x

We are happy to announce that all trial registrations will now be issued DOIs (digital object identifiers). For more information, see here.
The effects of Boswellia serrata gum resin on the blood glucose and lipid profile of diabetic patients: A double-blind randomized placebo-controlled clinical trial
Last registered on October 05, 2015

Pre-Trial

Trial Information
General Information
Title
The effects of Boswellia serrata gum resin on the blood glucose and lipid profile of diabetic patients: A double-blind randomized placebo-controlled clinical trial
RCT ID
AEARCTR-0000898
Initial registration date
October 05, 2015
Last updated
October 05, 2015 4:41 PM EDT
Location(s)
Primary Investigator
Affiliation
Iran University of Medical Sciences
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2014-03-01
End date
2014-12-01
Secondary IDs
Abstract

Aim:: Regarding traditional use of Boswellia serrata gum resin and known pharmacological effects of this gum in diabetes, we evaluated anti-hyperglycemic and lipid lowering effects of Boswellia serrata gum resin in type 2 diabetic patients in a double blind randomized placebo-control trial.
Methods and materials: Fifty six diabetic patients were randomly allocated to two groups who received the boswellia serrata gum resin or placebo capsule. The fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c) as primary outcome measures and total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride and insulin level as secondary outcome measures were measured before and 8 weeks after the intervention.
External Link(s)
Registration Citation
Citation
Mehrzadi, Saeed. 2015. "The effects of Boswellia serrata gum resin on the blood glucose and lipid profile of diabetic patients: A double-blind randomized placebo-controlled clinical trial." AEA RCT Registry. October 05. https://doi.org/10.1257/rct.898-1.0.
Former Citation
Mehrzadi, Saeed. 2015. "The effects of Boswellia serrata gum resin on the blood glucose and lipid profile of diabetic patients: A double-blind randomized placebo-controlled clinical trial." AEA RCT Registry. October 05. https://www.socialscienceregistry.org/trials/898/history/5517.
Experimental Details
Interventions
Intervention(s)
The enrolled patients were randomly assigned to receive Boswellia serrata gum capsule (n=27) as the intervention group and placebo capsule (n=29). Patients received Boswellia serrata gum 250 mg capsules or placebo capsules twice daily after meal for 8 weeks. Consumption of conventional oral hypoglycemic agents was continued in two groups simultaneously.
Intervention Start Date
2014-03-01
Intervention End Date
2014-10-01
Primary Outcomes
Primary Outcomes (end points)
The fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c) as primary outcome measures and total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride and insulin level as secondary outcome measures were determined at the baseline and 8 weeks after the intervention in both groups. Blood samples were drawn after an overnight (12h) fasting and sent to hospital’s central laboratory. All the blood sample parameters were measured by using commercially available kits in hospital’s central laboratory.
For final biochemical tests, when patients were blind about the results, they were asked to answer two 5-point rating scale questions ranging from 0 to 4. It was about the effectiveness and general satisfaction with treatment (0: none; 1: mild; 2: moderate; 3: potent; 4: very potent) (Matthys et al., 2003).
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The trial is a two-arm, double-blind randomized placebo-controlled clinical trial using a parallel design with a 1:1 allocation ratio. There was no change in methods after trial commencement.
Experimental Design Details
Randomization Method
Fifty six eligible patients were randomized after signing the consent form in two parallel groups (Boswellia serrata gum capsule as the intervention group and placebo group) by the investigator. The randomized list was generated using Microsoft Excel with a block randomization style, as previously shown (Kim and Shin, 2014). The investigator, drug deliverers and statisticians were blind to the allocation of the patients. Moreover, due to the same shape and size of the intervention and placebo capsules, the patients were blind to the drug allocation.
Randomization Unit
individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
0
Sample size: planned number of observations
60 patients
Sample size (or number of clusters) by treatment arms
30
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IRB Approval Date
IRB Approval Number
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers