Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD)
Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Randomization with a table of random numbers and Random Allocation Software.
Settings and conduct
60 patients with chronic obstructive pulmonary disease referred to Imam Reza Hospital's lung clinic, treated with standard drugs, with anxiety without the need for drug treatment, were selected.In the intervention group, 750 mg capsules containing hydroalcoholic extract of jujube and lemon balm are added to the treatment regimen twice a day for 6 weeks; In the control group, capsules containing Avicel are added. First, the level of anxiety will be checked with hospital anxiety questionnaire (HADS) and Spielberger (STAI), respiratory status with physical tests and breathing questionnaire. Questionnaires and tests will be repeated in the 3rd and 6th week. The quality of life questionnaire will be done at the beginning and end of the study.The study is double-blind (researcher and patients) and patients are divided into intervention and control groups by randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 40 to 70 years with confirmed COPD without known anxiety disorder, who have a score of 8 and above based on the HADS questionnaire؛ exclusion criteria: pregnancy and breastfeeding
severe anxiety requiring classical treatment
Known anxiety or mood disorder requiring psychiatric treatment
Intervention groups
Intervention group:Adding jujube and lemonbalm extract in the form of 750 mg capsules twice a day for 6 weeks to medicines.
Control group: adding a placebo capsule (Avisel) for 6 weeks.
Main outcome variables
Anxiety, respiratory symptoms (cough, shortness of breath, sputum)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220628055302N1
Registration date:2022-07-23, 1401/05/01
Registration timing:prospective
Last update:2022-07-23, 1401/05/01
Update count:1
Registration date
2022-07-23, 1401/05/01
Registrant information
Name
samane mousapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3725 3373
Email address
mousapours981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-01, 1401/07/09
Expected recruitment end date
2023-10-01, 1402/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD)
Public title
Evaluation the effect of jujube and lemon balm extracts in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 40 to 70 with COPD, whose disease has been confirmed by a lung specialist
COPD patients who did not have a known anxiety disorder and were not under standard psychiatric treatment, but had a score of 8 or higher based on the HADS questionnaire
People who are satisfied with traditional treatment
Exclusion criteria:
Pregnancy and breastfeeding
A history of severe anxiety that requires classical medical treatment
People who are under the supervision of a psychiatrist or take psychiatric medication due to a known anxiety or mood disorder
People who have severe anxiety in the screening tests will be referred to a psychiatrist for diagnostic evaluation and standard treatment
Suffering from other medical diseases including hypothyroidism
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into Intervention and control groups in blocked randomization model by using the random numbers table and Random Allocation Software. 16 blocks of 4 will be produced and the sequence produced by the design statistician will be placed in opaque sealed envelopes and numbered, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researcher and outcome assessor are unaware of the
individuals assigned to the intervention and control group. Clinical supervisor and sample allocator to the groups are aware
of the control and intervention group.The drug used in both intervention and control groups will be similar in terms of shape and appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad Univercity Of Medical Sciences, University StreetThe Ethics Committee of Mashhad University of Medical Sciences