Protocol summary

Summary
- The present study was designed to investigate the efficacy of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients.108 patients aged between 40 to 60 years, with confirmed type II diabetes (fasting blood glucose above 150-250 mg/dl and HbA1c 7.5-10% taking antidiabetic drug such as Metformin or Glibenclamid that signed the written informed consent will be selected. The patients will continue their standard anti-diabetic therapy without any change during the study. All patients who suffering from severe kidney, liver, heart and pulmonary diseases, hypersensitivity to any drug, foot ulcer or gangrene, depression and previous myocardial infarction, active cancer or previous cancer during the last 5 years, alcoholic or cigarette smoker, pregnant and breast feeding patients will be excluded. The patients will be randomly allocated into one of three groups. Two groups will receive 150 and 300 mg Aloe Vera as capsules, respectively, two times daily and third group will receive placebo capsules which are the same as true drugs. Fasting blood glucose, glycosilated hemoglobin, total cholesterol, LDL, HDL cholesterol, triglyceride, creatinine, SGOT and SGPT will be measured at the beginning and after two months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706161157N2
Registration date: 2009-04-13, 1388/01/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2009-04-13, 1388/01/24
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahad Daneshgahii and Shaheed Seduqi medical college Yazd Yniversity
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-04-22, 1389/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients, A double – blind, randomized, placebo controlled trial
Public title
The effect of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients, A double – blind, randomized, placebo controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 40 to 60 years, confirmed type II diabetes at least for two years with fasting blood glucose above 150-250 mg/dl taking Metformin or Glibenclamid, HbA1c 7.5-10%, singing the written informed consent. Exclusion criteria: insulin therapy, infectious diseases, severe kidney, liver, heart, or pulmonary disease, hypersensitivity to any drug, foot ulcer or gangrene, major depressive disorders, previous myocardial infarction, active cancer or previous cancer during the last 5 years, alcohol consumption, cigarette smoking, pregnancy, and breast feeding.
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 108
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
Avicenna Research Institute of Academic Center for Education Culture
Street address
Shaheed Beheshti University, Shaheed Chamran Highway
City
Tehran
Postal code
1177-19615
Approval date
empty
Ethics committee reference number
492/51/29 گ ي

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting blood glucose
Timepoint
Baseline and after one and two months
Method of measurement
Glucose oxidase method.

2

Description
Glycosylated hemoglobin
Timepoint
Baseline and after two months
Method of measurement
HPLC method

Secondary outcomes

1

Description
SGOT
Timepoint
Baseline and after two months
Method of measurement
SGOT level in fasting blood sample by DGKG enzymatic method

2

Description
SGPT
Timepoint
Baseline and after two months
Method of measurement
SGPT level in fasting blood sample by DGKG enzymatic method

3

Description
Creatinin
Timepoint
Baseline and after two months
Method of measurement
The fasting blood Creatinin level by JAPH enzymatic method

4

Description
Cholesterol
Timepoint
Baseline and after two months
Method of measurement
Fasting blood Cholesterol level by enzymatic oxidase method.

5

Description
LDL
Timepoint
Baseline and after two months
Method of measurement
Fasting blood LDL level by CDC designated comparison method.

6

Description
HDL
Timepoint
Baseline and after two months
Method of measurement
Fasting blood HDL level by enzymatic oxidase method

7

Description
Triglyceride
Timepoint
Baseline and after two months
Method of measurement
Fasting blood Triglyceride level by enzymatic oxidase method

Intervention groups

1

Description
Aloe vera jell powder 150 mg in capsule two times a day for two months
Category
Treatment - Drugs

2

Description
Aloe vera jell powder 300 mg in capsule two times a day for two months
Category
Treatment - Drugs

3

Description
placebo 150 mg in capsule two times a day for two months
Category
Placebo

4

Description
placebo 300 mg in capsule two times a day for two months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetic Research Center
Full name of responsible person
Dr M. Afkhami
Street address
Afshar Hospital
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahad Daneshgahi
Full name of responsible person
Haji Tarverdi
Street address
Jahad Daneshgahi, Enghelab St.
City
Tehran
Grant name
صبر زرد 25718-20-29
Grant code / Reference number
1461-33
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahad Daneshgahi
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
Institute of Medicinal Plants, ACECR
Full name of responsible person
Fallah Huseini Hassan
Position
Ph.D.
Other areas of specialty/work
Street address
Jahad daneshgahi research society, Kavosh Research town, Tehran-Qazvin Highway
City
Karaj
Postal code
31375369
Phone
+98 261476401019
Fax
fallah@imp.ac.ir
Email
huseini_fallah@yahoo.com
Web page address
www.imp.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Medicinal Plants, ACECR
Full name of responsible person
Hassan Fallah Huseini
Position
Ph.d.
Other areas of specialty/work
Street address
Jahad daneshgahi research society, Kavosh Research town, Tehran-Qazvin Highway
City
karaj
Postal code
31375369
Phone
+98 261476401019
Fax
+98 26 1476 4021
Email
fallah@imp.ac.ir huseini_fallah@yahoo.com
Web page address
www.imp.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Institute of Medicinal Plants, ACECR
Full name of responsible person
Hassan Fallah Huseini
Position
PhD
Other areas of specialty/work
Street address
Jahad daneshgahi research society, Kavosh Research town, Tehran-Qazvin Highway
City
karaj
Postal code
31375369
Phone
+98 261476401019
Fax
+98 26 1476 4021
Email
fallah@imp.ac.ir / huseini_fallah@yahoo.com
Web page address
www.imp.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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