Determination of effect of herbal nasal spray based on Oregano on Migraine headache
Design
Two arm parallel group randomized control clinical trial, double-blind, phase 3.
70 patients, Block Random Allocation.
Settings and conduct
Among patients who come to Persian Medicine clinic of Tehran University, the patients who have migraine headache based on IHS criteria; are informed about the survey and if willing they are clearly informed about the procedure. After informed consent they are randomly entered in drug and placebo groups. A note book is designed for them to enter their headache information in that: the time and duration of headache, analgesic name and number used while headache, probable side effects. Finishing the survey the recorded information are investigated and beside Health-related quality of life tests are calculated as final results.
Participants/Inclusion and exclusion criteria
Entrance criteria:
1. Migraine headache based on IHS
2. 2 to 8 attacks per month with headache days less than 15 per month
3. Onset of headaches no sooner than a year ago
4. No warm brain temperament
5. age between 18 and 65 with onset of headaches sooner than 50 years old
Exclusion criteria:
1. Secondary headache
2. Antipsychotic and antidepressant drug for reasons other than migraine in last 3 months
3. Alcohol or drug abuse
4. Drug sensitivity to the drug in experiment ingredients
5. Fertile women with no contraception
6. Pregnancy and breast feeding
7. using a drug which could affect migraine headache during last week
8. drug overuse based on IHS criteria
9. Severe physical or psychological disease
Intervention groups
Drug and placebo spray
Main outcome variables
Number of Migraine headache attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220601055051N1
Registration date:2023-02-03, 1401/11/14
Registration timing:prospective
Last update:2023-02-03, 1401/11/14
Update count:0
Registration date
2023-02-03, 1401/11/14
Registrant information
Name
Jila Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4535
Email address
j_n_30@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an herbal nasal spray (an Iranian traditional medicine drug) based on oregano on migraine: A randomized, double-blinded, clinical trial
Public title
Effect of Oregano nasal spray on migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine based on IHS criteria
2 to 8 migraine attack in a month with less than 15 days headache a month and with at least 48 hours intervals
Onset of headaches less than one year ago
No warm brain temperament
18 to 65 years old with headache onset no later than 50 years old
Exclusion criteria:
Secondary headaches
Regular use of antipsychotic or antidepressant drugs during last 3 months for reasons other than migraine
Alcohol or drug abuse
Drug sensitivity to the drug ingredients
Fertile women with no contraception
Pregnancy and breast feeding
consuming drugs affecting migraine headache or interacting with drug ingredients during last week
Analgesic overuse based on IHS criteria
Severe physical or psychologic disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block Random Allocation
Two groups A and B randomly are allocated to intervention and control groups and are again randomly used in quadruple groups each with two A and two B groups arranged in all different possible arrangement that is: AABB, BBAA, ABAB,BABA,ABBA,BAAB
A and B are in sealed envelope and handed to patients; and so they are randomly entered in two groups .
Randomization unit is individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
The procedure is clearly explained to the patients and then they are given the drugs while they have no idea which drug, the real or the placebo is given to them; so patients are blind. The investigator who hands in the drugs to the patients does not know which drugs are real and which are placebos; so the investigator is blind, too.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
TUMS research ethics committe
Street address
sixth floor, Ghods st., Keshavarz Bulvard
City
Tehran
Province
Tehran
Postal code
research@tums.ac.ir
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.580
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43
ICD-10 code description
G43.0Migraine without aura [common migraine]
Primary outcomes
1
Description
Number of migraine headache attacks per month
Timepoint
Three times with one month intervals
Method of measurement
Number of attacks with at least 48 hours of freedom from headache between migraine attacks
Secondary outcomes
1
Description
Headache severity
Timepoint
Tree times with one month intervals
Method of measurement
Four point verbal scale
2
Description
Number and name of analgesics used
Timepoint
Three times with one month intervals
Method of measurement
Recording the name and the number of analgesics used in one month
3
Description
Health related quality of life
Timepoint
Three times with one month intervals
Method of measurement
Sf 36 & hit 6 questionaire
Intervention groups
1
Description
Intervention group: herbal nasal spray based on oregano- three times a day one puff each nasal orifice
Category
Treatment - Drugs
2
Description
Control group: placebo nasal spray-three times a day one puff each nasal orifice
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran medical University Persian medicine clinic
Full name of responsible person
Dr Meysam Shirzad
Street address
Ahmadieh Persian medicine clinic, Tabriz St., North sarparast St., Talrghani St., Felestine Square.