IRCT | Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD)

Protocol summary

Study aim: 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: Modifying the start time of patient admission
Acronym
IRCT registration information: IRCT registration number: IRCT20220628055302N1

Registration date: 2022-07-23, 1401/05/01

Registration timing: prospective

Last update: 2023-02-14, 1401/11/25

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: 2023-01-28, 1401/11/08
Expected recruitment end date: 2024-01-28, 1402/11/08
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

City

Mashhad

Province

Razavi Khorasan

Postal code

13944-91388
Approval date: 2022-06-11, 1401/03/21
Ethics committee reference number: IR.MUMS.REC.1401.076

Health conditions studied

1

Description of health condition studied: Chronic Obstructive Pulmonary Disease
ICD-10 code: j44.9
ICD-10 code description: Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description: Anxiety score in HADS anxiety subscale questionnaire
Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week
Method of measurement: HADS anxiety subscale questionnaire

2

Description: Anxiety score in Spielberger's Clear and Hidden Anxiety Questionnaire (STAI)
Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week
Method of measurement: Spielberger state anxiety questionnaire

3

Description: CAT score
Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week
Method of measurement: CAT test

Secondary outcomes

1

Description: distance traveled in the 6MWT
Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th
Method of measurement: 6-minute walk test (6MWT)

2

Description: Number of times sitting and getting up in the chair
Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th
Method of measurement: 1-min sit-to-stand test (STST)

3

Description: Blood oxygen saturation (SaO2)
Timepoint: At the beginning and end of each round of the (STST) and (6MWT)
Method of measurement: Pulse oximeter device

4

Description: Pulse rate
Timepoint: At the beginning and end of each round of the (STST) and (6MWT)
Method of measurement: Pulse oximeter device

5

Description: Quality of Life score on WHO Quality of Life Questionnaire (Bref-WHOQol)
Timepoint: Before and after intervention
Method of measurement: WHO Quality of Life Questionnaire

Intervention groups

1

Description: Intervention group: Hydroalcoholic extract of jujube and lemonbalm in the form of capsules 750 mg twice a day for 6 weeks
Category: Treatment - Drugs

2

Description: Control group: placebo(Avisel) capsule for 6 weeks
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Lung Clinic of Imam Reza Hospital

Full name of responsible person

Mahnaz Mozdurian Mahdi Abad

Street address

Imam Reza Hospital, Imam Reza Square, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

91766-99199

Phone

+98 51 3840 0001

Email

Mozdorianmh@mums.ac.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr.Majid Ghayour Mobarhan

Street address

University Street - Gharshi Building of Mashhad University of Medical Sciences - Vice Chancellor for Research and Technology

City

Mashhad

Province

Razavi Khorasan

Postal code

13944-91388

Phone

+98 51 3841 2081

Email

vcresearch@mums.ac.ir

Web page address

http://v-research.mums.ac.ir
Grant name
Grant code / Reference number: 4001898
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Mashhad 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

Mashhad University of Medical Sciences

Full name of responsible person

Samane Mousapoor

Position

resident

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Azadi Square, east door of the university campus, Faculty of Iranian and Complementary Medicine, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

9177899191

Phone

+98 51 3884 8931

Email

mousapours981@mums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr.Roshanak Salari

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Azadi square, university campus, School of Persian and complementary medicine

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948564

Phone

+98 51 3884 8930

Email

SalariR@mums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Samane Mousapoor

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Traditional Medicine

Street address

Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad

City

Mashhad

Province

Razavi Khorasan

Postal code

9177899191

Phone

+98 51 3884 8931

Email

Mousapours981@mums.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: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be 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

Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD)