To evaluate the complementary efficacy of a compound herbal drug (Thymus daenensis, Matricaria chamomilla L. , Achillea santolina & Satureja bachtiarica Bunge) in patients with diabetes type II
To evaluate the efficacy and side effects of using the combination of herbal drug (Thymus daenensis, Matricaria chamomilla L. , Achillea santolina & Satureja bachtiarica Bunge) (Diabetic Capsule) in treatment of diabetic patients as a complementary therapy
Design
Randomized controlled clinical trial with parallel groups and triple blinded.
Settings and conduct
This study is conducting in Fasa and Shiraz and participants, researchers and analyzer are blinded to the study groups
Participants/Inclusion and exclusion criteria
En All the diabetic patients with HgbA1c more than 6.4 who are between 30 to 65 years old and have a weight 55 to 100 kg will recruit in this study. Additional inclusion criteria are; not to have any alcohol or drug addiction, have a BMI between 18 to 35 and not to consume any cortone and herbal or chemical anti-diabetic drug.
Intervention groups
This study has 2 drug and 1 control groups. In drug groups; for three months, in addition to the common anti-diabetic drugs: either type 1 capsules of diabetes (each capsule contains aqueous extract of 100 mg of thyme, 100 mg of chamomile, 200 mg of Achillea and 100 mg of Satureja), or type 2 diabetes capsules (Each capsule contains dried hydro-alcoholic extracts of 100 mg Thymus, 100 mg chamomile, 200 mg of Achillea officinalis and 100 mg of Satureja) are prescribed, and to the control group instead of the capsule of diabetes, placebo capsules which contain 500 mg of corn flour are given.
Main outcome variables
FBS; BS2pp; HgbA1c; Cholestrol; HDL; LDL; TG; LFT and gene expression of: PPARγ, IGFBP-2, IGFR, IGF-1 and IR.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140715018490N6
Registration date:2018-11-13, 1397/08/22
Registration timing:registered_while_recruiting
Last update:2018-11-13, 1397/08/22
Update count:0
Registration date
2018-11-13, 1397/08/22
Registrant information
Name
Massih Sedigh Rahimabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 6275
Email address
sedighrm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the complementary efficacy of a compound herbal drug (Thymus daenensis, Matricaria chamomilla L. , Achillea santolina & Satureja bachtiarica Bunge) in patients with diabetes type II
Public title
Effect of compounds (Thymus daenensis, Matricaria chamomilla L., Achillea santolina & Satureja bachtiarica Bunge) on the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of diabetes (FBS>126 mg/dl)
To have a FBS less than 270 and HgbA1c more than 5.6
Age between 30 to 65
Not to have any additional systemic diseases like; liver, renal, rheumatologic diseases or hypertension
Not to consume any anti-diabetic or corticosteroid drugs 2 weeks before the study
Not to drink alcohol or use opium
To have a weight between 55-100
To have a BMI between 18 to 35
Exclusion criteria:
Not agree to participate in the study.
To have a FBS more than 270 mg/dl
Consuming corticosteroid drugs during the study
Presence of any side effects
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
A random table with blocks of 6. In this method; using an existing electronic software such as "https://www.sealedenvelope.com/simple-randomiser/v1/lists", we create a randomized list of 6 blocks for the 3 study groups. In this list, letters A, B, and C as three groups of this study are randomly distributed in groups of 6. And on the basis of this list, medications are given to the patients respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researchers and data analyzer were blinded to the study groups. We made the placebo and therapeutic capsules like each other and labeled them by a letter -from A to C.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comimtte of Fasa University of Medical Sciences
Street address
Ebn-Sina square
City
fasa
Province
Fars
Postal code
86688-74616
Approval date
2639-01-21, 2017/11/01
Ethics committee reference number
IR.FUMS.REC.1396.296
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
At the beginning of intervention, after 4 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
2
Description
HgbA1C
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
3
Description
کلسترول تام
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
4
Description
BS2pp
Timepoint
At the beginning of intervention, after4 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
5
Description
LDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
6
Description
HDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning
Method of measurement
Venous blood sampling
7
Description
SGOT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
8
Description
Alp
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
9
Description
TG
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
10
Description
SGPT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
11
Description
PPARγI gene expression
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
12
Description
IGFBP-2 gene expression
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
13
Description
IGFR gene expression
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
14
Description
IGF-1 gene expression
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
15
Description
IR gene expression
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention.
Method of measurement
Venous blood sampling
Secondary outcomes
1
Description
Satisfaction of patients
Timepoint
3 months after recruitment
Method of measurement
visual analog scale
2
Description
Tolerance
Timepoint
3 months after recruitment
Method of measurement
visual analog scale
3
Description
Temperament
Timepoint
At the beginning of the study
Method of measurement
Questionnaire
4
Description
Drug side effects
Timepoint
3 months after recruitment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: In addition to anti diabetic drugs, a coded bottle containing type 1 diabetic capsules (each capsule containing dried aqueous extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: In addition to anti diabetic drugs, a coded bottle containing type 2 diabetic capsules (each capsule containing dried hydro-alcoholic extract of 100 mg of Thymus, 100 mg of chamomile, 200 mg of Achillea and 100 Mg Satureja), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months.
Category
Treatment - Drugs
3
Description
Control group: In addition to anti diabetic drugs, a coded bottle containing placebo capsules (each capsule containing 500 mg of caramelized corn flour), is given to the patients. This means that: besides their anti diabetic drugs, they should consume 2 other capsules per day (one in the morning and one in the evening) for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Persian Clinic
Full name of responsible person
Jamshidi Neda
Street address
Felestin st.
City
Shiraz
Province
Fars
Postal code
1111111111
Phone
+98 71 3234 0461
Email
n.jamshidi69@gmail.com
2
Recruitment center
Name of recruitment center
Doctor Forough Pour's office
Full name of responsible person
Doctor Forough Pour
Street address
golzar
City
shiraz
Province
Fars
Postal code
22222222
Phone
+98 71 3620 5451
Email
n.jamshidi69@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Fasa University of Medical Sciences, Ebnesina square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?