Evaluation the effect of thyrophyte herbal composition on the weight of patients with primary hypothyroidism
Design
This study is a Randomized clinical trial, containing intervention and control groups with parallel groups and triple-blind. The random allocation sequence conduct by using the random numbers table and randomization.com site. The method of allocation concealment is sealed envelope. Patients, researcher and analyzer are unaware of the individuals assigned to the groups. The sample size is 40 people in each group.
Settings and conduct
80 primary hypothyroid patients with overweight and eligibility are selected by the endocrinologist from the endocrinology and metabolism clinic of Ghaem Hospital. Demographics, history , weight of patients are registered . tests (thyroid hormones, lipid profile, fasting sugar) are requested. WHO Quality of Life Questionnaire and Beck Depression Questionnaire are completed by patients. they are randomly divided into two parallel groups of intervention and control and enter the study for 8 weeks. Weight measurement, tests and questionnaires are also done at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Age: 20 to 65 years, Patients known to have primary hypothyroidism by an endocrinologist, Hypothyroid patients with overweight or obesity whose weight has not been controlled with levothyroxine.
Exclusion criteria :
Uncontrolled systemic diseases
Any diet for weight loss during the study and 3 months before arrival
Take a vitamin supplement at least three months before or during the study
Patient dissatisfaction with continued cooperation
Pregnancy
Lactation
Intervention groups
Intervention group : levothyroxine and herbal composition (4.5 g / day in 6 capsules 750 mg)
Control group : levothyroxine and placebo capsule
Main outcome variables
Weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210101049909N1
Registration date:2021-06-18, 1400/03/28
Registration timing:prospective
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Najme Javidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 0995
Email address
javidin9711@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of thyrophyte herbal composition on the weight of patients with primary hypothyroidism
Public title
The effect of thyrophyte herbal composition on the weight of patients with primary hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 20 to 65 years
Patients known to have primary hypothyroidism by an endocrinologist
Hypothyroid patients with overweight or obesity whose weight has not been controlled with levothyroxine
Exclusion criteria:
Uncontrolled systemic diseases
Any diet for weight loss during the study and 3 months before arrival
Take a vitamin supplement at least three months before or during the study
Patient dissatisfaction with continued cooperation
Pregnancy
Lactation
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into Intervention and control groups in blocked
randomization model by using the random numbers table and randomization.com site. The method of allocation concealment is sealed envelope .
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researcher and analyzer are unaware of the individuals assigned to the intervention and control group. Only the sample assignor to the groups is aware of the control and intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad Univercity Of Medical Sciences, University StreetThe Ethics Committee of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.MUMS.REC.1400.037
Health conditions studied
1
Description of health condition studied
Hypothyroidy
ICD-10 code
(E00-E90)
ICD-10 code description
Ectopic endocrine tissue or hyperfunction and hypofunction of endocrine glands associated with neoplasms and other conditions classified elsewhere
Primary outcomes
1
Description
Weight
Timepoint
Before and after intervention
Method of measurement
To measure weight, calculate the ratio of weight in kilograms to height squared in meters (body mass index) and calculate the ratio of waist to hip in centimeters (WHR) using weight and tape meters.
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before and after intervention
Method of measurement
By blood test in mg/dl
2
Description
Fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
By blood test in mg/dl
3
Description
Thyroid hormone (TSH, FT4, T3)
Timepoint
Before and after intervention
Method of measurement
By blood test in ng/dl
4
Description
Depression score on Beck Depression questionnaire
Timepoint
Before and after intervention
Method of measurement
Beck Depression questionnaire
5
Description
Quality of Life score on WHO Quality of Life Questionnaire
Timepoint
Before and after intervention
Method of measurement
WHO Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: They receive levothyroxine and herbal composition (nigella sativa, trachyspermum ammi, citrus aurantifolia) at a dose of 4.5 g daily in 6 capsules of 750 mg for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: They receive Levothyroxine and placebo (Avisel) capsule for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Clinic of Ghaem Hospital
Full name of responsible person
Zahra Mazloum Khorasani
Street address
Ahmadabad Street, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
mazloumz@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Najme Javidi
Position
PhD student of Iranian Traditional and Complementary Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
javidin9711@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Yousefim@mum.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najme Javidi
Position
PhD student of Iranian Traditional and Complementary Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
javidin9711@mums.ac.ir
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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available