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Clinical trials
(5)
Last Verified: June/30/2014
First Submitted: November/18/2008
First Posted: November/19/2008
Last Update Posted: July/7/2014
Sponsors: Marjan Industria e Comercio ltda
Status: Completed
Description
Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation.
Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales.
Side effects will be monitorized throughout the study.
Condition or disease
Condition or disease: Anxiety Disorder
Location
Brazil
Phase
Phase 3
Study design
| Study type: | Interventional |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Last Verified: September/30/2016
First Submitted: February/14/2014
First Posted: February/18/2014
Last Update Posted: October/27/2016
Sponsors: Universidade Federal de Sergipe
Status: Completed
Description
In this research, characterized as a randomized, double-blind, parallel study, 200 healthy volunteered patients aging 18 or older will be distributed into 4 groups (n=50) as follows: Group I - 500mg Erythrina mulungu; Group II - placebo; Group III ; 100 mg Passiflora incarnata; Group IV - 15 mg midazolam. All treatments will be administered p.o. 1 hour randomly prior to the surgical procedures. The level of anxiety will be assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration in three periods: at baseline, right before the surgical procedures and after 7 days. Data will be collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.
Condition or disease
Condition or disease: Dental Anxiety; Impacted Third Molar Tooth
Location
Brazil
Phase
Phase 2/Phase 3
Study design
| Study type: | Interventional |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Last Verified: July/31/2010
First Submitted: August/7/2010
First Posted: August/9/2010
Last Update Posted: August/9/2010
Sponsors: Millet Roux
Status: Unknown status
Description
The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.
The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).
Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?
Condition or disease
Condition or disease: Anxiety Disorders
Location
Brazil
Phase
Phase 3
Study design
| Study type: | Interventional |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Last Verified: June/30/2009
First Submitted: July/21/2009
First Posted: July/22/2009
Last Update Posted: July/23/2009
Sponsors: Ativus Farmaceutica Ltda
Status: Unknown status
Abstract
To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.
Clinical study phase III, multicenter, prospective, open.
Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
Condition or disease
Condition or disease: Anxiety; Efficacy; Tolerability
Location
Brazil
Phase
Phase 3
Study design
| Study type: | Interventional |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy
Last Verified: July/31/2019
First Submitted: September/21/2009
First Posted: September/22/2009
Last Update Posted: August/12/2019
Sponsors: Oregon Health and Science University
Status: Withdrawn
Abstract
The purpose of the Phase II clinical trial will be to see if a botanical extract from the plant Passiflora incarnata can improve seizure control and reduce anxiety in patients diagnosed with partial epilepsy.
The investigators will randomize approximately 25 participants with partial epilepsy for this placebo controlled, double blind, and crossover study. All patients will be scheduled for 10 clinic visits and four telephone visits during the 32-week period of the trial. After enrollment into the study, all participants will begin a 9-week observation phase, which serves as an individual baseline control. After 9 weeks participants will be randomized to receive either study drug or placebo for an 11 week study period. After completion of the 11 week study period, patients will crossover to the other study drug/placebo arm for another 11 weeks. Epilepsy participants will continue taking their anti-epileptic medication as currently prescribed. The investigators will find participants through the OHSU clinics, by notifying local neurologists, anthroposophical and naturopathic practices, and by advertising the study via the local chapter of the American Epilepsy Society.
Routine blood tests, physical examinations and tests to monitor heart, brain and muscle activities will screen for any adverse effects. The primary outcome measure will be seizure frequency through seizure diaries. Attention and performance tests, neurological and quality of life questionnaires will be completed to assess the secondary outcome measures of anxiety, cognitive function and quality of life.
Condition or disease
Condition or disease: Partial Epilepsy
Location
United States
Phase
Phase 2
Study design
| Study type: | Interventional |
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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