Investigation of anti-inflammatory effect of Boswellia resin extract on inflammatory factors in Alzheimer`s patients
Design
Two arm parallel groups randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Trial will be performed in Imam Hossein hospital based on block randomization in double blind manner. Every person who is involved in caring and treatment of patients including proxies, physicians and nurses are masked and investigators are all masked also
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive DSM-IV
Positive NINCDS/ ADRDA
MMSE includes 10-26
No family history of Alzheimer's disease
Hamilton test equal or less than 12 in 17th item
Memory score below 1
BM includes 18-25
No background of peptic ulcer,surgery of digesting system, or haemorrhage of digesting system
No taking NSAIDs drug compounds or systemic corticosteroid during two months, and continuously before research
No alcohol consumption
age range is 55-85
Exclusion criteria: Turning to negative DSM-IV during Boswellia resin extract period
Turning to positive NINCDS/ ADRDA during Boswellia resin extract period
Acute viral, bacterial or severe infectious disease during research
Shahid Beheshti University of Medical Sciences (SBMU)
Country
Iran (Islamic Republic of)
Phone
+98 21 9666 1028
Email address
karima@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-23, 1396/03/02
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
2017-07-05, 1396/04/14
Actual recruitment end date
2018-08-22, 1397/05/31
Trial completion date
2019-02-21, 1397/12/02
Scientific title
The Investigation on the Effect of Boswellia resin Extract on Plasma Levels of inflammatory factors in Patients with Alzheimer’s disease
Public title
The Investigation on the Effect of Boswellia resin Extract on Plasma Levels of inflammatory factors in Patients with Alzheimer’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive DSM-IV
Positive NINCDS/ ADRDA
MMSE includes 10-26
No family history of Alzheimer's disease
Hamilton test is less than or equal to 12 in 17th item
Memory score below 1
BMI includes 18-25
No background of peptic ulcer,surgery of digesting system, or haemorrhage of digesting system
No taking NSAIDs or systemic corticosteroid during previous two months
No alcohol consumption
Age range is 55-85
Exclusion criteria:
Turning to negative DSM-IV during Boswellia resin extract period
Turning to positive NINCDS/ ADRDA during Boswellia resin extract period
Acute viral, bacterial or severe infectious disease during research
Age
From 55 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was designed based on four-sized block randomization. A non-ordering computer sequence list was generated by an epidemiologist. Codes were written on envelopes and medication bottles. Patients allocation and sequencing were done blind.
Following patients assessment by doctor, according to the admission sequence, the envelopes with the same number will be opened. Then according to the bottle code which is written in envelope, bottle will be given to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients allocation and sequencing are done blind.
All staffs who were involved to perform the enrollment, physicians, nurses and investigator team are all masked.
Therefore, nobody knows the intervention is Boswellic resin extract or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences, School of Medicine
At the recruitment day and after intervention period
Method of measurement
ELISA assay kit
2
Description
MMSE (Mini-Mental State Examination) test
Timepoint
At the recruitment day and after intervention period
Method of measurement
MMSE questionnaire (contained 30 question point involved evaluation of attention and calculation, recall, ability to follow simple commands and orientation)
What processes are involved for a request to access data/document
The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in two weeks.