This was an experimental double blind randomized controlled trial (RCT) to evaluate the Rheum ribes L. aqueous extract effect on depression in type2 diabetic patients referring to Yazd Diabetes Research Center.
Fifty four patients (40-70 years old) with at least two years of diabetes history and Hb A1c ≤10 but not suffering from other mental diseases under treatment (schizophrenia, obsession compulsive disorder, anxiety), chronic diseases (heart failure, cancer, respiratory failure),chronic kidney and chronic liver diseases and depressed patients admitted to the hospital were selected and assigned into two groups randomly. Randomized block method was used to make assignment random. The intervention group received required medications and 1200 mg aqueous extract of rhubarb daily for six weeks. In the control group patients received required medications and placebo. In each group, Patients were evaluated before the intervention and at the end of the 4th and 6th week by the Hamilton Rating Scale for Depression (HAM-D) and these results were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041018828N3
Registration date:2017-04-24, 1396/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Rheum ribes L. aqueous extract effect on depression in type2 diabetic patients
Public title
Evaluation of Rheum ribes L. aqueous extract effect on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 40 to 70 years; with at least 2 years of being diabetes patient; HbA1c <10%
exclusion criteria: suffering from other mental diseases under treatment; chronic disease (heart failure, cancer,chronic kidney and chronic liver disease); hospitalized patients with depression ; allergy to Rheum ribes L. aqueous
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Bahonar square, Yazd, Iran
City
Yazd
Postal code
8917693571
Approval date
2016-08-14, 1395/05/24
Ethics committee reference number
IR.SSU.REC. 1395.66
Health conditions studied
1
Description of health condition studied
Type 2 diabete
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, The end of the fourth week, The end of the Sixth week
Method of measurement
Hamilton Rating Scale for Depression
Secondary outcomes
1
Description
HbA1C
Timepoint
Before the intervention, After intervention
Method of measurement
Blood Test
Intervention groups
1
Description
The intervention group received required medications and 1200 mg aqueous extract of rhubarb daily for six weeks.
Category
Treatment - Drugs
2
Description
In the control group patients received required medications and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Street address
Talar Honar alley, Bahonar square, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
PhD
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+382 03865
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Position
Endocorinologist, Assistant Professor
Other areas of specialty/work
Street address
Talare Honar Alley, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+372 80215
Fax
Email
drmasoudrahmanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Nekoukar
Position
Student Doctor of Pharmacy
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
Phone
00
Fax
Email
n.nekoukar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)