Trial Outcomes & Findings for Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus (NCT NCT02329600)
NCT ID: NCT02329600
Last Updated: 2016-11-15
Results Overview
pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
one month after treatment
Results posted on
2016-11-15
Participant Flow
Participant milestones
| Measure |
Control Subjects
10 systemically healthy control subjects taking no medication.
|
OLP and Corticosteroid
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
OLP and Corticosteroid and Green Tea
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
Baseline characteristics by cohort
| Measure |
Control Subjects
n=10 Participants
10 systemically healthy control subjects taking no medication.
|
OLP and Corticosteroid
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
OLP and Corticosteroid and Green Tea
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
38 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
40 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one month after treatmentpain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
Outcome measures
| Measure |
Control Subjects
n=10 Participants
10 systemically healthy control subjects taking no medication.
|
OLP and Corticosteroid
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
OLP and Corticosteroid and Green Tea
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
|---|---|---|---|
|
Pain
|
0 units on a scale
Standard Deviation 0
|
4 units on a scale
Standard Deviation 2.4
|
4.4 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: one month after treatmenttotal oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment
Outcome measures
| Measure |
Control Subjects
n=10 Participants
10 systemically healthy control subjects taking no medication.
|
OLP and Corticosteroid
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
OLP and Corticosteroid and Green Tea
n=15 Participants
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
|
|---|---|---|---|
|
Salivary Total Oxidative Capacity
|
6.37 umol/L
Standard Deviation 4.06
|
58.41 umol/L
Standard Deviation 16.3
|
23.27 umol/L
Standard Deviation 12.95
|
Adverse Events
Control Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OLP and Corticosteroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OLP and Corticosteroid and Green Tea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Noha Ayman Ghallab
Faculty of Oral and Dental Medicine Cairo University
Phone: +201005263365
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place