| CTRI Number |
CTRI/2021/08/035462 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Baccho ke mukhh swasthya ke sandarbh me honey aur Irimeda ka tulnatmak addhyan. |
|
Scientific Title of Study
|
Comparative clinical study for evaluation of role of polyfloral honey and Irimeda( Acacia Farnesiana Wild.) on paediatric oral flora and hygiene.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Pandey |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi government ayurved college Raipur Chhattisgarh. |
| Address |
Department of Kaumarabhritya, Shri narayan prasad awasthi government ayurved college Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492010
India |
| Phone |
8482985047 |
| Fax |
|
| Email |
drshubhammanojpandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant kumar Gupta |
| Designation |
HOD, Department of Kaumarabhritya |
| Affiliation |
Shri Narayan Prasad Awasthi government ayurved college Raipur Chhattisgarh. |
| Address |
Department of Kaumarabhritya, Shri narayan prasad awasthi government ayurved college Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492010
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant kumar Gupta |
| Designation |
HOD, Department of Kaumarabhritya |
| Affiliation |
Shri Narayan Prasad Awasthi government ayurved college Raipur Chhattisgarh. |
| Address |
Department of Kaumarabhritya, Shri narayan prasad awasthi government ayurved college Raipur Chhattisgarh.
Raipur
CHHATTISGARH
492010
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya, Shri narayan prasad awasthi government ayurved college Raipur
Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Pandey |
| Address |
Shri narayan prasad awasthi government ayurved college Raipur Chhattisgarh. |
| 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 Shubham Pandey |
Shri Khudadad Dungaji government ayurved hospital Raipur Chhattisgarh |
OPD no. 7, Department of kaumaranhritya Shri Khudadad Dungaji government ayurved hospital.
Raipur
CHHATTISGARH |
8482985047
drshubhammanojpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee office of The Principal government ayurved college Raipur Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of both sex male and female age 12 to 16 years not having any oral or systemic diseases. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Honey, Reference: API 1 volume 6, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Irimeda( Acacia farnesiana), Reference: Dravyaguna Vijanana vol 2 Dr. J.L.N. Sastry, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: | | 3 | Comparator Arm (Non Ayurveda) | | - | Regular toothpaste | Toothpaste regularly used by subject not containing Irimeda or honey as its constituents. |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of both sex male/female of age group 12 to 16 years.
2. Children not having any oral disease i.e. Dental carries, Tonsillitis,
Pharyngitis.
3. Children with complaint of halitosis, plaque.
4. Children with no h/o antibiotic consumption for last 3 months.
5. Children only with vegetarian diet.
6. Willing and able to participate for the study duration of 15 days.
7. Consent obtained from respective parents/Guardians.
8. Willing to follow the instructions given for the study. |
|
| ExclusionCriteria |
| Details |
1. Children of both sexes Male/Female age below 12years and above 16
years.
2. Children having any oral disease like Tonsillitis, Pharyngitis, Dental
carries.
3. Children with history of antibiotic consumption in last 3 months.
4. Children consuming Non-vegetarian or mix diet.
5. Having any addiction i.e. tobacco chewing, smoking, pan etc |
|
|
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 |
| Comparing the effect of Honey, Honey with Irimeda and Irimeda in maintaining paediatric oral flora and hygiene. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in subjective and objective parameters after treatment. |
At the end of 15 days |
|
|
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/08/2021 |
| 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="2"
Days="0" |
|
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
|
Study is multiple arm participant blind prospective randomized clinical trial for evaluation of role of poly floral honey, Irimeda( Acacia Farnesiana Wild.) on paediatric oral flora and hygiene. Volunteers will be selected from OPD dept. of kaumarabhritya of Shri khudadad dungaji govt. ayurved hospital and schools from Raipur Chhattisgarh. Three groups A, B, C will be taken into clinical trial each containing 20 subjects. where group A will receive Honey group B will receive Honey with Irimeda stem bark churn churna and group C will be given regular toothpaste for brushing for 15 days. Assessment will be done on the basis of subjective and objective parameters before and after intervention. |