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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 05, 2015, 4:41 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials