Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001277730
Ethics application status
Not yet submitted
Date submitted
15/11/2013
Date registered
19/11/2013
Date last updated
19/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral L-tyrosin for reversing gray hair; a clinical trial
Scientific title
The effect of supplementary oral L-tyrosin plus other essential elements (Dr Daniel capsule for gray hair) on reversing gray hair
Secondary ID [1] 283600 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gray hair 290523 0
Condition category
Condition code
Alternative and Complementary Medicine 290912 290912 0 0
Other alternative and complementary medicine
Skin 290913 290913 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups of normal men with gray hair (total=15) will receive daily oral L-tyrosin 500 mg or 3000 mg daily plus other essential elements including 50 mg (in cases on 500 mg L-tyrosin) or 300 mg (in cases on 3000 mg L-tyrosin) 5-hydroxytriptophan (5-HTP) and 500 mg cysteine (Dr Daniel capsule for gray hair) in the intervention groups; or oral placebo (glucose) in the control group for 6 consecutive months.
Diet will be similar during the study period in all three groups.
Adherence interventions will include monthly instruction in forms of oral and written material.
Adherence to taking medication will be monitored by drug capsule return monthly.
Intervention code [1] 288289 0
Treatment: Drugs
Comparator / control treatment
Patients in the control group will receive oral placebo (capsules identical to those with medication in the intervention groups, containing only glucose) once daily for 6 consecutive months.
Control group
Placebo

Outcomes
Primary outcome [1] 290901 0
Number of gray hairs on the frontal, parietal, temporal and occipital regions on both sides, separately.
For this purpose, the participants will wear a specially designed yarn hat with holes (10 cm in diameter) on each region of the skull on both sides. An examiner will count gray hairs in each hole separately under direct light and magnification.
Timepoint [1] 290901 0
baseline, month 3, month 6, month 9.
Secondary outcome [1] 305569 0
Possible complications of L-tyrosine plus 5-HTP such as problems in appetite, sleep, sexual behavior, temperature and pain sensation, nausea, fatigue, headaches, heartburn, joint pain, mood changes, irritability and changes in heart rate by asking from patients.
Timepoint [1] 305569 0
During the study period.

Eligibility
Key inclusion criteria
Normal men with gray hair.
Minimum age
30 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Secondary gray hair, malnutrition, taking other medications/supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Repeated measures analysis.
Due to lack of previous similar study, the investigators decided to conduct it as a pilot study on 5 cases in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 5628 0
Iran, Islamic Republic Of
State/province [1] 5628 0
East Azerbaijan

Funding & Sponsors
Funding source category [1] 288281 0
University
Name [1] 288281 0
Tabriz University of Medical Sciences, Drug Applied Research Center
Country [1] 288281 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Daniel F Fouladi
Address
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286999 0
None
Name [1] 286999 0
Address [1] 286999 0
Country [1] 286999 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290176 0
Tabriz University of Medical Sciences
Ethics committee address [1] 290176 0
Ethics committee country [1] 290176 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 290176 0
15/12/2013
Approval date [1] 290176 0
Ethics approval number [1] 290176 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44362 0
Dr Daniel F Fouladi
Address 44362 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44362 0
Iran, Islamic Republic Of
Phone 44362 0
+989144122542
Fax 44362 0
Email 44362 0
[email protected]
Contact person for public queries
Name 44363 0
Daniel F Fouladi
Address 44363 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44363 0
Iran, Islamic Republic Of
Phone 44363 0
+989144122542
Fax 44363 0
Email 44363 0
[email protected]
Contact person for scientific queries
Name 44364 0
Daniel F Fouladi
Address 44364 0
Drug Applied Research Center, Tabriz University of Medical Sciences, Pashmineh Building, Daneshgah St., Tabriz-Iran. Post Code: 51656-65811.
Country 44364 0
Iran, Islamic Republic Of
Phone 44364 0
+989144122542
Fax 44364 0
Email 44364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.