(1) Purposes: The purpose of this study is to evaluate the effectiveness of a homeopathic remedy (Rhus-tox or poison ivy) in the treatment and prevention of Delayed Onset Muscle Sourness (DOMS) after an exhaustive workout. (2) Design: The population of volunteers is selected among students of Islamic Azad University, Jahrom branch. Volunteers will be randomly divided into 4 equal groups by block randomization. The sample size is 32; this study is a double- blinded survey which both volunteers and prescriber don’t know the solutions. The control group will receive placebo. The study is a single center survey. (3)Setting and conduct: All volunteers run 20 meters go and back repeatedly (Shuttle run) till exhausted. (4) Inclusion and exclusion criteria: The volunteers should be in health and don’t have any acute diseases and don’t use any corticosteroid during 3 months and any NSAIDs during last week. The exclusion criteria are any musculoskeletal injury and drinking coffee during study. (5)Intervention: The cases received 10 ml of 120 ml of homeopathic Rhus-tox remedy from 30th centesimal dilution potency which the 1st group received before, 2nd group received after ,and 3rd one received before and after exhaustive exercise and control group received only 10 ml distilled water before shuttle run. (6) Main outcome measures: Blood samples to determine the levels of CPK and LDH in time before the start, immediately after training and 24, 48 and 72 hours after that are taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072319073N2
Registration date:2015-11-18, 1394/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Ali Mazaherinezhad
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
mazaherinezhad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Jahrom
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a homeopathic remedy (Rhus-tox) in the prevention and treatment of delayed onset muscle soreness (DOMS) after an exhaustive exercise
Public title
The effect of a homeopathic remedy on muscle soreness after exhaustive exercise
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lack of acute disease; don't use of corticosteroid medication in the last three months; Do not use of NSAIDs in the last week.
Exclusion criteria: Athletes don't wanting to continue study; injury during exercise; use of coffee during the study.
Age
From 19 years old to 30 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization will be used in the our study for randomizing the volunteers in four equal groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jahrom University of Medical Sciences
Street address
Islamic Azad University of Jahrom, Ostad Motahary St., Jahrom, Fars province
City
Jahrom
Postal code
Approval date
2015-07-15, 1394/04/24
Ethics committee reference number
IR.JUMS.REC.1394.044
Health conditions studied
1
Description of health condition studied
Delayed onset Muscle Soreness
ICD-10 code
---
ICD-10 code description
---
Primary outcomes
1
Description
Blood levels of CPK
Timepoint
Immediately before and after intervention and 24, 48 and 72 hour after that
Method of measurement
blood sampling
2
Description
Blood levels of LDH
Timepoint
Immediately before and after intervention and 24, 48 and 72 hour after that
Method of measurement
blood sampling
Secondary outcomes
1
Description
---
Timepoint
---
Method of measurement
---
Intervention groups
1
Description
Intervention group 1: using of 10 ml of 120 ml of homeopathic Rhus-tox that is made by DHU in Germany, remedy from 30th centesimal dilution potency before shuttle run
Category
Prevention
2
Description
control group: receiveing 10 ml distited water before exercise
Category
Placebo
3
Description
Intervention group 2: using of 10 ml of 120 ml of homeopathic Rhus-tox that is made by DHU in Germany, remedy from 30th centesimal dilution potency after exercise
Category
Prevention
4
Description
Intervention group 3: using of 10 ml of 120 ml of homeopathic Rhus-tox that is made by DHU in Germany, remedy from 30th centesimal dilution potency before and after exercise
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Jahrom
Full name of responsible person
Ali asghar Sarvi
Street address
Islamic Azad University of Jahrom, Ostad Motahary St., Jahrom, Fars province
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Jahrom
Full name of responsible person
Dr. Kazoos Ayazpour
Street address
Islamic Azad University of Jahrom, Ostad Motahary St., Jahrom, Fars province
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University of Jahrom
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
Islamic Azad University of Jahrom
Full name of responsible person
Ali Asghar Sarvi
Position
Master of Science
Other areas of specialty/work
Street address
Islamic Azad University of Jahrom, Ostad Motahary St., Jahrom, Fars province