| CTRI Number |
CTRI/2025/09/094584 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Kanadi Churna Pratisarana and Madhu mishrit Panchvalkal Kwath gandush in Dantveshta (Pyorrhoea alveolaris) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Kanadi Churna Pratisarana and Madhu mishrit Panchvalkal Kwath gandush in Dantveshta (Pyorrhoea alveolaris) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishu Kumari |
| Designation |
PGScholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Dental OPD , OPD3 , department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan phase 1, roorkee Road, haridwar, Uttarakhand, India 2409405
Hardwar UTTARANCHAL 249405 India |
| Phone |
9639047868 |
| Fax |
|
| Email |
ishu.1997.kumari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Jyoti Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 3 , department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan phase 1, roorkee Road,
Hardwar UTTARANCHAL 249405 India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Jyoti Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 3 , department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan phase 1, roorkee Road,
UTTARANCHAL 249405 India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, haridwar , Uttarakhand, India 249405 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishu Kumari |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Department Of Shalakya Tantra OPD 3,Department Of Dental patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,phase 1, Roorkee road, Haridwar,Uttaranchal Hardwar UTTARANCHAL |
9639047868
ishu.1997.kumari@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: DANTAVESHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: Yogaratnakar, Procedure details: Using index finger, gentle application & rubbing of Kanadi churna on gum area for 10 minutes twice a day.) (1) Medicine Name: Kanadi churna, Reference: Yogaratnakar, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Yogaratnakar, Procedure details: Holding 50ml of Madhu Mishrit Panchvalkal Kwath in oral cavity without gargling until patient develops watery discharge from nose & eyes. ) (1) Medicine Name: Madhu Mishrit Panchvalkal Kwath, Reference: Yogaratnakar, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 15 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanadi Churna, Reference: Yogaratnakar, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Madhu Mishrit Panchvalkal Kwath, Reference: Yogaratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients presenting with classical features of Dantveshta such as bleeding gums, mobile tooth, pus discharge from gums.
2. Age group between 20-60yrs.
|
|
| ExclusionCriteria |
| Details |
1. patient below 20yrs of age and above 60yrs
2. pregnant or lactating females.
3. patients with some mental disability.
4. Other types of Dantmulgat rogas.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters will be assessed-
1. Raktasrava(blood gums)
2.Chaladanta(Tooth mobility)
|
0,2 weeks,4 weeks,6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Durgandhya(offensive odous or halitosis)
2. Puyasrava(Pus discharge) |
0,2 weeks,4 weeks,6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="8" 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
|
In this trial we are selecting the patients of Dantveshta in which we will do the intervention in two groups- 30 patients in each group. In one group, we will intervene with ayurvedic therapeutic procedure of Pratisarana with kanadi churna , whereas in other group we will intervene with another ayurvedic therapeutic procedure of gandush with Madhu mishrit panchvalakal kwath. Assessment will be done on the basis of subjective parameters and scoring will be done before and after the treatment. |