In this study, tablets will be prepared from dry juice of purslane. Efficacy of oral tablets will be evaluated via double-blind placebo-controled clinical trial on appetite decreasing in healthy valunteers after the physicochemical properties assessment. In clinical trial step, healthy and suitable cases were selected according to physical and experimental exams, appetite questionnaire filling and BMI measurement. Volunteers devided into two groups (35 cases in each group). Treatment period is 60 days. In end of study, volunteers condition will be revaluation. Repeated measure ANOVA and t-test determine the changed factors in end of invetigation.
General information
Acronym
Purslane effect on appetite
IRCT registration information
IRCT registration number:IRCT2016030826977N1
Registration date:2016-08-03, 1395/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-03, 1395/05/13
Registrant information
Name
Mehdi Ajdary Tafti
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 6070
Email address
ajdary@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-24, 1395/07/03
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and evaluation of oral tablet from purslane juice and clinical trial on appetite decreasing
Public title
Evaluation of oral tablet from purslane juice and clinical trial on appetite decreasing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a minimum appetite(according to questionairea); age between 20 to 40 years old; healthy volunteers according to physical and laboratory exams; no weight loss in last 3 months; not taking medication for weight loss or appetite depressants. Exclusion criteria: alcoholism; smoking; any chronic or systemic disease; use of any medication for weight loss, metabolic disease such as diabetes, liver or renal failure, chronic inflamatory conditions, malignancy; use of anti-hyperlipidimic medications; weight loss in 3 months ago; age lower than 20 and upper than 40 years old; pregnancy; lactation; history of urinary stone.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Vice Chancellor for research, Shiraz University of Medical Sciences
Street address
Ethic Committee in Medical Research, Vice Chancellor for research, 7th floor, Central building of Shiraz University of Medical sciences, Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.SUMS.REC.1395.9
Health conditions studied
1
Description of health condition studied
apepetite
ICD-10 code
Y57.0
ICD-10 code description
Appetite depressants [anorectics]
Primary outcomes
1
Description
Appetite
Timepoint
In first day of study and then monthly for two months (days: 1, 30, 60)
Method of measurement
Questionnaire(DEBQ)
Secondary outcomes
1
Description
Body mass index (BMI)
Timepoint
Every 2 mounths (first day and 60th day)
Method of measurement
According to height and weight
Intervention groups
1
Description
Administration of a tablet containg 500 mg dry juice of purslane 3 times a day before deal with a glass of water for 2 months besides conventional diet for weight loss.
Category
Treatment - Drugs
2
Description
Placebo administration (tablet), 3 times a day before meal with a glass of water for two months besides conventional diet for weight loss.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Dr. Siavash Babagaafari
Street address
Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of shiraz university of medical scinces
Full name of responsible person
Dr Basir Hashemi
Street address
Resaerch vice, 7th floor, central building of shiraz university of medical sciences, zand street. shiraz
City
Shiraz
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 shiraz university of medical scinces
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
Shiraz university of medical sciences
Full name of responsible person
Dr Mehdi Ajdary Tafti
Position
PhD candidate of traditional pharmacy
Other areas of specialty/work
Street address
Department of traditional pharmacy- school of pharmacy- karafarin street-Akbarabad- Shiraz
City
Shiraz
Postal code
Phone
+98 71 3232 3128
Fax
Email
ajdary@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ajdary Tafti
Position
PhD candidate of Traditional Pharmacy
Other areas of specialty/work
Street address
Department of Traditional Pharmacy, School of Pharmacy, Karafarin st., Akbarabad
City
Shiraz
Postal code
Phone
+98 71 3232 3128
Fax
Email
ajdary@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr Mehdi Ajdary Tafti
Position
PhD candidate of traditional pharmacy
Other areas of specialty/work
Street address
Department of traditional pharmacy-school of pharmacy-Karafarin st-Akbarabad-Shiraz
City
Shiraz
Postal code
Phone
+98 930 563 1109
Fax
Email
ajdary@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)