| CTRI Number |
CTRI/2020/09/027919 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
09/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Herbal toothpaste and mouthwash in the management of pyorrhoea. |
|
Scientific Title of Study
|
A pharmaceutico-analytical study of trivargtrityadi yoga (TTY) in different formulations in the management of upkusha (Pyorrhoea). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi |
| Designation |
Research Scholar |
| Affiliation |
Dsrrau Jodhpur |
| Address |
Room No 36 Department of Rasashastra and Bhaishajya Kalapana Dr S R Rajasthan Ayurved University Karwar Jodhpur Nagaur Highway Road Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07737890026 |
| Fax |
|
| Email |
ravisharma4194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Sahay Shukla |
| Designation |
Professor and HOD |
| Affiliation |
Dsrrau Jodhpur |
| Address |
Room No 33 Department of Rasashastra and Bhaishajya Kalpana Dr S R Rajasthan Ayurved University Karwar Jodhpur Nagaur Highway Road Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
08769058254 |
| Fax |
|
| Email |
dr.govindshukla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi |
| Designation |
Research Scholar |
| Affiliation |
Dsrrau Jodhpur |
| Address |
Room No 36 Department of Rasashastra and Bhaishajya Kalpana Dr S R Rajasthan Ayurved University Karwar Jodhpur Nagaur Highway Road Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
07737890026 |
| Fax |
|
| Email |
ravisharma4194@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S R Rajsthan Ayurved University Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
University College of Ayurveda DSRRAU Jodhpur |
| Address |
Karwar Jodhpur Nagaur Highway Road Jodhpur |
| Type of Sponsor |
Government 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 Ravi Sharma |
DSRRAU Hospital Jodhpur |
OPD No 10 Swasthya Rakshan Unit University college of Ayurved DSRRAU Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
07737890026
ravisharma4194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Comittee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: A318||Other mycobacterial infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trivargtrityadi Churna with Mouthwash |
Daily Apply 3 gm Churna and 10 ml Mouthwash Twice a Day For One Month |
| Comparator Agent |
Trivargtrityadi Toothpaste with Mouthwash |
Daily Apply 5 gm Toothpaste and 10 ml Mouthwash Twice a Day For One Month |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Bleeding Gums
Gingivitis
Recurrences of Gum Swelling
Toothache
Tooth Decay
Tarter or Plaque
Halitosis |
|
| ExclusionCriteria |
| Details |
Third Degree of Loose Tooth
Leucoplakia
Any Type of Tumor and Carcinoma in Oral Cavity
Cracked Tooth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Sign and Symptoms of Upkusha |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
1 month |
|
|
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)
|
29/09/2020 |
| 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="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Here In this study I have planned to do comparative clinical trial of Trivargtrityadi Churna and Trivargtrityadi Toothpaste in two groups: group A and group B For group A Trivargtrityadi Churna (TT Churna) is indicated to mixed with honey and to rub on the teeth for a maximum time period of one month For group B Trivargtrityadi Toothpaste (TT paste) is gently apply on tooth for a maximum time period of one month Trivargtrityadi Mouthwash is also prepare for the purpose of cleansing of teeth for both groups The assessment will be done on the basis of change in the sign and symptoms of Pyorrhoea Qualitative and Quantitative variables |