Intervention : Topical Melatonin(3%) at dosage of 15 mg once daily

Oral Leukoplakia

Topical melatonin at 3% concentration with dosage of 15 mg once daily will be applied on the lesion for 6 weeks followed by a follow up of 3 months

topical melatonin

Topical application of placebo once daily for 6 weeks with a follow up for 3 months

PLACEBO

Post graduate institute of dental sciences

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia: A Randomized Placebo Controlled Study

measurement of the lesion and scored according to RECIST criteria

Grading of dysplasia according to Speight classification (2007).

Percentage of a total number of Ki-67 positive cells to a total number of cells will be primarily deducted.

Postgraduate Institute of Dental Sciences Rohtak

30 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaires during office visits with the gynecologist. In addition, 2 short questionnaires will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3.

30 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaires during office visits with the gynecologist. In addition, 2 short questionnaires will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3.

Sexual Pain Disorders

Postmenopausal Symptoms

Vulvovaginal Atrophy

Female Sexual Dysfunction

Dyspareunia

Vulvodynia

Vestibulodynia

Arousal Disorders, Sexual

Genito-Pelvic Pain/Penetration Disorder

Female Sexual Arousal Disorder

Participant must be a postmenopausal female who has not menstruated for at least one year either because of surgical removal of ovaries and uterus or because of natural menopause. Women taking estrogens, DHEA, can continue to use them during the clinical trial. Women not taking estrogens or are on aromatase inhibitors can enter the trial.

Topical sinecatechins ointment will be applied daily.

Sinecatechins Topical

Placebo

Lila Nachtigall, M.D.

Miriam Greene, M.D.

Elizabeth Eden, M.D.

Cynthia Krause, M.D.

Janis Enzenbacher, M.D.

Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment

10% Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy

Subjects will be asked to rate their pain 0=no pain, 1-3= mild pain, 4-6 =moderate pain; 7-9= significant pain and 10= severe pain

19 questions (6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain). 2 questions for Desire score range 1-5, The sum is multiplied by 0.6 with subscale score range 1.2 to 6.0; 4 questions for Arousal with score range 0-5. The sum is multiplied by 0.3 with a subscale score range 0-6; 4 questions for Lubrication with score range from 0-5. The sum is multiplied by 0.3 with a subscale score range 0-6; 3 questions in the Orgasm with score range from 0-5. The sum is multiplied by 0.4 with a subscale score range from 0-6 ; 4 questions in Satisfaction, 2 questions with a score range 0-5 and 2 questions with a score range 1-5. The sum is multiplied by 0.4 with a subscale score range 0-6; 3 questions in the Pain with score range 0-5. The sum is multiplied by 0.4 with a subscale score 0-6. The Total score 1.2-36.0 equals sum of subscale scores. Lower values are a worse outcome. A Total score of < or= to 26.55 equals Female Sexual Dysfunction.

There are 13 questions to evaluate the level of sexual distress being. For each question the scale range is from 0 - 4. The total score is the derived from the sum of the individual scores from each of the 19 questions. A score of 11 or higher indicates sexual distress.

There are Yes or No questions to evaluate characteristics of symptoms subject is experiencing. The scale range for each question is 0-1. No is scored as 0 and Yes is scored as 1. Higher scores indicate that the subject is experiencing more vulvovaginal symptoms

Questionnaire to determine, level of sexual desire, distress about level of sexual desire, whether a subject engaged in sexual activity, frequency of sexual activity, satisfaction with sexual activity, and whether a subject had an orgasm during sexual activity during the past week. Question 1 has a scale range from 0-3. For question 1 a higher value indicates more sexual desire. Question 2 has a scale range from 0-4. For question 2 a higher value indicates more distress over level of sexual desire. Question 3 has scale range of 0-1 and is a yes or no question about masturbation; Question 4 asks the number of times that the subject had sex during the past week and has a minimum score of 0 and no maximum score. Questions 5 and 6 are Yes or No questions with a 0-1 scale range. Question 5 asks about was sex satisfying. Question 6 asks about whether the subject has an orgasm. The scores to the questions are not combined but reported individually.

A vaginal speculum exam will be performed by the gynecologist to evaluate with a pH paper the vaginal pH

A vaginal speculum exam will be performed by the gynecologist and a gentle swabbing of the lateral vaginal wall will be performed to assess the degree of vaginal atrophy in the postmenopausal subject

Lila Nachtigall, M.D., Professor of Gynecology

GTO Pharmaceutical, LLC

Randomized, Double Blinded, Placebo Controlled

95% Pure ECGC capsules 200mg three times a day with food for 6 months

Multiple Sclerosis

95% Pure ECGC capsules 200mg

Placebo Comparator:

LSU Health Sciences Center

Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

The rate of change will be calculated using all the time points available (baseline,3 and 6 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %cerebrospinal fluid (CSF) and % lesion volume as covariates. All the voxels available for each subject where estimates have a standard deviation(SD) <30 will be used. A spatial anisotropic exponential covariance structure will be used.

Difference between the two groups in brain atrophy as measured by SIENA

Jesus Lovera MD

Assistant Professor

Louisiana State University Health Sciences Center in New Orleans

National Multiple Sclerosis Society

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

Dr. Johannes Levin

Sponsor delegated person

German Center for Neurodegenerative Diseases (DZNE)

Deutsche Parkinson Vereinigung

German Foundation for Neurology

ParkinsonFonds Deutschland gGmbH

Osteoarthritis

AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg).

AquaCal

AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract.

AquaPT

Cork University Hospital

A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects

Randomised, Placebo Controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects

Plasma cytokine concentrations (including TNFα, IL-β, NFκB, COX2 & IL-6)

Western Ontario and McMaster Universities Arthritis Index

Haemaglobin, white cell count, platelet count, haematocrit, differential white count

camellia chrysantha/atrophy

Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia

Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment

Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects

Effects of Antioxidants on Human Macular Pigments

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