| CTRI Number |
CTRI/2024/10/074967 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study effect of Vyoshatrivargadi Yoga from Sushrutasamhita in toothpaste form on Oral Hygiene in adults |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial of Sushrutokta Vyoshatrivargadi Yoga in toothpaste form on Oral hygiene in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Bhagwatrao Jadhav |
| Designation |
Ph D Scholar |
| Affiliation |
Goverment Ayurved College, Nanded |
| Address |
Department of Swasthavritta Second floor Government Ayurved
College Vazirabad, Nanded 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
|
| Fax |
|
| Email |
avi.ayurved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshwant Patil |
| Designation |
Professor and HOD |
| Affiliation |
Goverment Ayurved College, Nanded |
| Address |
Department of Swasthavritta Second floor Government Ayurved
College Vazirabad, Nanded 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422171172 |
| Fax |
|
| Email |
dr.yeshraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Bhagwatrao Jadhav |
| Designation |
Ph D Scholar |
| Affiliation |
Goverment Ayurved College, Nanded |
| Address |
Department of Swasthavritta Second floor Government Ayurved
College Vazirabad, Nanded 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
8975346864 |
| Fax |
|
| Email |
avi.ayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Government Ayurved College, Vazirabad, Nanded, Maharashtra - 431601 INDIA |
|
|
Primary Sponsor
|
| Name |
Avinash Bhagwatrao Jadhav |
| Address |
Department of Swasthavritta and Yoga, Dhanwantari Ayurved Medical College, Udgir, Dist. Latur 413517 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Avinash Bhagwatrao Jadhav |
Government Ayurved College Nanded |
Department of Swasthavritta and Yoga, Government Ayurved College, Vazirabad, Nanded
Nanded
MAHARASHTRA |
8975346864
avi.ayurved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Govt Ayurved College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Participants |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Dantadhavana with Vyoshatrivargadi Yoga in toothpaste form twice a day pea size amount for 60 days, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | White toothpaste | Dantadhavana with White toothpaste twice a day pea size amount for 60 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy participants, who are willing to comply with twice tooth brushing guideline, who are not using or have used herbal toothpaste or mouthwash during past 3 months |
|
| ExclusionCriteria |
| Details |
Who are on antibiotic therapy anytime during past 3 months, Who are undergoing orthodontic therapy and having complex prosthesis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OHI-S Index |
0 day
30 day
60 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary Streptococcus mutans level |
0 day
60 day |
| Salivary Lactobacillus acidophilus level |
0 day
60 day |
| Salivary pH |
0 day
60 day |
| Ayurvedic Subjective Parameters |
0 day
30 day
60 day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
NIL |