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CTRI Number  CTRI/2024/03/064421 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic treatment of swelling of gums with Priyangwadi Churna, Triphala Churna with or without Raktamokshana 
Scientific Title of Study   Efficacy of Priyangavadi Churna Pratisarana,Triphala Churna orally ,with or without Raktamokshana(Prachchana Vidhi) in the management of Shitada (Gingivitis) - an open labelled randomized comparative clinical trial  
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ganesh Dan 
Designation  M.S. Scholar 
Affiliation  ITRA Jamnagar 
Address  Department of Shalakya, fourth floor,institute building, ITRA Jamnagar,Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  9549721057  
Fax    
Email  ganeshdanc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D B Vaghela 
Designation  Professor , HOD 
Affiliation  Institute of Teachig and Research in Ayurveda, Jamnagar 
Address  4th floor, Department of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Jamnagar Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825407899  
Fax    
Email  drvaghela@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Ganesh Dan 
Designation  M.S. Scholar 
Affiliation  Institute of Teachig and Research in Ayurveda, Jamnagar 
Address  Department of Shalakya, fourth floor,institute building, ITRA Jamnagar,Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  9549721057  
Fax    
Email  ganeshdanc@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Institute of Teaching and Research in Ayurveda, Opp City B division Police station, Gurudwara road, Jamnagar, 361008, Gujarat, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NILL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Dan  Institute of Teaching and Research in Ayurveda Hospital  OPD No: 5, Dental, OPD of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Opposite to B division police station, Jamnagar 361008 Jamnagar GUJARAT
Jamnagar
GUJARAT 		 9549721057

ganeshdanc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research of Ayurveda Jamnagar   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
1Comparator ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रà (Procedure Reference: , Procedure details: )
2Intervention ArmDrugClassical(1) Medicine Name: Priyangavadi Churna, Reference: sushrut samhita chikitsa 22/12, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: Pratisaran with Honey
(2) Medicine Name: Triphala Churna, Reference: Sushruta samhita Sutra Sthana 38/56, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient of either sex aged between 18 to 60 years of age presenting with signs and symptoms of Shitada(Gingivitis) described as per Ayurveda and Modern Science will be included in the study.
2.The diagnosis of the disease shall be done with signs and symptoms of Shitada(Gingivitis)i.e.Akasmata Rakta Srava (Bleeding), Shotha(Inflammation), Krishnata(Discoloration of gums), Mukha Daurgandhya (Halitosis), Vedana (Pain), DantamamsaPrakledata(Moistness), Paka (Pus discharge) and DantamamsaMriduta (Sponginess).
3.Patients having minimum two clinical symptoms of Shitada will be included in the study.Primary symptom is Akasmata Rakta Srava (Bleeding) along with any other symptom of Shitada.
 
 
ExclusionCriteria 
Details  1.Patients below18 years and more than 60 years of age.
2.Patient with periodontal pocket with pus discharge.
3.Patients with evidence of malignancy, HIV and Diabetes Mellitus.
4.Any systemic disorder which may alter the result of the study i.e, Haemophilia or other bleeding disorders.
5.Pregnant women shall be excluded.
6.Patients who are using anticoagulant drugs like Aspirin etc. will be excluded.
7.The patients taking any other systemic drugs which can alter the result of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of intervention on signs and symptoms of Shitada (Gingivitis).  during the treatment period at baseline
4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the quality of life of the patient Assessment of recurrence of signs & symptoms of Shitada (Gingivitis) during follow up period  During follow up period on 15th & 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 14/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The trial is randomized clinical trial to evaluate the efficacy of Priyangvadi Churna Pratisarana, Triphala Churna orally with and without Raktamokshana (Prachchhana Vidhi) in the management of Shitada (Gingivitis). Total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer generated randomization. In the study Priyagvadi Churna Pratisaran 3gm. BD, Triphala Churna 5gm. HS orally will be given after meal with luke warm water for 1 month with Raktamokshana (Prachchhana Vidhi). In another group only Priyagvadi Churna Pratisaran 3gm. BD, Triphala Churna 5gm. HS orally will be given after meal with luke warm water for 1 month without Raktamokshana (Prachchhana Vidhi). Followup will be carried out at 15 days interval for 1 month on routine medicine.

 
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