Unique ID issued by UMIN | UMIN000023481 |
---|---|
Receipt number | R000026673 |
Scientific Title | The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial |
Date of disclosure of the study information | 2016/08/04 |
Last modified on | 2020/02/14 13:20:13 |
The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial
The effectivity of nifedipine ointment for anal fissures
The effectivity of nifedipine ointment for anal fissures Comfiematory clinical trial
The effectivity of nifedipine ointment for anal fissures
Japan |
anal fissure
Gastrointestinal surgery |
Others
NO
to demonstrate the efficacy and the safety of the nifedipine ointment
Safety,Efficacy
Confirmatory
Others
Not applicable
the rate of improvement of the pain from the anal fissure after the use of the nifedipine ointment
the change of the maximum anal resting pressure and squeezing pressure bfore and after the therapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
No need to know
1
Treatment
Medicine |
The patients put the nifedipine ointment on their anal verges once a day for 3 months.
20 | years-old | <= |
Not applicable |
Male and Female
1.over the age of twenty
2.the patients suffering from the pain or bleeding for the anal fissures
3.the patients suffering from the persisting pain despite of traditional treatments
4.the patients obtained the informed consent
1.the patients who are unable to put the ointment to their anal verges
2.the patients who have the physical stenosis requiring surgical intervention
3.the patients who have the severe cardiovascular, blood, respiratory, neuropsychiatric, autimmune diseases
4.pregnancy or lactating women
5.the patients found inadequate for this study
30
1st name | Yoshiko |
Middle name | |
Last name | Aikawa |
Matsuda hospital
colo-proctology department
4328061
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
053-448-5121
aiko-a@matsuda-hp.or.jp
1st name | Yoshiko |
Middle name | |
Last name | Aikawa |
Matsuda hospital
colo-proctology department
4328061
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
053-448-5121
aiko-a@matsuda-hp.or.jp
Matsuda hospital
Matsuda hospital
Self funding
Matsuda Hospial
753 Irino-cho, Nishi-ku, Hamamatsu city, Shizuoka
0534485121
crc@matsuda-hp.or.jp
NO
松田病院 (静岡県)
2016 | Year | 08 | Month | 04 | Day |
https://doi.org/10.3862/jcoloproctology.72.53
Published
https://doi.org/10.3862/jcoloproctology.72.53
32
Change of face scale (FS)
FS at defecation and resting significantly decreased. (p<0.001)
Effective group and invalidity group
The invalid cases were common in men.
As for the invalid cses, MRP were significantly high level.
2020 | Year | 02 | Month | 14 | Day |
We intended for the 40 patients(20 years or older) with anal fissure which is not improved by conservative treatment.
We applied nifedipine ointment to anal verge with a cotton swb or a finger once a day.
One patient had a headache and it was effective, but canceled use.
We evaluated pain in FS(face scale) before treatment and 2 weeks later, 1,2,3 months later.
We evaluated MRP(maximum resting pressure) before treatment and 1,3 months later.
Completed
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 06 | Month | 21 | Day |
2016 | Year | 07 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2016 | Year | 08 | Month | 04 | Day |
2020 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026673