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CTRI Number  CTRI/2022/07/044338 [Registered on: 26/07/2022] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “To evaluate the effect of local application with Yavakshara churna and Madhu as wound healer after scaling of teeth in dental tartar”  
Scientific Title of Study   “To evaluate the effect of Pratisarana with Yavakshara churna and Madhu as vrana ropaka after removal of Danta sharkara (Dental tartar)”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mridulata maurya 
Designation  Assistant Professor 
Affiliation  BHU, Varanasi 
Address  Shalakya tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9456914468  
Fax    
Email  mridulata@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Bijoyanand mukhopadhyaya 
Designation  Professor and HOD 
Affiliation  BHU, Varanasi 
Address  Shalakya tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7905827622  
Fax    
Email  bijoyananda@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Mridulata maurya 
Designation  Assistant Professor 
Affiliation  BHU, Varanasi 
Address  Shalakya tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9456914468  
Fax    
Email  mridulata@bhu.ac.in  
 
Source of Monetary or Material Support  
Ayurveda and Dental wing, Sir sunder lal hospital, IMS, BHU and Shalakya tantra department, Faculty of Ayurveda, IMS, BHU, Varanasi 
 
Primary Sponsor
Modification(s)  
Name  Prof KNDwivedi 
Address  Dean, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof K S Dhiman  Shalakya tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi 
Prof Rajesh bansal  Department of Prosthodontics, Faculty of dental, Institute of Medical Sciences, Banaras Hindu University, Varanasi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mridulata maurya  Banaras Hindu University, Varanasi  Mukha evum danta roga OPD, Near female KC ward, Ayurveda wing, Sir Sunderlal Hospital, IMS, BHU, Varanasi
Varanasi
UTTAR PRADESH 		 9456914468

mridulata@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee, IMS, BHU, Varanasi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTASARKARA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Chlorhexidine gluconateAfter scaling of all teeth, 35 patients of group B will be advised to brush teeth gently with Hexigel (chlorhexidine gluconate) gel on scaling wound from the next morning twice a day for 7 days
2Intervention ArmDrugClassical(1) Medicine Name: Yavakshara churna , Reference: Astang hridaya uttar sthana 22/17, Route: Topical, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: After scaling of all teeth, 35 patients will be advised to brush teeth gently with Yavakshara churna (an alkali preparation from the plant Hordeolum barley) and madhu (honey) paste on scaling wound from the next morning twice a day for 7 days
(2) Medicine Name: Madhu, Reference: Astang hridaya uttar sthana 22/17, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: After scaling of all teeth, 35 patients will be advise
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18-60 yrs of both sexes
Patients having sign and symptoms along with dental tartar deposit 
 
ExclusionCriteria 
Details  Patients taking antibiotics, NSAIDs and steroids in last 3 months
Patients who are pregnant and lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical observations will be recorded in tabular form. The subjective and objective parameters of both groups will be evaluated on indexed tooth 16,36,11, 31,22,44 as follow  Clinical parameters 1st day after teeth scaling 3rd day 7th day 15th day
1. Tartar index (TI)
2. Gingival index (GI)
3. Sensitivity index (SI)
4. Pocket depth (PD)
5. Halitosis index (HI)
 
 
Secondary Outcome  
Outcome  TimePoints 
To see the clinical safety of the Yavakshara churna and madhu pratisarana as well as effect of Yavakshara churna and madhu on gum injury caused by scaling of teeth.  After observation, data will be presented in various groups. Data will be applied for statistical analysis and result will be assessed. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/07/2022 
Date of Study Completion (India) 07/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 “A case report on effect of Yavakshara powder and honey in dental tartar disease” by Dr Mridulata Maurya, Prof B Mukhopadhyay, Prof Rajesh Bansal in “World Journal of Pharmacy and Pharmaceutical Sciences” Journal in Volume 12, Issue 12, Pg 1051-1058, December 2023, SJIF Impact factor 7.632, ICV 84.65, (ISSN 2278-4357) [ DOI : 10.20959/wjpps202312-26193 ] “Standardization of yavakshara churna and madhu on scaling wound- A drug review” by Dr Mridulata Maurya, Prof B Mukhopadhyay, Prof Rajesh Bansal in “World Journal of Pharmaceutical research” Journal in Volume 12, Issue 21, Pg 292-304, December 2023, SJIF Impact factor 8.084, ICV 90.8, (ISSN 2277-7105) [ DOI :10.20959/wjpr202321-30389 ]  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Patients with dental tartar who met the inclusion and exclusion criteria were registered after getting informed written consent. The 70 registered cases were randomly allocated into trial and control groups using random allocation sequence. All the patients were advised to apply drug on scaling wound from the next morning. In Group A, patients were advised to apply Yavakshara churna (250mg) and Madhu (1/2 tsf) paste on teeth and gums twice a day for 7 days, whereas in Group B, patients were advised to apply Hexigel (chlorhexidine gluconate) oral gel on teeth and gums twice a day for 7 days. The clinical parameters (Tartar index, Gingival index, Sensitivity index, Pocket depth, and Halitosis index) were observed on 1st, 3rd, and 7th day during the period of treatment. The clinical parameters were observed on 15th day under the follow-up to check for any recurrence/ progression/ adverse effects of any drugs used. 

 
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