| CTRI Number |
CTRI/2015/07/006058 [Registered on: 31/07/2015] Trial Registered Prospectively |
| Last Modified On: |
12/05/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of ‘AHPL/AYTAB/1514’ in bad breath (halitosis) |
|
Scientific Title of Study
|
An open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of ‘AHPL/AYTAB/1514’ in patients suffering from halitosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHPL/AYTAB/1514/2015/CT-1, Version 0 dated 03.04.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yusuf K Chunawala |
| Designation |
Professor, HOD, Department of Pedodontics & Preventive Dentistry |
| Affiliation |
M.A. Rangoonwala College of Dental Sciences & Research Centre |
| Address |
2nd Floor M.A. Rangoonwala College of Dental Sciences & Research Centre 2390-B KB Hidayatullah Road Azam Campus Pune-1
Pune
MAHARASHTRA
411001
India |
| Phone |
9890325152 |
| Fax |
|
| Email |
yusufkc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Head - R & D Centre |
| Affiliation |
Ari Healthcare Pvt. Ltd. |
| Address |
Ari Healthcare Pvt. Ltd R & D Centre Unit No 401 International Biotech Park
BTS 2 Building Chrysalis Enclave 4th floor Plot No 2A MIDC Phase II Hinjewadi Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
8550990792 |
| Fax |
|
| Email |
sanjay.n@arihealthcare.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Nipanikar |
| Designation |
Head - R & D Centre |
| Affiliation |
Ari Healthcare Pvt. Ltd. |
| Address |
Ari Healthcare Pvt. Ltd R & D Centre Unit No 401 International Biotech Park
BTS 2 Building Chrysalis Enclave 4th floor Plot No 2A MIDC Phase II Hinjewadi Pune
MAHARASHTRA
411057
India |
| Phone |
8550990792 |
| Fax |
|
| Email |
sanjay.n@arihealthcare.in |
|
|
Source of Monetary or Material Support
|
| Ari Healthcare Pvt. Ltd., R & D Centre, Unit No.-401, International Biotech Park,
BTS 2 Building, Chrysalis Enclave, 4th floor,
Plot No.-2A, MIDC, Phase-II, Hinjewadi, Pune-411057 |
|
|
Primary Sponsor
|
| Name |
Ari Healthcare Pvt Ltd |
| Address |
R & D Centre, Unit No.-401, International Biotech Park,
BTS 2 Building, Chrysalis Enclave, 4th floor,
Plot No.-2A, MIDC, Phase-II, Hinjewadi, Pune-411057 |
| 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 Yusuf K Chunawala |
M.A. Rangoonwala College of Dental Sciences & Research Centre |
Department of Pedodontics and Preventive Dentistry, Second Floor, 2390-B KB Hidayatullah Road Azam Campus Pune
Pune
MAHARASHTRA |
9890325152
yusufkc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of MCE Society, Azam Campus, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Halitosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
‘AHPL/AYTAB/1514’ Tablet
|
Contains Haridra (Curcuma longa), Pippali (Piper longum) and Putiha (Mentha arvensis)
Dosage and treatment duration: All study subjects will receive 2 tablets of ‘AHPL/AYTAB/1514’ four times a day (i.e. 2 tablets after breakfast, 2 tablets after lunch, 2 tablets after evening tea time/ snacks and 2 tablets after dinner) orally for 60 days.
All study subjects will be advised to keep 2 tablets of ‘AHPL/AYTAB/1514’ beneath the tongue and allow them to dissolve.
From day 60 onwards till day 75, all study subjects will be advised not to use the study drug and come to follow up on day 75 (last study visit) to observe any relapse/recurrence of halitosis. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects of age between 18-54 years
2.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form
3.Subjects suffering from moderate to severe halitosis analyzed on Bad Breath Analyzer
4.Subjects not suffering from severe gingival diseases |
|
| ExclusionCriteria |
| Details |
1.Subjects who had destructive periodontal disease or who had undergone a periodontal surgery in the past three months will be excluded from the study
2.Subjects with Loe and Silness gingival index score 3
3.Subjects with Turesky modification of Quiely Hein index score of more than 4
4.Subject who used antibiotic, antimicrobial, analgesic medications, mouthwash, mouth fresheners or desensitizing toothpaste during the previous 1 month
5.Subject having any history of dentine hypersensitivity treatment
6.Subject having any removable device such as a removable partial denture or orthodontic retainer
7.Subject having presence of any ï¬xed appliance, large or defective restorations, cracked enamel
8.Subjects with any medically compromised conditions contraindicating the oral examination
9.Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders
10.Subjects with significant abnormal laboratory parameters
11.ECG demonstrating any signs of uncontrolled arrhythmia acute ischemia and X ray chest showing any active lesion of tuberculosis
12.Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scale |
Screening visit, Day o, Day 15, Day 30, Day 45, Day 60 and Day 75 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of Gingivitis
2.Assessment of dental plaque
3.Assessment of intensity of Sore throat
4.Assessment of intensity of Cough
5.Assessment of acceptability of trial drug
6.Assessment of incidence and severity of infections
7.Assessment of Quality of Life
8.Assessment of overall treatment satisfaction by patient and physician
9.Assessment of drug compliance
10.Assessment of adverse events
11.Assessment of changes in laboratory parameters |
Screening visit, Day o, Day 15, Day 30, Day 45, Day 60 and Day 75 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/08/2015 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an open label, interventional, single center, prospective clinical study to evaluate efficacy and safety of ‘AHPL/AYTAB/1514’ in patients suffering from halitosis. Patients will be recruited from M.A. Rangoonwala College of Dental Sciences & Research Centre, 2390-B, KB Hidayatullah Road, Azam Campus, Pune-1, India. subjects will be advised to take 2 tablets of ‘AHPL/AYTAB/1514’ four times a day (i.e. 2 tablets after breakfast, 2 tablets after lunch, 2 tablets after evening tea time/ snacks and 2 tablets after dinner) orally for 60 days. All study subjects will be advised to keep 2 tablets of ‘AHPL/AYTAB/1514’ beneath the tongue and allow them to dissolve. From day 60 onwards till day 75, all study subjects will be advised not to use the study drug and come to follow up on day 75 (last study visit) to observe any relapse/recurrence of halitosis. Primary outcome will be to evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scale at screening visit, day o, day 15, day 30, day 45, day 60 and day 75. Secondary outcomes would be assessment of Gingivitis on Loesan and Silness gingival index score, assessment of dental plaque on Turesky modification of Quigley Hein index score, assessment of intensity of Sore throat on a 4 points scale, assessment of intensity of Cough on a 4 points scale, assessment of acceptability of trial drug, assessment of incidence and severity of infections during study period, assessment of Quality of Life, assessment of overall treatment satisfaction by patient and physician on global assessment scale for overall improvement, assessment of drug compliance, assessment of adverse events/adverse drug reactions, assessment of drug tolerability and assessment of changes in laboratory parameters. The time points for secondary outcomes will be screening visit, day o, day 15, day 30, day 45, day 60 and day 75 |