial diseases Intervention / Type Name Details Comparator Agent Intervention Saptachada kshara pratisarana Patient is asked to rub 250 mg with honey Tila yashtimadhu kshara with 4 drops of honey ksheera gandusa over the teeth for 2 minutes once daily and 100 ml of tila yashti ksheera is given for gandusa and asked to hold in mouth for 5 minutes This is continued for 30 days Comparator Agent 0 0 Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 50.00 Year(s) Gender Both Details Fulfilling subjective and objective parameters
Chronicity less than 5 years
Without any systemic involvement like Type 2

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diabetes cardiovascular kidney disorders Artherosclerosis
No long term medications like Antibiotics or steroids
5 Patients indicated for kshara karma
Age20 to 50 yrs of either sex Exclusion Criteria Exclusion Criteria Details Dental hygiene appointment in the past 6 months Use of antibiotic or steroids in the past 3 months Presence of extensive caries and fractures of teeth History of allergies to oral care or their ingredients Pregnant women or women who are breastfeeding Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Plaque index 45 days Gingival bleeding index Secondary Outcome Outcome Timepoints Teeth discoloration 45 days Teeth sensitivity Halitosis Dryness of mouth Target Sample Size Total Sample Size=30 Sample Size from India=30 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 10/09/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None yet Brief Summary RATIONALE Dental plaque is a structurally and functionally organised biofilm . It is the aetiological agent for dental diseases such as dental caries and periodontal diseases. A cleaned tooth surface immediately comes into contact with bacterial and host products in saliva and gingival crevicular fluid. If dental plaque is left undisturbed for 7 days , the local environment rapidly changes, favouring bacterial colonisation. In India, there are more than 10 million cases per year . Standard treatment techniques are Scaling, root planning and flossing . Scaling can raise concerns for individuals in diabetic condition, Heart problem and in non-ambulated patients. Scaling has limitations like sensitivity to hot and cold. Flossing creates gap between teeth. Chlorhexidine mouth rinse can cause allergic reactions. Frequent hospital visit is a burden for the society.

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To overcome these limitations, there is a need for an alternative treatment modality. Hence the present treatment is proposed.

STUDY DESIGN – Pre and post test study of sample size 30 and duration 30 days. Paired t test will be used for statistical analysis. expected expenditure Rs 8000.

METHOD - Patient is asked to use 250 mg kshara with 4 drops of honey as pratisarana followed by Tila yashtimadhu ksheera gandusa dharana for 5 minutes for a duration of 30 days.

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