Comparing effect of hydroalcholic extract of combined plants of Cinnamon black pepper and Valerian with diclofenac Na in treatment of urinary tract pain
Design
In this non blinded randomized parallel clinical trial, 80 Patients are allocated randomly with simple sequential allocation in one of the two groups (herbal extract or diclofenac) and receive the intervention of that group.
Settings and conduct
Adult patients older than 18 years old with moderate to severe urinary tract pain referring to Shahid Mofateh clinic of Yasuj suffering from moderate to severe urinary tract pain allocated in one of two groups. The first group will received combined extract of 3 herbs provided in form of capsule prescribed from start of pain for 10 days after meal.In second group tab diclofenac sodium 50 mg is prescribed every 8 hour same as first group. Pain severity of patients(by Visual analogue scale (VAS) and patient records will be checked and recorded by questionnaire during treatment and two weeks after that .Also at beginning and two weeks later urine analysis and renal function tests checked in all patients and will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients older than 18 years old with moderate to severe urinary tract pain, having informed consent form
Noncompliance criteria: Developing any side effects during study, pregnant women ،renal failure, dyspnea, ulcer and inflammation of urinary tract, active infection and those with a history of herbal or medicinal allergy
Intervention groups
In intervention group combined extract of 3 herbs provided in form of capsule prescribed from start of pain for 10 days with after meal.In second group tab diclofenac sodium 50 mg is prescribed every 8 hour same as first group
Main outcome variables
Severity of pain according to Visual analogue scales (VAS) and patient records by questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N26
Registration date:2020-12-04, 1399/09/14
Registration timing:prospective
Last update:2020-12-04, 1399/09/14
Update count:0
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of combined extracts of cinnamon , black pepper and Valerian with oral diclofenac on improvement of urinary tract pain in adults
Public title
Effect of combined extracts of cinnamon , black pepper and Valerian on improvement of urinary tract pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 year old
complain from flank pain or urinary tract pain
Having informed consent to enter study
Exclusion criteria:
Uncontrolled coagulopathy
Azotemia
Pregnancy
Presence of active urinary tract infection
Allergy to medical or herbal drugs
Suffering from cardiovascular or pulmonary disease
Suffering from hepatic disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
patients are allocated randomly with simple sequential allocation in one of the two study groups (combined extract of three herbs or diclofenac) by help of sealed envelope and receive the intervention of the same group. The unit of randomization will be the referred patient. In every envelope, one of two codes (A=combined extract) or (B=diclofenac) will be taken. The sealed envelopes will be placed at the disposal of the expert. With the referral of each patient one of the envelopes will be randomly selected by the patients and will be introduced as a study group. The stratification approach is not used. Concealment will not take place in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741414
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.YUMS.REC.1399.161
Health conditions studied
1
Description of health condition studied
Urinary tract pain
ICD-10 code
R39
ICD-10 code description
Other and unspecified symptoms and signs involving the genitourinary system
Primary outcomes
1
Description
The severity of pain in urinary tract
Timepoint
During the study , two weeks and one month after starting treatment
Method of measurement
With Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Developing drug allergy and hypersensitivity
Timepoint
During and at the end of study
Method of measurement
Patients records and exam
2
Description
Developing renal complications
Timepoint
During and at the end of study
Method of measurement
Check of urine and renal function tests
Intervention groups
1
Description
Intervention group: The combination of cinnamon extract, black pepper and Valerian in equal proportions and in the form of capsules (Armaghan Salamat Zagros Yasuj Company) is prepared and prescribed at a dose of 500 mg every 8 hours after a meal with a glass of water for 10 days.
Category
Treatment - Drugs
2
Description
Control group: Tab diclofenac Na 50 mg every 8 hour is prescribed with a glass of water for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic of Yasuj
Full name of responsible person
Sadrolleh Mehrabi
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 4721
Email
sadrollahm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Mousavizadeh
Street address
Deputy of research, Yasuj University of Medical Sciences,, Motahari St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6074
Email
health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Chairman of Urology Department, Yasuj University of Medical Sciences