Evaluation of effect of hydroalcoholic extract of Portulaca oleracea on thyroid hormones in hyperthyroidism
Design
This clinical trial was performed on 50 patients, divided into two groups of 25, including a control group and parallel groups. This study is Double-blind and block randomization method is used.
Settings and conduct
The field of work is clinical - internal. This study is performed in the Tohid Hospital in Sanandaj. Patients, physicians, and nurses who evaluate the outcomes will be blind to the groups studied.
Intervention group: hydroalcoholic extract of Portulaca oleracea, oral capsule, 400 mg, Three times a day for two months with standard treatment Control group: placebo containing starch, oral capsule, 400 mg, OThree times a day for two months with standard treatment
Main outcome variables
Serum TSH levels; Serum T4 levels; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190415043279N5
Registration date:2020-07-11, 1399/04/21
Registration timing:prospective
Last update:2020-07-11, 1399/04/21
Update count:0
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of hydroalcoholic extract of Portulaca oleracea on thyroid hormones in hyperthyroidism
Public title
Assessment of the effect of Portulaca oleracea on hyperthyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recently diagnosed hyperthyroid patients
Exclusion criteria:
Pregnancy
Children
Cardiovascular disease
Ophthalmopathy
Thyroiditis
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive (Capsule containing hydroalcoholic extract of Portulaca oleracea) and the other will receive placebo. Individuals are the randomization unit, making a random sequence is by using statistical software (WinPepi11.0). Allocation concealment is by assigning unique codes
Blinding (investigator's opinion)
Double blinded
Blinding description
All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.MUK.REC.1398.092
Health conditions studied
1
Description of health condition studied
Hyperthyroidism
ICD-10 code
E05.9
ICD-10 code description
Thyrotoxicosis, unspecified
Primary outcomes
1
Description
Serum TSH levels
Timepoint
Measurement of TSH levels before the intervention and two months later
Method of measurement
ELISA
2
Description
Serum T4 levels
Timepoint
Measurement of T4 levels before the intervention and two months later
Method of measurement
ELISA
3
Description
Serum T3 levels
Timepoint
Measurement of T3 levels before the intervention and two months later
Method of measurement
ELISA
4
Description
Body Mass Index
Timepoint
Measurement of BMI before the intervention and two months later
Method of measurement
According to the BMI formula (BMI = (weight in kilograms) divided by (Height in meters squared))
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule containing hydroalcoholic extract of Portulaca oleracea plant at dose of 400 mg three times a day for two consecutive months. These oral capsules of hydroalcoholic extract of Portulaca oleracea plant are prepared by a reputable pharmacist.
Category
Placebo
2
Description
Control group: Placebo in capsules at dose of 400 mg three times a day for two consecutive months. These placebo oral capsules contain starch and are prepared by a reputable pharmacist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Shahnaz Ghafouri
Street address
Tohid Hospital, Geriashan Ave
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3366 4645
Email
drghafoorish76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shahnaz Ghafouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
drghafoorish76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shahnaz Ghafouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
drghafoorish76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shahnaz Ghafouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
drghafoorish76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available