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CTRI Number  CTRI/2025/11/097559 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to Compare the Effectiveness of Scaling with Ayurvedic Formulations in Managing Periodontitis (Upakusha) 
Scientific Title of Study   A Randomised comparative clinical trial to evaluate the efficacy of scaling followed by pratisarana with dasanasamskara churna ,laxadi churna and yastimadhu ghrita kavala in the management of upakusha (periodontitis). 
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 Guruswamy M K 
Designation  PhD Scholar 
Affiliation  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital Nadiad,Gujarat. 
Address  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital. Room no 135 Ground floor ,Department of Shalakya tantra Nadiad,Gujarat.

Kheda
GUJARAT
387001
India 
Phone  08722258721  
Fax    
Email  guruswamygs2097@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganga R Hadimani 
Designation  Professor and HOD 
Affiliation  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital. 
Address  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital. Room no 135 Ground floor ,Department of Shalakya tantra Nadiad,Gujarat.

Kheda
GUJARAT
387001
India 
Phone  8780067570  
Fax    
Email  gangupatil2001@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganga R Hadimani 
Designation  Professor and HOD 
Affiliation  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital. 
Address  J S Ayurveda mahavidyalaya and P D Patel Ayurveda Hospital. Room no 135 Ground floor ,Department of Shalakya tantra Nadiad,Gujarat.

Kheda
GUJARAT
387001
India 
Phone  8780067570  
Fax    
Email  gangupatil2001@rediffmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Guruswamy M K 
Address  Department of shalakya tantra J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital, Room No 135,Ground floor department of shalakya tantra J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital Nadiad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nill  Nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Guruswamy M K  J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital  Room no 135 ,Department of shalakya tantra J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital, Room No 135,Ground floor department of shalakya tantra J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital Nadiad
Kheda
GUJARAT 
08722258721

guruswamygs2097@gmail.com 
DrGuruswamy M K  Shri Kalidas Ayurvedic Medical College and Hospital   Room no 12 ,Department of Shalakya Tantra ,,Shri Kalidas Ayurvedic Medical College and Hospital Badami,tq-Badami,Dist-Bagalkot-587201
Bagalkot
KARNATAKA 
08722258721

guruswamygs2097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee for Human research  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: UPAKUSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: dasana samskara churna , Reference: Dasji Govinda, Bhaishajya Ratnavali, Commentary by Shashtri Kaviraja Ambikadatta Published by Chaukambha Sanskrit Samstana Varanasi, Volume-III ,Edition ,Reprint - 2009 , Madhyama Khanda Mukha roga 61/97,98.Page no.218., Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: laxadi churna , Reference: Astanga Hridaya , Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu ), Additional Information: -
3Intervention ArmProcedure-kavalaH, कवलः (Procedure Reference: Astanga Hriday Uttara tantra 24/33, Procedure details: Yastimadhu ghrita Kavala which was given in both group is reviewed wit its scientific classification ,rasapanchaka,synonyms,phytochemical constituents & antimicrobial activity of individual drugs which are used for preparing i.e.yastimadhu kwatha, yastimadhu kalka.)
(1) Medicine Name: Yastimadhu ghrita , Reference: Astanga Hriday uttara tantra 24/33., Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Aged between 12-40 yrs of either sex.
2.Patients diagnosed as upakusha (Mild to moderate chronic periodontitis) 
 
ExclusionCriteria 
Details  1.Patients having dental caries, sinuses of gums and oral cancers.
2.Patient on blood thinning medications.
3.Pregnant woman
4.Haemorrhagic disorders.
5.Necrotizing periodontitis
6.Patients contraindicated for scaling 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in bad odour from mouth and bleeding gums ,tartar over tooth and scaling over the teeth  7days 
 
Secondary Outcome  
Outcome  TimePoints 
complete abscence of bad odour from mouth and bleeding gums and scaling over the teeth  45days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 4 
Date of First Enrollment (India)   20/12/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Upakusha is one among the dantamoolagata roga, caused by pitta and rakta dushti characterized by paaka, raktasraava, shotha, daaha, manda vedana, poothi mukha. The samanya chikitsa includes Vamana, Virechana, Shirovirechan, Raktamokshana, Pratisarana, Kavala and Raktapitta chikitsa. If left untreated, it may leads to Saushira, Mahasaushira . Upakusha can be correlated with Periodontitis.

Periodontitis is an inflammatory disease of supporting tissues of the tooth, caused by single or multiple microorganisms resulting in progressive destruction of the periodontal ligament and alveolar bone with pocket formation. It is characterized by redness, swollen gums, bleeding gums, burning sensation; foul smell from mouth. The prevalence of chronic periodontitis in the urban population was found to be 42.3% (localized form - 29.3% and generalized form - 13%).

The management includes cleaning the pockets around the tooth, the teeth involved by periodontal disease can be saved if the bone loss has not been too extreme, irritants are removed by scaling and curettage and pocket are eliminated by gingival recession or by surgical removal of gingiva; osseous deformities are eliminated and tooth supporting tissues are recontoured to a normal physiologic architecture; occlusal force are balanced; and systemic factors are corrected. Finally gingivectomy and gingivoplasty, which are quite expensive and cause lot of inconvenience to the patients.

To develop a cost effective and safe Ayurveda treatment protocol for management of Upakusha (periodontitis) this clinical study of lekhana (scaling), dasanasamskara choorna  pratiasarana and yashtimadhu ghrita kavala is being taken up.

Lekhana (scaling), laakshadi choorna  pratiasarana and yashtimadhu ghrita kavala is taken as control.  

Lekhana (scaling) does rakta shodhana by causing raktamokshana. Pratisarana of laakshaadi churna and dashana samskaara churna helps in alleviating the symptoms as their ingredients have shodhana, lekhana and ropana properties.

 
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