Protocol summary

Study aim
Determination of the effect of ginger diet on refractory symptoms in patients with hypothyroidism
Design
A randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
Sixty hypothyroid patients and 60 normal TSH population with inclusion criteria were divided into two groups of 30 with A and B using block 4 randomization method. Demographic information is recorded. Blood samples are taken for TG, CHOL, FBS, TSH tests. ThySRQ questionnaire is completed for all patients.Group A and C were then given ginger capsules (500 mg twice daily) and group B and D received placebo capsules for one month.After one month of treatment, each patient is re-evaluated by performing ThySRQ tests and recording data.
Participants/Inclusion and exclusion criteria
A patient with controlled thyroid dysfunction, who still complains of symptoms Serum TSH level should be between .5 -5 units Informed consent of patients to participate in the study Age range 20-60 years Body mass index 19-35. Pregnancy 2. Co-infection with other thyroid diseases 3. Any type of malignancy 4. Experience the courage of ginger 5. Liver and kidney failure 6. Diseases related to the hypothalamic pituitary pathway 7. With malabsorption disorders such as celiac disease, IBD, atrophic gastritis 8. Concomitant use of drugs such as phenobarbital, phenytoin, carbamazepine, rifampin, glucocorticoid, estrogen, raloxifene 9- caused by severe mental illness 10- Use warfarin and statins 11. Purpose of pregnancy
Intervention groups
We have two groups of 60 low-functioning thyroid and a normal population, each divided into two subgroups of 30 each, given one capsule group containing ginger powder and the other with a placebo
Main outcome variables
Help control resistant symptoms in hypothyroid patients undergoing thyroid hormone replacement therapy, such as feeling weak, coldness, menstrual disorders, constipation, depression ...

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191231045961N1
Registration date: 2020-02-06, 1398/11/17
Registration timing: prospective

Last update: 2020-02-06, 1398/11/17
Update count: 0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
hamide ashraf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 3667
Email address
stud2391929048@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-17, 1399/01/29
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of ginger in control of resistant symptom in hypothyroid patient’s under thyroid hormone replacement treatment
Public title
The effect of ginger on hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with controlled thyroid dysfunction, who still complains of symptoms Serum TSH level should be between .5 -5 units Informed consent of patients to participate in the study Age range 20-60 years Body mass index 19-35
Exclusion criteria:
Pregnancy 2. Co-infection with other thyroid diseases 3. Any type of malignancy 4. Experience the courage of ginger 5. Liver and kidney failure 6. Diseases related to the hypothalamic pituitary pathway 7. With malabsorption disorders such as celiac disease, IBD, atrophic gastritis 8. Concomitant use of drugs such as phenobarbital, phenytoin, carbamazepine, rifampin, glucocorticoid, estrogen, raloxifene 9- caused by severe mental illness 10- Use warfarin and statins 11. Purpose of pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using a block size 4 block randomization method based on the list provided by Random Allocation software separately for each patient group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo is given to participants in a color and drug-like odor scheme, and none of the dispensing personnel, the laboratory, and the co-worker except the principal therapist know that each patient received the drug or the medication.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of Medical Sciences
Street address
Zand Boulevard, Imam Hussein Square, School of Medicine
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.SUMS.MED.REC.1398.548

Health conditions studied

1

Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism

Primary outcomes

1

Description
Symptoms of refractory symptoms in hypothyroid patients
Timepoint
Baseline and one month after treatment
Method of measurement
ThySRQ questionnaire

Secondary outcomes

1

Description
TSH
Timepoint
At baseline and after one month
Method of measurement
chemiluminescence

2

Description
Fasting blood sugar
Timepoint
At baseline and one month later
Method of measurement
chromatography

3

Description
Lipid Profile
Timepoint
At baseline and one month later
Method of measurement
chromatography

Intervention groups

1

Description
Intervention group: Ginger capsule 500 mg 2 times a day
Category
Treatment - Drugs

2

Description
Control group: Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Mofatteh Clinic
Full name of responsible person
Hamide Ashraf
Street address
10 Golestan Ave; Imam Khomeini Blvd; Shahid Mofteh Clinic
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 3299
Email
tbsonati94@yahoo.com
Web page address
http://www.cmofateh.yums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Zand Street, Next to the Red Crescent, Central Building of Shiraz University of Medical Sciences, Seventh Floor
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Ashraf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Tohid Ave ; Bagherkhan Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984989
Phone
0098 74 3233667
Email
tbsonati94@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Ashraf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Tohid Ave ; Bagherkhan Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984989
Phone
0098 74 3233667
Email
tbsonati94@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamide Ashraf
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 3, Tohid Ave ; Bagherkhan Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984989
Phone
0098 74 3233667
Email
tbsonati94@yahoo.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
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
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