Back to resultsthe Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
Primary Purpose
Thyroid Diseases
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
chinese herbs-I
chinese herbs-II
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Diseases
Eligibility Criteria
Inclusion Criteria:
- patient with thyroid diseases
Exclusion Criteria:
- not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high Iodine intake
low Iodine intake
Arm Description
Outcomes
Primary Outcome Measures
diameter，number of the tumor
Secondary Outcome Measures
Full Information
NCT ID
NCT01873014
First Posted
March 7, 2013
Last Updated
February 14, 2016
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01873014
Brief Title
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
Official Title
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine
Detailed Description
Based on the previous studies, the research choose the patients with different iodine intake,and improve our original Chinese Herbs thyroid III formula, in order to provide the patients the best individual treatment plan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high Iodine intake
Arm Type
Experimental
Arm Title
low Iodine intake
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
chinese herbs-I
Intervention Description
two agent per day, twice a day
Intervention Type
Drug
Intervention Name(s)
chinese herbs-II
Intervention Description
two agent per day, twice a day
Primary Outcome Measure Information:
Title
diameter，number of the tumor
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient with thyroid diseases
Exclusion Criteria:
not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yu yang, doctor
Organizational Affiliation
doctor
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake
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