| CTRI Number |
CTRI/2018/12/016658 [Registered on: 13/12/2018] Trial Registered Prospectively |
| Last Modified On: |
12/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effects of trip hala decoction and honey gargle and only trip hala decoction gargle on oral health. |
|
Scientific Title of Study
|
A comparative study of the efficacy of gandusha by triphala kwath with and without madhu(honey) as a dinacharya upakram in mukhaswasthya(oral health). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpesh Devendra Wani |
| Designation |
PG Scholar |
| Affiliation |
PDEA’S College of Ayurved and Research Centre, Akurdi, Pune 44 |
| Address |
Swasthvrutta Department,
2nd year MD.
Pune
MAHARASHTRA
411044
India |
| Phone |
9960136359 |
| Fax |
02027659578 |
| Email |
ayushkamiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
HOD |
| Affiliation |
PDEA’S College of Ayurved and Research Centre, Akurdi, Pune 44 |
| Address |
Swasthvritta Department,
2nd year MD.
Pune
MAHARASHTRA
411044
India |
| Phone |
9960136359 |
| Fax |
02027659578 |
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Devendra Wani |
| Designation |
PG Scholar |
| Affiliation |
PDEA’S College of Ayurved and Research Centre, Akurdi, Pune 44 |
| Address |
Swasthvrutta Department,
2nd year MD.
Pune
MAHARASHTRA
411044
India |
| Phone |
9960136359 |
| Fax |
02027659578 |
| Email |
ayushkamiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Sector No. 25, Akurdi, Pradhikaran, Pune-44 |
|
|
Primary Sponsor
|
| Name |
Dr Kalpesh Devendra Wani |
| Address |
Swasthvrutta Department, PDEA’S College of Ayurved and Research Centre, Akurdi, Pune 44 |
| Type of Sponsor |
Other [PG Student] |
|
|
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 Kalpesh Devendra Wani |
PDEA’s Ayurved Rugnalaya and Sterling Multispecialty Hospital |
Swathyarakshan OPD, Room No. 23
Pune
MAHARASHTRA |
9960136359
02027659578
ayushkamiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of PDEAs college of Ayurved and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Triphala kwath
and madhu |
Triphala kwath- 150ml
and madhu-10ml
OD for 1 month |
| Comparator Agent |
Triphala kwath |
Triphala kwath- 150ml
OD for 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Volunteers with pH of the saliva <7
2. Volunteers willing to do gandusha upakram
3. Volunteers of the age group 18 to 50 irrespective of sex, religion, occupation, Socio-economic status.
4. Volunteers who agreed to refrain from oral hygiene procedures for 12 hours will be included in the study.
5. Volunteers ready to give written informed |
|
| ExclusionCriteria |
| Details |
1. Volunteers with pH of the saliva >7
2. Volunteers don’t willing to do gandusha upakram
3. Patients on antibiotic or antimicrobial treatments
4. Patients with chronic oral diseases like oral cancer etc.
5. Pregnant Women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mukhaswastyakar effects of Gandusha |
Time-Points: 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mukhaswastyakar effects of Gandusha |
Time-Points: 15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/12/2018 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication has been done till now. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, single blind, single centre trial comparing the efficacy
of gandusha by triphala kwath with and without Madhu (honey) daily for 30 days
in 80 healthy volunteers that will be conducted in a single centre in India. |