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CTRI Number  CTRI/2025/08/092133 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparitive effect of Tejovatyadi and Priyangvadi powder application with Nagaradi kashaya holding in mouth in gingivitis  
Scientific Title of Study   A Randomised Open Label Comparitive Clinical Study To Evaluate The Efficacy Of Tejovatyadi Churna Pratisarana Followed By Nagaradi Gandusha And Priyangvadi Churna Pratisarana Followed By Nagaradi Gandusha In Sheetada W S R To Gingivitis 
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 Sabihabanu M Shaikh 
Designation  Pg Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 
Address  OPD No 21 Department of Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 10 Pipeline Road RPC Layout Vijayanagar Bangalore Karnataka 560104

Bangalore
KARNATAKA
560104
India 
Phone  8431854333  
Fax    
Email  sabihashaikh963@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena shekar 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 
Address  Department of Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 10 Pipeline Road RPC Layout Vijayanagar Bangalore Karnataka 560104

Bangalore
KARNATAKA
560104
India 
Phone  9242314631  
Fax    
Email  ven280005@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena shekar 
Designation  Professor 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 
Address  Department of Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre 10 Pipeline Road RPC Layout Vijayanagar Bangalore Karnataka 560104

Bangalore
KARNATAKA
560104
India 
Phone  9242314631  
Fax    
Email  ven280005@gmail.com  
 
Source of Monetary or Material Support  
Dr Sabihabanu M Shaikh Room No 21 Dept Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 
 
Primary Sponsor  
Name  Dr Sabihabanu M shaikh 
Address  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Banglore 10 Pipeline RPC Layout Vijayanagar Bangalore Karnataka 560104 
Type of Sponsor  Other [Dr Sabihabanu M shaikh] 
 
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 kiran m goud  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre   Room No 21 Dept Of Pg Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA 		 98451 09556

Kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMC AND RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: SITADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: ASHTANGA HRUDAYA , Procedure details: Quantity Sufficient to restrict movement of fluid in oral cavity. (40-80ml) Twice a day for 2-6 min. )
(1) Medicine Name: TEJOVATYADI CHURNA, Reference: ASHTANGA SANGRAHA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 7 Days
(2) Medicine Name: NAGARADI GANDUSHA, Reference: YOGARATNAKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 40(ml), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: ASHTANGA SANGRAHA, Procedure details: Quantity Sufficient to restrict movement of fluid in oral cavitY 40 ml Twice a day for 2-6 min )
(1) Medicine Name: PRIYANGVADI CHURNA, Reference: SUSHRUTA SAMHITA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 7 Days
(2) Medicine Name: NAGARADI GANDUSHA, Reference: YOGARATNAKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 40(ml), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with the clinical features of Sheetada
Subjects presenting with signs and symptoms of Gingivitis  
 
ExclusionCriteria 
Details  Subjects with Periodontal pockets with pus discharge
Subjects diagnosed with malignancy HIV and a history of metabolic disorders like Diabetes
mellitus and thyroid disorders
Subjects with a history of bleeding disorders.
Subjects who are using anticoagulant drugs like Aspirin
Subjects who are diagnosed with Ascorbic acid Deficiency Gingivitis
Subjects diagnosed with Autoimmune disorders like Systemic lupus erythematosus
Sjögrens syndrome and Mucous membrane pemphigus vulgaris
Pregnant and lactating women  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to asses the reduction in aksamath rakta srava krushnata dantamamsaprakledata shotha mukhadourgandhya by gingival index and other parameters in two treatment modalities viz tejovatyadi churna pratisarana foloowed by nagaradi gandusha and priyangvadi churna pratisarana followed by nagaradi gandusha in sheetada   2 years 
 
Secondary Outcome  
Outcome  TimePoints 
nil  NA 
 
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 
Date of First Enrollment (India)   18/05/2026 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Sheetada, a condition described in Ayurvedic literature is characterized by symptoms such as spontaneous bleeding of the gums swelling foul breath  and discoloration of the gingiva These clinical features closely resemble those of Gingivitis in modern dentistry  Ayurveda prescribes several therapeutic procedures for the management of Sheetada including Gandusha (medicated gargling) and Pratisarana (local application or rubbing of medicated powders or pastes) which aim to disrupt the pathogenesis of the disease and promote gingival health

Among the formulations Tejovatyadi Churna Pratisarana followed by Nagaradi Gandusha and Priyangvadi Churna Pratisarana followed by Nagaradi Gandusha, are specifically mentioned in classical Ayurvedic texts as effective treatments for Sheetada

 
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