A review of tension headaches in Iranian medicine and comparison the effects of the of Valerian extraction and placebo on severity and duration of headaches in patients with tension-type headache
Determination of Valeriana Officinalis effect on severity of Tension headache (TH) in comparison with placebo; determination of Valeriana Officinalis effect on duration of Tension headache (TH) in comparison with placebo; determination of Valeriana Officinalis effect on frequency of Tension headache (TH) in comparison with placebo; determination of Valeriana Officinalis effect on disability of Tension headache (TH) in comparison with placebo
Design
Parallel double blind randomised clinical trial with repeated measurement of outcome
Settings and conduct
This double blind randomized clinical trial will be conducted at the Neurological Clinic of the Aria Hospital of Mashhad for one year. All patients aged 18 to 65 suffering headaches and diagnosed by a neurologist based on the ICHD-III criteria, and are under treatment with common medicines and having medical registry can be included in the RCT. After sample size calculation, 110 eligible patients will be recruited and will be assigned randomly to intervention and placebo group. This is a double blind RCT which GP and patients are blinded.
Participants/Inclusion and exclusion criteria
Eligibility criteria
Agreement for participation;
Filling the informed consent form;
Age between 18 and 65 years;
Suffering from tension headache based on ICHD-III criteria;
Exclusion criteria
Suffering uncommon headache or probable headache or other primary and secondary headache; feeling headache with moving the head; history of metabolic disorder or skeleton disorder which cause similar headache; history of trauma; sign of dizziness with unknown cause;
stiffness of the joints, atherosclerosis or advanced arthritis; emotional stress; neurological disorder; taking barbiturates or sedative medications; history of Valeriana Officinalis intake or its products in the past month; pregnancy and lactation; diabetes; hypertension; heart disease; liver and kidney disease, and chronic psychological illness; history of hypotension (with or without medication); history of taking anti-coagulation medications, antiplatelet, heparin, thrombotic agents, opioid analgesics and loperamide.
Intervention groups
The Valeriana Officinalis and placebo capsules, each in cans containing 60 capsules, will be delivered to a specialist for assignment to intervention and control groups; for duration of one month (two capsule per day after dinner). Label B assigned to Valeriana Officinalis cans and A label assigned to placebo cans.
Main outcome variables
Severity of the headache; duration of headache; frequency of headache; side effects; headache severity; disability
General information
Reason for update
Acronym
THV
IRCT registration information
IRCT registration number:IRCT20171203037738N1
Registration date:2018-03-16, 1396/12/25
Registration timing:prospective
Last update:2018-03-16, 1396/12/25
Update count:0
Registration date
2018-03-16, 1396/12/25
Registrant information
Name
Hosein Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 0095
Email address
azizi.h@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A review of tension headaches in Iranian medicine and comparison the effects of the of Valerian extraction and placebo on severity and duration of headaches in patients with tension-type headache
Public title
Effect of Valerian on tension headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete written informed consent
Age between 18 to 65 years
Suffering from common or chronic tension headache based on the International Association Headache (ICHD-III) criteria
Be under treatment with medications
Not completed treatment (for headache)
Informed consent
Exclusion criteria:
Patients with uncommon or probable headache or other primary or secondary headaches
Headache increases with head movement
Metabolic or musculoskeletal disorders that cause similar headache symptoms
History of trauma to the spinal cord
True or false vertigo
Rigidity of the joints, atherosclerosis or advanced arthritis
Emotional stress
Neurological disorders
Taking barbiturates or sedative medications (classic or traditional medicine)
The consumption of valerian or its products in the past month
Pregnancy and lactation
Having underlying disease including diabetes, hypertension, heart disease, liver and kidney disease, and chronic psychological disease
History of hypotension (with or without medication)
Use of anticoagulants, antiplatelet, heparin, thrombotic agents, opioid analgesics and loperamide
Patient headaches improve with taking triptans
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
We will use random digit for randomization. The unit of randomization is each patients. We will use Microsoft Excel for generation of random digits. Also, this is a double blind RCT and patients and practitioners are not aware about the interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and practitioners should be blind about the interventions.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciencs
Street address
Iran University of Medical Sciences, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
IR.IUMS.FMD.REC1396.9321309012
Health conditions studied
1
Description of health condition studied
Tension Headache
ICD-10 code
G44.22
ICD-10 code description
Chronic tension-type headache
Primary outcomes
1
Description
Frequency of headache and disability caused by headache are our main outcomes measures.