Clinical TrialID 490

Cayenne Pepper Cataplasm - Safety Study

NCT03440125

Low Back Pain

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Record Fields

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Clinical Trial Id
490
Evidence Id
490
Core Evidence Id
490
Source Clinical Trial Id
472
Herb2 Clinical Trial Id
HBCT000472
Nct Id
NCT03440125
Title
Cayenne Pepper Cataplasm - Safety Study
Status
Completed
Phase
Phase 1|Phase 2
Study Result
No
Study Condition
Low Back Pain
Study Type
Interventional
Study Design
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Cayenne Pepper topical|DEVICE: Electrical stimulation|PROCEDURE: Massage
Intervention Allocation
Non_Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
30
Outcome Measure
Change in concentration of circulating biomarkers of inflammation, neudroendocrine stress and blood vessel activation, The blood analysis will include standard analysis of hemogram, C-reactive proteins, creatine-kinase, sedimentation, albumin and cortisol. Enzyme-linked immunosorbent assay (ELISA) will include Tumor necrosis factor-Alpha, Interleukin-6, Leukotriene B4 and P-Selectine. Additionally, microRNA analysis will be performed (gene numbers: 1, 21, 23, 25, 103, 126, 133, 146, 155, 199a, 199b, 191, 206, 451., Before the application, 45 minutes after 10th application and 48 hours after 10th application|Change in systolic and diastolic blood pressure, Systolic and diastolic blood pressure \[mmHg\], measured at both sides of the body with blood pressure gauge, Before the application, 45 minutes after 10th application and 48 hours after 10th application|Heart rate, Heart rate (bpm), measured with heart rate monitor belt., Before the application, 45 minutes after 10th application and 48 hours after 10th application
Sponsor Collaborator
University of Primorska|S2P, Science to Practice, Ltd.|Comenius University|Wilhelminenspital Vienna|Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Funded By
OTHER
Location
Facultiy of Physical Education and Sports, Comenius University of Bratislava, Bratislava, 81806, Slovakia|Faculty of Health Sciences, Izola, 6310, Slovenia
Other Id
UP-MunariStudy
Start Date
2016-03-15
Primary Completion Date
2016-11-15
Completion Date
2016-12-15
First Posted
2018-02-20
Results First Posted
Last Update Posted
2018-02-20
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03440125
Title Cn
Title En
Cayenne Pepper Cataplasm - Safety Study
Bilingual Status
semi_complete