Protocol summary

Summary
Local analgesics for pain control can provide effective local approach. Local agents have similar efficacy without systemic side effects of oral formulations. Plants are rich and intact source of compounds and medical plants have been used without any significant side effects in traditional medicine since ages. In this study Wormwood extract was studied due to its use in traditional medicine as an analgesic in pain management. The present study is a clinical trial and double blind study. Patients with primary ostheoarthritis in at least one knee, will randomly divide into three groups. Group I receive absinthium ointment, Group II absinthium liniment and Group III piroxicam gel.All drugs will use in simillar pakage with different code. At the beginig of the experiment and two weeks after the commencement of treatment and two weeks after the end of the treatment the WOMAC and VAS indexes will examine and the Repeat Measure ANOVA test will compare results.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202123109N3
Registration date: 2012-05-05, 1391/02/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Fatemeh Zeraati
Name of organization / entity
Hamadan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6295
Email address
zeraati@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparisson of absinthium ointment and liniment analgesia with piroxicam gel in patients with knee osteoartheritis
Public title
herbal analgesic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Primary osteoarthritis 2.Existence of pain at least during two week before treatment exclusion criteria: 1.secondary osteoarthritis 2.trauma 3. Endocrine disease(hyperthyroid,hypothyroid ,Diabet) 4.Metabolic disease 5.other arthritis disease 6.corticosteroid usage 7.topical drug usage in simillar site 8.analgesic drug usage from 10 days befor 9.pregnancy
Age
From 30 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan Medical School
City
Hamadan
Postal code
Approval date
2010-07-14, 1389/04/23
Ethics committee reference number
57231/9/35/16/پ

Health conditions studied

1

Description of health condition studied
arthrosis of knee
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis

Primary outcomes

1

Description
pain
Timepoint
At the begining,two week after treatment and two week after stop of treatment
Method of measurement
VAS index

Secondary outcomes

1

Description
action quality
Timepoint
At the begining,two week after treatment and two week after stop of treatment
Method of measurement
WOMAC index

Intervention groups

1

Description
Group I: receive absinthium ointment.2 centimeter Every 8 hour on all of site of knee for 4 week
Category
Treatment - Drugs

2

Description
Group II:recive absinthium liniment 2 ml Every 8 hour on all of site of knee for 4 week
Category
Treatment - Drugs

3

Description
Group III:recive piroxicam gel 2 centimeter Every 8 hour on all of site of knee for 4 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan Medical School
Full name of responsible person
Street address
City
Hmadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Tavilani
Street address
Deputy dean for Research of Hamadan Medical School
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Zeraati fatemeh
Position
Associated professor of pharmacology
Other areas of specialty/work
Street address
Hamadan Medical School
City
Hamadan
Postal code
Phone
+98 81 1822 6011
Fax
Email
zeraati@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
pharmacology Dep.
Full name of responsible person
Zeraati Fatemeh
Position
PhD
Other areas of specialty/work
Street address
Hamadan Medical School
City
Hamadan
Postal code
Phone
+98 11 8822 6011
Fax
Email
zeraati@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pharmacology Dep.
Full name of responsible person
Zeraati fatemeh
Position
PhD
Other areas of specialty/work
Street address
Hamadan Medical School
City
Hamadan
Postal code
Phone
+98 81 1822 6011
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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