To evaluate the efficacy and side effects of using the combination of Trigonella foenum-graecum L and Citrullus colocynthis (L.) (Diabetic Capsule) in treatment of diabetic patients as a complementary therapy
To evaluate the efficacy and side effects of using the combination of Trigonella foenum-graecum L and Citrullus colocynthis (L.) (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 participants, researchers and analyzer are blinded to the study groups.
Participants/Inclusion and exclusion criteria
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 24 to 35 and not to consume any cortone and herbal or chemical anti-diabetic drug.
Intervention groups
For 3 months, in drug group; addition to conventional anti-diabetic drugs, capsules with 40 mg Citrullus colocynthis and 350 mg Trigonella foenum-graecum are administrated 2 times per day. And in control group; addition to conventional anti-diabetic drugs, capsules with 350 mg corn flour are administrated 2 times per day.
Main outcome variables
FBS; BS2pp; HgbA1c; Cholestrol; HDL; LDL; TG and LFT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140715018490N3
Registration date:2018-04-16, 1397/01/27
Registration timing:registered_while_recruiting
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
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
2018-04-04, 1397/01/15
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the efficacy and side effects of using the combination of Trigonella foenum-graecum L and Citrullus colocynthis (L.) (Diabetic Capsule) in treatment of diabetic patients as a complementary therapy
Public title
To evaluate Fenugreek and Bitter apple in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of diabetes (FBS>126 mg/dl)
To have a FBS less than 250 and HgbA1c more than 6.4
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 24 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:
74
More than 1 sample in each individual
Number of samples in each individual:
3
Venous blood (10 cc) for lab data
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomized Table
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 D.
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
2017-09-05, 1396/06/14
Ethics committee reference number
IR.FUMS.REC.1396.219
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
At the beginning of intervention, after 2 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
2
Description
HgbA1C
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
3
Description
Total cholesterol
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
4
Description
BS2pp
Timepoint
At the beginning of intervention, after 2 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
5
Description
LDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
6
Description
HDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
7
Description
SGOT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
8
Description
SGPT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
9
Description
Alp
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Blood sampling
10
Description
TG
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
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: Addition to conventional anti-diabetic drugs, capsules with 40 mg Citrullus colocynthis and 350 mg Trigonella foenum-graecum are administrated 2 times per day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: In this group; addition to conventional anti-diabetic drugs, capsules with 350 mg corn flour are administrated 2 times per day for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Fatemeh Kerdegari
Street address
Taleghani
City
Fasa
Province
Fars
Postal code
12
Phone
+98 71 5331 4076
Email
f.kerdegari@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, Fasa
City
fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
akrami_e@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ghazal II, Paeez st., Pasargad Ave.
City
Shiraz
Province
Fars
Postal code
123456789
Phone
+98 71 3825 6275
Fax
+98 71 1230 9979
Email
sedighrm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ghazal II, Paeez st., Pasargad Ave.
City
Shiraz
Province
Fars
Postal code
123456789
Phone
+98 71 3825 6275
Fax
+98 71 1230 9979
Email
sedighrm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ghazal II, Paeez st., Pasargad Ave.
City
Shiraz
Province
Fars
Postal code
123456789
Phone
+98 71 3825 6275
Fax
+98 71 1230 9979
Email
sedighrm@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data and results of analysis will be published in a paper.
When the data will become available and for how long
After the end of study.
To whom data/document is available
All of those who have access to the article.
Under which criteria data/document could be used
The editor in chief, if necessary.
From where data/document is obtainable
Vice chancellor for research affair of Fasa University of Medical Sciences
What processes are involved for a request to access data/document
Asking from Vice chancellor for research affair of Fasa University of Medical Sciences