| CTRI Number |
CTRI/2024/11/076931 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry
Other (Specify) [Herbal Tooth Paste ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to evaluate the Safety and Benefits of Akayu Dantvam Herbal Toothpaste for Better Oral Health. |
|
Scientific Title of Study
|
An Open-label, Single-Arm, Single-Centre Clinical Study To Evaluate The Safety And Efficacy Of Akayu Dantvam In Improvement Of Oral Hygiene |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2416 Version No. 1.0 Dated 29 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monica Rao |
| Designation |
Dental Surgeon |
| Affiliation |
Tash Dent A Multispeciality Dental Care Clinic |
| Address |
Ground Floor, Slve Inn,
Plot 1839 1st Cross Road, Putlanpalya, 9th Block Jayanagar
Bangalore
KARNATAKA
560069
India |
| Phone |
6364467752 |
| Fax |
|
| Email |
drmonicarao.tashdent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
No.1204, Ashva, 2nd Floor,
26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
No.1204, Ashva, 2nd Floor,
26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Ayubal Wellness Pvt. Ltd.
H1-896, Sitapura Industrial Area, Phase 3rd, Jaipur, Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Ayubal Wellness Pvt Ltd |
| Address |
H1-896, Sitapura Industrial Area,Phase 3rd, Jaipur, Rajasthan 302022 |
| 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 Monica Rao |
Tash Dent Multispeciality Dental Care |
Slve Inn, Plot 1839, 1st Cross Road, Putlanpalya,
9th Block Jayanagar
Bangalore
KARNATAKA |
06364467752
drmonicarao.tashdent@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improvement of oral Hygiene |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yes, Brush teeth twice daily using the herbal tooth paste., Ritucarya: NA, Acara Rasayana:NA, Other:The study aims to evaluate the safety and efficacy of the herbal toothpaste in enhancing the oral hygiene (dental health conditions) in 60 healthy volunteers for one month. Volunteers with one or more of these dental conditions (dentin hypersensitivity, plaque, gingival bleeding, halitosis, gum swelling and inflammation, tooth mobility, dental caries, tooth discoloration, and toothache) will be assessed., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Range: Individuals aged 13 to 70 years.
2.Oral Health Status: Participants with mild to moderate gingivitis, plaque accumulation, or dental sensitivity.
3.Oral Hygiene Practices: Willingness to use Akayu Dantvam as the sole oral care product during the study period.
4.Informed Consent: Ability and willingness to provide written informed consent (for minors, consent must be obtained from a parent or guardian).
5.Compliance: Ability and willingness to comply with all study procedures and visits.
|
|
| ExclusionCriteria |
| Details |
1.Severe Oral Conditions: Presence of severe periodontal disease, severe dental caries, or other significant oral pathologies that may interfere with the study.
2.Recent Dental Procedures: Participants who have undergone major dental procedures (such as extractions, implants, or periodontal surgery) within the last three months.
3.Systemic Conditions: Presence of systemic conditions or diseases that affect oral health (e.g., uncontrolled diabetes, immunocompromised status).
4.Allergies: Known allergy or hypersensitivity to any component of Akayu Dantvam.
5.Concurrent Participation: Participation in another clinical trial within the last 30 days or current participation in another clinical study.
6.Pregnancy or Lactation: Pregnant or lactating women.
7.Non-compliance: Any condition or situation that, in the investigator’s opinion, may interfere with the participant’s ability to comply with the study requirements or pose a risk to their safety. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Sensitivity to Hot and Cold:
Measurement Tool: Visual Analog Scale.
Description: Assessment of changes in dental sensitivity to thermal stimuli (hot and cold) as reported by participants.
2.Reduction in Plaque Accumulation:
Measurement Tool: Plaque Index or Modified Quigley-Hein Plaque Index (MQHPI).
Description: Evaluation of the amount of dental plaque on tooth surfaces before and after using Akayu Dantvam.
3.Decrease in Gingival Bleeding:
Measurement Tool: Gingival Bleeding Index.
Description: Measurement of the extent of gingival bleeding as an indicator of gingival health and inflammation.
4.Elimination of Halitosis:
Measurement Tools: Organoleptic assessment and patient-reported outcomes.
Description: Evaluation of the presence and severity of bad breath before and after using Akayu Dantvam.
|
Day 0, Day 14 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Gum Swelling.
2. Prevention of Tooth Loosening.
3. Incidence of Cavities.
4. Improvement in Toothache Severity.
5. Prevention of Tooth Discoloration.
|
Day 0, Day 14 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background and Introduction
This clinical trial aims to evaluate the safety and efficacy of Akayu Dantvam, an innovative oral care product formulated to enhance oral hygiene. Poor oral hygiene is associated with dental issues such as plaque buildup, gingivitis, periodontitis, dental caries, and halitosis, which can lead to discomfort, pain, and potentially severe systemic health problems. Akayu Dantvam is designed to provide comprehensive dental care by reducing plaque, alleviating gingival inflammation, preventing dental caries, and eliminating bad breath. The study will be conducted as an open-label, single-arm, single-center trial to assess the effectiveness of Akayu Dantvam in improving oral hygiene and overall dental health. |