| CTRI Number |
CTRI/2022/07/043641 [Registered on: 01/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess safety and effectiveness of toothpaste in healthy adult subjects |
|
Scientific Title of Study
|
An Open label, Clinical Study to Evaluate the Oral Safety & Efficacy of Himalaya Neem and Pomegranate toothpaste in Healthy Adult Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Ranadheer |
| Designation |
Consultant dentist |
| Affiliation |
Dr Tooth-Cosmetic and Advanced Dental Care |
| Address |
479A 1st Floor 9th Cross 1st Block Jayanagar
Bangalore
Bangalore
KARNATAKA
560011
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
ranadheer.ramachandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi B |
| Designation |
Clinical Team Lead |
| Affiliation |
Himalaya wellness company |
| Address |
Himalaya wellness company 3rd floor R and D
Makali Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
9538969888 |
| Fax |
|
| Email |
dr.swathi.b@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Clinical operations Manager |
| Affiliation |
Himalaya wellness company |
| Address |
Himalaya wellness company 3rd floor R and D
Makali Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya wellness company |
|
|
Primary Sponsor
|
| Name |
Himalaya wellness company |
| Address |
Makali, Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ranadheer |
Dr Tooth Cosmetic and Advanced Dental centre |
479A 1st Floor 9th Cross 1st Block Jayanagar
Bangalore 560011
Bangalore
KARNATAKA |
8867125414
ranadheer.ramachandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: toothpaste, Reference: NA, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with age group 18 years to 60 years in general good health and oral health and are willing to provide consent to the study
2.Subjects with moderate oral hygiene and adhering to basic habits like using standard brush paste
3.No history of any clinically significant medical condition
4.No history of any medical problems requiring hospital care
5.Willing to abide by and comply with the study protocol
6.Available to comply the study procedure for the entire duration of the study.
7.Should not have participated in a similar investigation in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study
|
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of hyper sensitivity to any test product
2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette
3.Pregnant and lactating subjects
4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month
5.Any history of periodontal therapy by surgical interventions
6.Any history of dentine hypersensitivity treatment
7.Any removable appliances such as a removable partial denture or orthodontic retainer
8.Having intrinsic dental stains
9.Having Chronic Generalized Periodontitis
10.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
. To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index
. To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index
. To determine efficacy in Preventing mouth odour, providing of Mouth freshness upto X hours, fresh breath throughout the day, X hours fresh breath, maintain clean and healthy mouth evaluated through subjective self-administered questionnaire.
|
Day 1, day 15 , day30, day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 4. To determine the safety of test product by buccal irritation score and subject reported adverse events. |
Day 1, day 15 , day30, day 45 |
|
|
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)
|
07/07/2022 |
| 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
|
Publication not planned for this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open label,
clinical study to evaluate the oral mucosal safety and efficacy of test product in healthy
adult subjects.
As this is an open-label study, the study
investigator, trial subjects and the study staff will be aware of the
interventions.
Following
provision of informed consent and completion of all screening assessments,
eligible subjects will receive the test product. The
total 40 subjects are expected to complete the study. The subjects will be
evaluated on day 1 (Pre and Post use of test product), day 15, day 30 and day 45
(end of study).
Before
the start of the study all subjects will be given instructions for oral
hygiene, and usage of the products, rinsing time and technique. Subjects will
be instructed to rinse their mouth twice daily, in the morning after brushing
and in the evening before sleeping. All subjects will be asked to avoid eating/drinking food
for 30 minutes before the clinical evaluations.
Along
with the test product, all subjects will receive instructions for usage of the
product and questionnaires. The study duration is of 6 weeks, during which, the
subjects will be instructed to rinse their teeth twice daily with the test
product. The subjects will undergo safety and efficacy assessments at Day 1,
Day 15, Day 30 and Day 45.
All
AEs will be followed until resolution or deemed stable or until the event is
found to be due to another known cause (concurrent condition or medication) and
clinical judgment indicates that further evaluation is not warranted. Should an
Investigator be made aware of any serious AE (SAE) occurring any time after the
active reporting period, the SAE (in case of reasonable causality) will be
reported to Sponsor within 24 hours. |