Efficacy of Aqueous Extract of Echium Amoenum on Anxiety and Perceived Stress and Onset of Menstruation in Women with Menstruation Retard : Three Blind Randomized Clinical Trial
Determining the effect of Echium Amoenum aqueous extract plant on the level of anxiety, perceived stress and occurrence of menstruation in women with menstruation retard :Three blind randomized clinical trial
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 82 patients. A web-based randomization list was used for randomization.
Settings and conduct
Methods:
Randomly assigning patients to two groups and giving 42 capsules (drug or placebo without informing the research units) for 6 weeks (26). Capsules in a dose of 500 mg (23), (borage flower or corn flour) are prescribed once a day 30 minutes after breakfast. For the random allocation of samples, permutation blocks of 2 and 4 are used. The randomization list is generated by the analyst based on the web, then it is provided to the researcher in sealed and non-transparent envelopes.This study will be triple blind. Patients do not know about the nature of drugs due to the similarity of their appearance. Medicines and placebos are coded A and B and are provided to the project manager ( Outcome assessor ) in the form of 42 capsule packs with the same codes. Determining the groups in the data file will also be provided to the analyst in the form of coding.
Place of study: Gonabad health and treatment centers
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnancy, suffering from underlying diseases and disorders related to the reproductive system, BMI less than 18, use of hormonal, antihypertensive and depressant and herbal drugs, Exclusion criteria: occurrence of side effects related to the use of borage, lowering blood pressure less than 20/10
Intervention groups
The intervention group will receive Echium Amoenum extract. The control group will receive a placebo.
Main outcome variables
Primary outcome: stress and anxiety
Secondary outcome: Menstruation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230417057944N1
Registration date:2023-05-15, 1402/02/25
Registration timing:registered_while_recruiting
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Sakina Nazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nazerisakina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-03, 1402/02/13
Expected recruitment end date
2023-08-04, 1402/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Aqueous Extract of Echium Amoenum on Anxiety and Perceived Stress and Onset of Menstruation in Women with Menstruation Retard : Three Blind Randomized Clinical Trial
Public title
Efficacy of Echium Amoenum on the level of anxiety, perceived stress and occurrence of menstruation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age between 18-40 years
Willingness and informed consent to participate in research
Negative pregnancy test
Menstrual cycle delay according to the average period of each person's menstrual cycle in the last six months
History of postponing menstrual bleeding for intervals of 36 days to 6 months
Exclusion criteria:
Smoking, drugs and alcohol
The existence of underlying medical diseases and disorders related to the reproductive system based on individual statement.
BMI less than 18
Lactation amenorrhea
Suffering from known mental disorders other than stress and anxiety based on the person's statements and scores obtained from the Hamilton Anxiety Rating Scale (HARS) and Cohen's perceived stress questionnaires.
Being allergic to Echium Amoenum
Doing sports professionally
The presence of nutritional disorders such as bulimia nervosa and anorexia nervosa or malnutrition based on the person's statements
Taking hormonal, antihypertensive and depression and herbal medicines
Having primary amenorrhea.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be non-random (available) and for random allocation of samples to each of the intervention and control groups, permutation blocks of 2 and 4 will be used. The randomization list is generated by the analyst based on the web at the following address (www.sealedenvelope.com), then it is provided to the researcher in sealed and non-transparent envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the aqueous extract of Echium Amoenum in the form of 500 mg oral capsules and capsules containing corn flour are used as a placebo. The drug and placebo are packed in the same packages in terms of shape and color and are coded with A and B codes, and in this way the study will be blinded from the point of view of the researcher and the research units.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-04-03, 1402/01/14
Ethics committee reference number
IR.GMU.REC.1402.010
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
3
Description of health condition studied
Oligomenorrhea
ICD-10 code
N91.4
ICD-10 code description
Secondary oligomenorrhea
Primary outcomes
1
Description
Anxiety mean
Timepoint
At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum
Method of measurement
Hamilton Anxiety Rating Scale
2
Description
Perceived Stress mean
Timepoint
At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum
Method of measurement
Cohen perceived stress scale
Secondary outcomes
1
Description
Occurrence of menstruation in a patient with oligomenorrhea or secondary amenorrhea
Timepoint
3-7 days after starting to take the capsule of Echium Amoenum, during the period of taking the medicine, 4 weeks after stopping the capsule
Method of measurement
Questionnaire for recording the daily state of menstruation
Intervention groups
1
Description
Intervention group: People in the intervention group will receive 42 capsules containing the aqueous extract of cow tongue plant in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company Tos Mashhad will be the drug manufacturer.
Category
Treatment - Drugs
2
Description
:Control group: People in the control group will receive 42 capsules containing corn flour in the form of 500 mg oral capsules for 6 weeks (one capsule a day, 30 minutes after breakfast). Gol Elixir Pharmaceutical Company of Tos Mashhad will be the drug manufacturing company.