Study the effect of simultaneous consumption of a therapeutic soup and marshmallow flower tea on fasting blood glucose, body mass index and quality of life in patients with type 2 diabetes: a clinical trial
Determine the the effect of simultaneous consumption of a therapeutic soup and marshmallow flower tea on fasting blood glucose, body mass index and quality of life in patients with type 2 diabetes: a clinical trial
Design
This study is a Phase 2 clinical trial investigating the efficacy of a formulated soup and a marshmallow flower tea on fasting glucose in patients with type 2 diabetes mellitus. The study is performed without control group. The sample size is 60 peoples.
Settings and conduct
1. Patients with type 2 diabetes referring to endocrine clinic of Bahonar Hospital of Karaj are identified.
2. Patients who have a fasting blood sugar in the range of 130 - 200 meeting the other criteria of inclusion criteria, and singing a consent form to participate in the project, will be enrolled.
3. Patients perform routine tests at the beginning of the study, if adjust to inclusion criteria, their height and weight are measured, complete a quality of life questionnaire. Patients undergoing therapeutic intervention, and get to know how to use soups, marshmallow flowers and olive oil. Four weeks after participating in the intervention, measuring the parameters mentioned above are repeated again. The plan ends.
Participants/Inclusion and exclusion criteria
Major inclusion Criteria: FBS more than 130 and less than 200 mg/dl
Major Exclusion Criteria: Having Cr. more than 3 mg/dl, Insulin Therapy, Evidence of Serious Damage to Critical Organs.
Intervention groups
Intervention consisted of administration of 200 cc soup as a starter before breakfast and dinner and a tea made of 1 tablespoons of marshmallow flower per cup of boiling water using after breakfast and dinner.
Main outcome variables
Fasting Blood Glucose, Body Mass Index, Quality of life questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131115015408N3
Registration date:2019-08-28, 1398/06/06
Registration timing:prospective
Last update:2019-08-28, 1398/06/06
Update count:0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Anahita Ghourchian
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Country
Iran (Islamic Republic of)
Phone
+98 26 3463 5198
Email address
dr.anahitaghourchian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of simultaneous consumption of a therapeutic soup and marshmallow flower tea on fasting blood glucose, body mass index and quality of life in patients with type 2 diabetes: a clinical trial
Public title
Study the effect of a therapeutic soup and marshmallow flower tea on diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FBS more than 130 & less than 200 mg/dl
Exclusion criteria:
Any patient who uses insulin therapy.
Any patient who has Cr. more than 3 mg/dl
Any patient who has red alarms mentioning serious organ damage.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics on Research Committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Scienses, North Taleghani Blvd,Taleghani Square, Karaj, Iran.
City
karaj
Province
Alborz
Postal code
3186947535
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.ABZUMS.REC.1398.055
Health conditions studied
1
Description of health condition studied
diabetes type 2
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Blood Biochemistry Test
2
Description
Body Mass Index
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Metric Scale and Digital Weighing Scale of clinic
3
Description
Quality of Life Score of the World Health Organization Quality of Life Questionnaire: HOQOL-BREF
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire: HOQOL-BREF
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using 200 cc of therapeutic soup as a starter, before breakfast and dinner and a tea of 1 teaspoon of marshmallow flower put in 150 cc boiled water after breakfast and dinner. Duration of intervention is 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Emam Ali Polyclinic, Endocrinology Clinic