UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039008 |
|---|---|
| Receipt number | R000044482 |
| Scientific Title | Studies on Pathophysiology and Possible Cause of Hie-Symptom -Findings on Sublingual and Body Surface Temperature, Venous Gas Partial Pressure and the Effects of Oral Administration of PDE-5 Inhibitor Tadarafil- |
| Date of disclosure of the study information | 2019/12/26 |
| Last modified on | 2019/12/26 16:09:27 |
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Basic information
Public title
Studies on Pathophysiology and Possible Cause of Hie-Symptom
-Findings on Sublingual and Body Surface Temperature, Venous Gas Partial
Pressure and the Effects of Oral Administration of PDE-5 Inhibitor Tadarafil-
Acronym
Studies on Pathophysiology and Possible Cause of Hie-Symptom
Scientific Title
Studies on Pathophysiology and Possible Cause of Hie-Symptom
-Findings on Sublingual and Body Surface Temperature, Venous Gas Partial
Pressure and the Effects of Oral Administration of PDE-5 Inhibitor Tadarafil-
Scientific Title:Acronym
Studies on Pathophysiology and Possible Cause of Hie-Symptom
Region
| Japan |
Condition
Condition
Hie-Symptom
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hie-symptom is more common in women, with complains of strong cold sensation of fingers and lower limbs during cold weather. From the cyanotic findings of hands and thighs and dark venous blood , blood stasis due to excessive peripheral vein contraction was suspected. Then we studied the changes of sublingual and body surface temperature, venous gas partial pressure in the warm and cold conditions. To examine the role of thermo-dilating effects of nitric oxide (NO), the effects oral administration PDE 5 inhibitor Tadarafil (TDF) were also studied.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The subjects were BMI,blood pressure, heart rate,sublingual and peripheral body surface temperature (hand and lower limb),venous and arterial blood gas partial pressure, and fingertip arterial oxygen saturation were measured. The measurement was carried out at warm indoors (about 23.) and cold outdoors (about 12.). Then 10 mg TDF tablet was taken and all measurements were repeated again at the same time on the next day.
Key secondary outcomes
The subjects were BMI,blood pressure, heart rate,sublingual and peripheral body surface temperature (hand and lower limb),venous and arterial blood gas partial pressure, and fingertip arterial oxygen saturation were measured. The measurement was carried out at warm indoors (about 23.) and cold outdoors (about 12.). Then 10 mg TDF tablet was taken and all measurements were repeated again at the same time on the next day.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The subjects were 17 women under the age of 50 who had no special history of disease (stroke, myocardial infarction, cancer, diabetes, etc.) or medication and had not reached menopause working as a hospital staff. The interview confirmed the presence and site of cold properties during the day and at night, and were grouped into 10 Hie-symptom women (hereinafter, the coldness group) and 7 women who were not (22 to 33 years old, average 26.4 years old). Measurement items BMI, blood pressure, heart rate, sublingual temperature, body surface temperature, venous blood gas part pressure (pO 2, pCO 2), a fingertip artery blood oxygen saturation. The study was conducted at an outside temperature of 12 degrees Celsius or less from November to early March, and measurements were carried out in the room (about 23 degrees Celsius) and in the cold wind removal room outside the room (about 12 degrees Celsius).
Interventions/Control_2
Then 10 mg TDF tablet was taken and all measurements were repeated again at the same time on the next day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
The subjects are women under the age of 50 who have no special history of disease (stroke, myocardial infarction, cancer, diabetes, etc.) or medication and have not reached menopause. Those who have a coldness and those who are not.
Key exclusion criteria
Postmenopausal Women
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Minagawa |
Organization
Okubo Hospital
Division name
Department of Rehabilitation
Zip code
878-0204
Address
6026-2, Kujumachi Kayagi, Taketa Shi, Oita Ken, 878-0204, Japan
TEL
0974-64-7777
reha@okubo-hp.com
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Minagawa |
Organization
Okubo Hospital
Division name
Department of Rehabilitation
Zip code
878-0204
Address
6026-2, Kujumachi Kayagi, Taketa Shi, Oita Ken, 878-0204, Japan
TEL
0974-64-7777
Homepage URL
reha@okubo-hp.com
Sponsor or person
Institute
Okubo Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japan Health Development Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okubo Hospital
Address
6026-2, Kujumachi Kayagi, Taketa Shi, Oita Ken, 878-0204, Japan
Tel
0974-64-7777
reha@okubo-hp.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大久保病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.32279/jjhr.39.0_62
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.32279/jjhr.39.0_62
Number of participants that the trial has enrolled
17
Results
There was no difference in fingertip arterial blood oxygen saturation in both groups either at indoor or outdoor conditions, and even after taking TDF. In the cold outdoor, the subjects with Hie-symptom, compared to without Hie-symptom, showed significantly lower body surface temperature and venous blood pO2, and increased pCO2. After taking TDF, although sublingual temperature and the decrease in body surface temperature outside the room improved in both groups, the improvement was greater in Hie-symptom.
Results date posted
| 2019 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were 17 women under the age of 50 who had no special history of disease (stroke, myocardial infarction, cancer, diabetes, etc.) or medication and had not reached menopause. The interview confirmed the presence and site of cold properties during the day and at night, and were grouped into 10 Hie-symptom women (hereinafter, the coldness group) and 7 women who were not (22 to 33 years old, average 26.4 years old).
Participant flow
The subjects were 17 women under the age of 50 who had no special history of disease (stroke, myocardial infarction, cancer, diabetes, etc.) or medication and had not reached menopause. The interview confirmed the presence and site of cold properties during the day and at night, and were grouped into 10 Hie-symptom women (hereinafter, the coldness group) and 7 women who were not (22 to 33 years old, average 26.4 years old).
Adverse events
Nothing
Outcome measures
BMI, Blood pressure, heart rate, sublingual temperature, body surface temperature, venous blood gas spectroscopy (pO2, pCO2), fingertip artery blood oxygen saturation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044482
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