Clinical trial of â??AHPL/AYTOP/2014Aâ?? Gel in mouth ulcer

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008386
• Date of registration: 21-04-2017
• Prospective Registration: Yes
• Primary sponsor: Ari Healthcare Pvt Ltd
• Public title: Clinical trial of â??AHPL/AYTOP/2014Aâ?? Gel in mouth ulcer
• Scientific title: Evaluation of efficacy and safety of â??AHPL/AYTOP/2014Aâ?? in patients suffering from aphthous ulcers - an open label, randomized, multi-center, prospective, active controlled, parallel group, clinical study. - NIL
• Date of first enrolment: 24-04-2017
• Target sample size: 250
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18623
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Open Label
• Phase: Phase 3/ Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Sanjay Nipanikar
• Affiliation: Ari Healthcare Pvt. Ltd.

• Name: Dr Sanjay Nipanikar
• Affiliation: Ari Healthcare Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1.Patients clinically diagnosed as aphthous ulcers

2.Minor Mouth ulcers that have appeared less than a week prior to the enrollment

3.Ulcers at accessible locations (labial, buccal mucosa, tongue preferably)

4.Who can make all necessary visits and comply with the study procedures

5.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form


Exclusion criteria: 1.Subjects Suffering from any other oral or dental disease or active skin disease.

2.Patient under treatment of ulcers with systemic steroids, vitamins, antibiotics, antihistamines, oral Retinoids or immunomodulatory agents within three months before study entry.

3.Patients having any major systemic diseases including genetic, endocrinal diseases, cancer, HIV, AIDS

4.Known cases of hematological disorders, ulcerative colitis or Crohns disease.

5.Patient who had a history of probable sensitivity to any mouthwash or toothpaste

6.Patients having Anemia or known iron, folic acid, Vit. B12 deficiency

7.Patient having addiction of alcohol or smoking or tobacco chewing

8.Pregnant or lactating women

9.Patients having known hypersensitivity to ingredients used in the study drugs



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Aphthous Ulcer

Intervention(s)

Intervention1: AHPL/AYTOP/2014A Gel: It contains Piper betel extract, Terminalia chebula extract, Glycyrrhiza glabra extract, Curcuma longa extract and oil of Syzygium aromaticum

Dosage and Treatment Duration:

Local application 4 times a day for 14 days or till complete healing of ulcers whichever is earlier

Control Intervention1: AHPL/AYTOP/2014B Gel: It contains Curcuma longa extract

Dosage and Treatment Duration:

Local application 4 times a day for 14 days or till complete healing of ulcers whichever is earlier

Control Intervention2: AHPL/AYTOP/2014C Gel: It contains Curcuma longa extract and Glycyrrhiza glabra extract

Dosage and Treatment Duration:

Local application 4 times a day for 14 days or till complete healing of ulcers whichever is earlier

Control Intervention3: Market Preparation 1: It contains Acacia araebica extract, Acacia farnesiana extract, Valeriana wallichili extract, Pluchea lanceolota extract, Sassuria lappa extract, Symplocos racemosa extract, Glycyrrhiza glabara extract, Cinnamomum camphora extract and Saccharum officinarum
Dosage and Treatment Duration:

Local application 4 times a day for 14 days or till complete healing of ulcers whichever is earlier

Control Intervention4: Market Preparation 2: It contains Triamcinolone acetonide
Dosage and Treatment Duration:

Local application 4 times a day for 14 days or till complete healing of ulcers whichever is earlier

Primary Outcome(s)

Changes in pain as perceived by patient using VASTimepoint: Day 0, Day 3, Day 7, Day 10, Day 14

Secondary Outcome(s)

1.Changes in burning sensation

2.Number of completely healed ulcers.

3.Number of days required to heal the ulcers

4.Percentage of healing of Index ulcer

5.Changes in ease of consumption of solid and liquid food.

6.Onset of action and duration of action

7.Overall improvement of treatment by patient and physician.

8.Consistency, Taste, Local tolerability, Ease of application of test drugs

9.Adverse events and Tolerability of trial drugsTimepoint: Day 0, Day 3, Day 7, Day 10, Day 14

Secondary ID(s)

AHPL/AYTOP/2014A/2017/CT-1 Version No: V3 (22/02/2017)

Source(s) of Monetary 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.

Ethics review

Status: Approved
Approval date: 26/02/2017
Contact:

Independent Ethics Committee, Dhanashree Hospital, Navi Sangvi, Pune

Status: Approved
Approval date: 28/02/2017
Contact:

KVTR Ayurvedic College, Boradi, Institutional Ethics Committee

Status: Approved
Approval date: 24/04/2017
Contact:

MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Saneguruji Aarogya Kendra, Institutional Ethics Committee