Evaluation the effect of squill oxymel, Traditional Medicine product, in the treatment of chronic obstructive pulmonary disease (COPD) in patients 18 to 60 years old: triple-blind randomized Clinical trial
The purpose of this study is to evaluate the effect of Squill Oxymel in the patients with chronic obstructive pulmonary disease (COPD). The study is a randomized, triple-blind and single-center which will be carried out on 42 patients with stage IIA COPD referred to Imam Khomeini Hospital. Inclusion criteria include: Age 18 to 60 years, patients with GOLD stage IIA COPD who have clinical criteria include: FEV1/FVC less than 0.7 of the predicted and FEV1 between 50% to 80% of the predicted and treated with conventional drugs. Exclusion criteria: Add or remove the drugs that interferes with COPD (such as NSAIDs) and Infections leading to hospitalization. Method: with randomization (blocks), Patients will be divided into 2 groups of 21 people: Intervention Group (Squill Oxymel, Oral Syrup, 10 ml twice a day) and Control Group (placebo, Oral Syrup, 10 ml twice a day). Patients will be treated for 6 weeks. The Primary outcome is the distance traveled in the 6MWT. Secondary outcomes include quality of life and Blood oxygen saturation (SaO2). These changes will be assessed with the quality of life questionnaires St. George (SGRQ) and the 6-minute walk test (6MWT) before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040919912N2
Registration date:2016-09-22, 1395/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Hossein Karegar-Borzi
Name of organization / entity
College of Traditional Medicine of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 8550
Email address
h-karegar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
College of Traditional Medicine of Tehran University of Medical Sciences
Expected recruitment start date
2016-10-16, 1395/07/25
Expected recruitment end date
2017-04-14, 1396/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of squill oxymel, Traditional Medicine product, in the treatment of chronic obstructive pulmonary disease (COPD) in patients 18 to 60 years old: triple-blind randomized Clinical trial
Public title
Evaluation of the effect of squill oxymel In COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 60 years; patients with GOLD stage IIA COPD who have clinical criteria include: FEV1/FVC less than 0.7 of the predicted and FEV1 between 50% to 80% of the predicted; treated with conventional drugs; Lack of pregnancy; Lack of breastfeeding; Lack of the use other herbal medicines; Lack of active peptic ulcer and cardiovascular disease (especially heart block) or renal disease; Not concomitant use of anticoagulant; Non-smoking. Exclusion criteria: Add or remove the drugs that interferes with COPD (such as NSAIDs); Infections leading to hospitalization; the patient's unwillingness to continue treatment.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz Ave., Tehran