Evaluation the effect of topical use of chamomile oil on appeasing of patients with interstitial cystitis: A triple randomized placebo-controlled trial
The aim of this study was to evaluate the local effect of chamomile oil on the severity of symptoms in patients with interstitial cystitis.
Design
Randomised controlled clinical trial and triple blind, parallel study
Settings and conduct
This study is conducted at Kamkar Hospital in Qom and is blinded by placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients elder than 18 years old and history of more than nine months of bladder inflammation .Patients with concomitant symptoms of genital pain, frequent urination and bladder burning. Exclusion criteria: Suffering from intestinal diseases such as Crohn's disease, colitis, peptic ulcer, irritable bowel syndrome (IBS) History of myocardial infarction; coronary bypass surgery during last 6 month
Pregnant women or women who want to have a pregnancy
Intervention groups
patient with Interstitial cystitis symptoms which is divided into two groups of chamomile oil and placebo oil.placebo oil similar to the drug.
Main outcome variables
Interstitial cystitis symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170112031893N2
Registration date:2018-11-13, 1397/08/22
Registration timing:prospective
Last update:2018-11-13, 1397/08/22
Update count:0
Registration date
2018-11-13, 1397/08/22
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of topical use of chamomile oil on appeasing of patients with interstitial cystitis: A triple randomized placebo-controlled trial
Public title
Evaluation the effect of topical use of chamomile oil on appeasing of patients with interstitial cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients elder than 18 years old and history of more than nine months of bladder inflammation
Patients with concomitant symptoms of genital pain, frequent urination and bladder burning
Exclusion criteria:
Suffering from intestinal diseases such as Crohn's disease, colitis, peptic ulcer, irritable bowel syndrome (IBS)
Pregnant women or women who want to have a pregnancy
History of myocardial infarction; coronary bypass surgery during last 6 month
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by Throwing coin and dice
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment.The placebo is a yellow-colored oil that is similar in color to chamomile oil.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Qom University of Medical Sciences
Street address
Plaque 83, 4th Alley, 1/1 Lane, Safashar Street
City
Qom
Province
Ghoum
Postal code
87366-37169
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.MUQ.REC.1397.088
Health conditions studied
1
Description of health condition studied
Interstitial cystitis
ICD-10 code
N30.1
ICD-10 code description
Interstitial cystitis (chronic)
Primary outcomes
1
Description
Symptom of Interstitial Cystitis
Timepoint
Prior to study, second week, fourth week , eighth week and at the end of study
Method of measurement
O leary index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group used chamomile oil amount 5 cc for 2 months, every day in the bladder area
Category
Treatment - Drugs
2
Description
Control group: The group used placebo oil amount 5 cc for 2 months, every day in the bladder area