| 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
|
|
|
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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: UPAKUSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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: - | | 3 | Intervention Arm | Procedure | - | 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. |