The effect of topical chamomile herbal product on the symptoms of patients with leg cramps in comparison with standard treatment: a double-blind clinical trial
Investigating the effect of chamomile topical product on the severity of symptoms of people with muscle cramps
Design
This study is a double-blind randomized clinical trial study with a control group and a parallel design, which is conducted in the third phase of the trial on 64 people with muscle cramps in the leg area.
Settings and conduct
Every person who meets the criteria for entering the study is evaluated by an Iranian medical specialist using the VAS tool in the first visit (before the start of the study) and subsequent visits (after the start of the intervention). They are evaluated daily and up to a score of less than four in the VAS tool. Referrals to the health school of Babol University of Medical Sciences, Rouhani Hospital Clinic are examined. Chamomile product and diclofenac gel in a single form, with the same label and the same smell and color (with the addition of color and essential oil) by a pharmaceutical specialist in the herbal laboratory. Medicines will be prepared by the Faculty of Iranian Medicine in Babol. The only person who knows the nature of drugs is the pharmacist who makes the drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Men and women aged 20 to 60 years
2. Presence of pain with a vas score greater than six
Exclusion:
1. Lack of full assessment to monitor the treatment process
2. Lack of satisfaction during treatment
3. The presence of underlying diseases related to cramps
Intervention groups
1. The intervention group includes people with muscle cramps in the leg area who receive topical chamomile products.
2. The comparison group includes people suffering from muscle cramps in the leg area, receiving 1% diclofenac gel.
Main outcome variables
Treatment duration, pain index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046009N7
Registration date:2023-01-09, 1401/10/19
Registration timing:prospective
Last update:2023-01-09, 1401/10/19
Update count:0
Registration date
2023-01-09, 1401/10/19
Registrant information
Name
Seyyed Ali Mozaffarpur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4728
Email address
dr.mozaffarpur@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical chamomile herbal product on the symptoms of patients with leg cramps in comparison with standard treatment: a double-blind clinical trial
Public title
The effect of topical chamomile herbal product on the symptoms of patients with muscle cramps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 20 to 60 years
Presence of muscle cramp in the gastrocnemius muscle
The presence of pain with a vas score greater than six
Exclusion criteria:
Lack of complete evaluation to monitor the treatment process
Lack of satisfaction during treatment
The presence of underlying diseases related to cramps
Using other painkillers
Performing procedures that lead to the improvement of muscle cramps
History of recurrent cramps without clear cause
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the permuted block randomization method. The size of the blocks is 4 and the ratio of drug to control (diclofenac gel) in each group is equal to (1:1).
In each block, random permutations of 4 combinations of chamomile formulation and diclofenac gel are considered. Random sequence generation will be done by the design methodologist.
In order to hide the treatment process, random codes are written on the boxes containing medicine (chamomile product/diclofenac) and after assigning the medicine to the patients, the corresponding code is recorded on the patients' files. The opening of the codes will be done after the end of the study. In case of side effects, the code of that medicine will be opened.
Blinding (investigator's opinion)
Double blinded
Blinding description
Chamomile product and diclofenac gel in a single form, with the same label and the same smell and color (with the addition of color and essential oil) will be prepared by a pharmaceutical specialist in the medicinal plant laboratory of the Faculty of Iranian Medicine in Babol. The only person who knows the nature of drugs is the pharmacist who makes the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical sciences, Sargord Ghasemi avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4718647745
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.205
Health conditions studied
1
Description of health condition studied
muscle cramp
ICD-10 code
R25.2
ICD-10 code description
Cramp and spasm
Primary outcomes
1
Description
pain index
Timepoint
The VAS measurement is measured before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID.
Method of measurement
Pain intensity measurement using VAS tool
2
Description
Duration of treatment
Timepoint
VAS is measured before the intervention and on even days after the start of the intervention, and the examination of the pain index continues until the day it reaches the number 4 or the change rate of 1.7 based on the MCID.
Method of measurement
Pain intensity measurement using VAS tool
Secondary outcomes
1
Description
redness
Timepoint
Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID.
Method of measurement
By patient report or evaluator observation
2
Description
Itching
Timepoint
Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID.
Method of measurement
By patient report or evaluator observation
3
Description
swelling
Timepoint
Measurements are taken before the intervention and on even days after the start of the intervention, and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID.
Method of measurement
By patient report or evaluator observation
Intervention groups
1
Description
Chamomile topical product (combination of chamomile oil and wax made in the laboratory of the Iranian Faculty of Medicine) in the amount of one knuckle every eight hours is used topically on the leg muscles and the VAS index, before the intervention and on even days after The start of the intervention is measured and the treatment continues until the pain index reaches 4 or a change of 1.7 based on the MCID.
Category
Treatment - Drugs
2
Description
1% diclofenac gel of Soban company is used topically on the calf muscles in the amount of one knuckle every eight hours, and the VAS index is measured before the intervention and on even days after the intervention, and the treatment is continued until the day the pain index is reached. Continued to number 4 or a rate of change of 1.7 based on MCID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roohani Hospital
Full name of responsible person
Seyyed Ali Mozaffarpur
Street address
Roohani Hospital, Babol University of Medical Sciences, Ganjafrooz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4728
Email
Seyyedali1357@gmail.com
2
Recruitment center
Name of recruitment center
Health College of Iranian Medicine, Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Street address
Health College of Iranian Medicine,, , Babol University of Medical Sciences, Shahid Keshvari Square, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4728
Email
Seyyedali1357@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 4728
Email
dr.mozaffarpur@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 4728
Email
dr.mozaffarpur@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 4728
Email
dr.mozaffarpur@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document