| CTRI Number |
CTRI/2023/11/060351 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
Yes |
| 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 and compare effect of Ayurvedic kawal dharan and Chlorhexidine mouthwash in healthy people. |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to evaluate the efficacy of Ashwattha (Ficus religiosa Linn.) and Jambu (Syzygium cumini (Linn.)skeels.) kawal dharan and Chlorhexidine Mouthwash in healthy individuals. |
| 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 Prajakta Arun Patel |
| Designation |
Ph.D. Scholar, Dravyaguna Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna Department
Tilak Ayurveda Mahavidyalaya
583-2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9730045059 |
| Fax |
|
| Email |
praj8285@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asmita Jadhav |
| Designation |
Assistant Professor, Dravyaguna department |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna Department
Tilak Ayurveda Mahavidyalaya
583-2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Jadhav |
| Designation |
Assistant Professor, Dravyaguna department |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna Department
Tilak Ayurveda Mahavidyalaya
583-2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurveda Mahavidyalaya
583-2, Rasta Peth, Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya
583-2 Rasta Peth , Pune 411011 |
| 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 Prajakta Patel |
Seth Tarachand Hospital, Rasta Peth, Pune |
Dravyaguna Department, Tilak Ayurveda Mahavidyalaya
583-2, Rasta Peth, Pune
Pune
MAHARASHTRA |
9730045059
praj8285@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee T.A.M.V. Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
improving oral health |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH | (Procedure Reference: Ashtang Hruday, Uttarsthan, Adhyay 21, Verse no. 20-64, Procedure details: 1) Continue daily normal oral hygiene habit of brushing in morning.
1) Use just after regular tooth brushing .
2) 10 ml kwath ----- 3 swishes (each for 30 seconds with 30 seconds gap in between)
3) Don’t eat or drink anything or rinse mouth for 30 minutes minimum after use of kawal
)
(1) Medicine Name: Ashwattha And Jambu Leaves Kawal , Reference: Vanoushadhi Chandrodaya, Nighantu Adarsh, Ethnomedinal survey, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine Mouthwash | 1) Continue daily normal oral hygiene habit of brushing in morning. 1) Use just after regular tooth brushing . 2) 10 ml mouthwash 1 swish (for 30 seconds) 3) Don’t eat or drink anything or rinse mouth for 30 minutes minimum after use of mouthwash. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals. (Vitals in normal range and systemic exam within normal limits.) |
|
| ExclusionCriteria |
| Details |
Known case of any Major systemic diseases and individuals Under any dental treatment or procedure recently (6 months) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in Winkel Tongue Coating Index |
Baseline, Day 7 & Day 15. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in Winkel Tongue Coating Index |
15 days |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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="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
|
It is a randomized, single blind, parallel group, active controlled trial. It will assess the efficacy of Ayurvedic kawal dharan. Also the effect of kawal dharan will be compared with standard drug, chlrohexidine mouthwash. Trial will be conducted on healthy individuals to assess the effects of two drugs in improving overall oral and dental health. The duration of trial will be 15 days. Primary endpoint will be improvement in symptoms like sense of cleanliness, sense of freshness, pain, halitosis etc.Secondary end point will be improvement in Winkel Tongue Coating Index. Medicine Acceptability Questionnaire will compare the overall acceptability of both formulations. |