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Trial registered on ANZCTR
Registration number
ACTRN12618001262291
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
26/07/2018
Date last updated
27/02/2023
Date data sharing statement initially provided
1/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy of a herbal extract, orally-dosed or topically applied on increasing hair growth and decreasing hair loss in males and females.
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Scientific title
Efficacy of Ageratum conyzoides, orally-dosed or topically applied on increasing hair growth and decreasing hair loss in males and females. A randomised double-blind placebo-controlled study.
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Secondary ID [1]
294827
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nil known
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Universal Trial Number (UTN)
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Trial acronym
AGC-HRG18
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Balding
307765
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Condition category
Condition code
Alternative and Complementary Medicine
306811
306811
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0
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Herbal remedies
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Skin
307795
307795
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Product 1: Ageratum conyzoides topical gel 0.5% strength - 2 teaspoon rubbed directly onto the scalp morning and evening.
Product 2: Topical gel placebo - 2 teaspoon rubbed directly onto the scalp morning and evening.
Product 3: Ageratum conyzoides 250 mg capsule taken orally once daily with 250 mL water at breakfast.
Product 4: Placebo capsule - taken orally once daily with 250 mL water at breakfast.
All 4 products are to be used over a 12 week period.
Adherence will be monitored with trial product container return at the end of the study.
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Intervention code [1]
301139
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Treatment: Other
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Comparator / control treatment
Topical gel placebo comprised of water and xanthan gum
Placebo capsule comprised of microcrystalline cellulose andmaltodextrin
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Control group
Placebo
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Outcomes
Primary outcome [1]
305804
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Change in hair growth (hair density and breakage) - Using the HairCheck instrument (an automated digital tool which measures hair density and breakage)
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Assessment method [1]
305804
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Timepoint [1]
305804
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Baseline, weeks, 4, 8 and 12 (primary endpoint) post commencement of intervention
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Secondary outcome [1]
346601
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Hair strength measured using densitometry
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Assessment method [1]
346601
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Timepoint [1]
346601
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [2]
346602
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hair loss measured using hair comb test
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Assessment method [2]
346602
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Timepoint [2]
346602
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Baseline, weeks, 4 8 and 12 post commencement of intervention
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Secondary outcome [3]
346603
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change in hair colour assessed using photographs
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Assessment method [3]
346603
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Timepoint [3]
346603
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Baseline, weeks, 4, 8 and 12 post commencement of intervention
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Secondary outcome [4]
346607
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Full blood count measured via blood test
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Assessment method [4]
346607
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Timepoint [4]
346607
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Baseline and week 12 post commencement of intervention
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Secondary outcome [5]
346608
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ferritin measured via blood test
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Assessment method [5]
346608
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Timepoint [5]
346608
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Baseline and week 12 post commencement of intervention
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Secondary outcome [6]
346609
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Thyroid stimulating hormone measured via blood test
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Assessment method [6]
346609
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Timepoint [6]
346609
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Baseline and week 12 post commencement of intervention
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Secondary outcome [7]
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Vitamin D measured via blood test
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Assessment method [7]
346610
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Timepoint [7]
346610
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Baseline and week 12 post commencement of intervention
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Secondary outcome [8]
346611
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Testosterone measured via blood test
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Assessment method [8]
346611
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Timepoint [8]
346611
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Baseline and week 12 post commencement of intervention
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Secondary outcome [9]
346612
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IGF-1 measured via blood test
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Assessment method [9]
346612
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Timepoint [9]
346612
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Baseline and week 12 post commencement of intervention
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Secondary outcome [10]
346613
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HDL measured via blood test
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Assessment method [10]
346613
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Timepoint [10]
346613
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Baseline and week 12 post commencement of intervention
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Secondary outcome [11]
346614
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Erdr1 measured via blood test
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Assessment method [11]
346614
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Timepoint [11]
346614
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Baseline and week 12 post commencement of intervention
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Secondary outcome [12]
346615
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PTGDS measured via blood test
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Assessment method [12]
346615
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Timepoint [12]
346615
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Baseline and week 12 post commencement of intervention
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Secondary outcome [13]
346616
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GPR44 measured via blood test
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Assessment method [13]
346616
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Timepoint [13]
346616
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Baseline and week 12 post commencement of intervention
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Secondary outcome [14]
346617
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Subjective improvement measured via questionnaires designed for this study
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Assessment method [14]
346617
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Timepoint [14]
346617
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [15]
349616
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hair strength measured using Norwood/Hamilton and Ludwig/Salvin scale
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Assessment method [15]
349616
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Timepoint [15]
349616
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [16]
349618
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hair strength measured using scalp photographs
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Assessment method [16]
349618
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Timepoint [16]
349618
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [17]
349619
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hair loss measured using scalp photographs
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Assessment method [17]
349619
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Timepoint [17]
349619
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Baseline, weeks, 4, 8 and 12 post commencement of intervention
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Secondary outcome [18]
349620
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hair loss measured using tug/pull test
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Assessment method [18]
349620
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Timepoint [18]
349620
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Baseline, weeks, 4 8 and 12 post commencement of intervention
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Secondary outcome [19]
349902
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Hair thickness measured using densitometry - Density and thickness are different measures - this is meant to be thickness.
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Assessment method [19]
349902
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Timepoint [19]
349902
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [20]
349903
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hair thickness measured using Norwood/Hamilton and Ludwig/Salvin scale
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Assessment method [20]
349903
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Timepoint [20]
349903
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [21]
349905
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hair thickness measured using scalp photographs
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Assessment method [21]
349905
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Timepoint [21]
349905
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Baseline, weeks 4, 8 and 12 post commencement of intervention
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Secondary outcome [22]
397204
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PGDT measured via blood tests
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Assessment method [22]
397204
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Timepoint [22]
397204
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Baseline and Week 12 post commencement of intervention
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Eligibility
Key inclusion criteria
Males and females over 18 years of age reporting hair loss
Participants who agree to maintain a consistent dietary habit throughout the study
Participants who agree to maintain consistent shampoo frequency
Participants who agree to not use other treatment for baldness during the study
Participants agreement to participation in the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled
- Scalp conditions or any other genetic disease or issue that could contribute to baldness
- Current use of hair growth formulations and/or use in the past 3 months
- Participants who have taken Radiotherapy to scalp for cancer treatment
- Participants with a current or past history of Cicatricial alopecia
- Women with clinical diagnosis of: Menstrual and/or endocrine disorders, PCOS, Hyper-androgenism.
- Previously used or continue to use ani-hypertensives, steroids, spironolactone, ketokonazole, cytotoxic compounds, anticonvulsant drugs, testosterone or testosterone boosting supplements, oestrogens or progesterone within the last six months
- Reported participation in another hair growth trial 3 months before the start of the study
- Alterations in hair style
- Extreme hair types (eg dreadlocks, afro) and also anyone who has had considerable colouring, bleaching, straightening or curling
- Females not on a suitable form of birth control
- Pregnant, up to 12 months post-partum or lactating
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A total of 33 participants are required to have a 90% chance of detecting a significant change (at the 5% level), in hair density from baseline in the experimental group of 2 mm/cm3. 40 participants per group will be recruited to allow for withdrawals.
Statistical tests will be used to compare differences between groups for hair growth (density, strength and thickness), loss and colour as well as blood markers and questionnaire results. The change in hair density and hair loss will be measured as a within group mean difference change from baseline over the 12 weeks of treatment as well as a comparison between the groups. Statistical analysis will be conducted based on the normality of the data and mean and variance statistical significance (p<0.05) will be calculated using ANOVA and t-tests or Mann-Whitney test if appropriate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/09/2020
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Actual
28/09/2020
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Date of last participant enrolment
Anticipated
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Actual
17/12/2021
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Date of last data collection
Anticipated
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Actual
18/03/2022
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Sample size
Target
160
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Accrual to date
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Final
165
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
299422
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Commercial sector/Industry
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Name [1]
299422
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Gencor Pacific
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Address [1]
299422
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21-E,Elegance Hillgrove Village, Discovery Bay, Hong Kong
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Country [1]
299422
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Hong Kong
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Primary sponsor type
Commercial sector/Industry
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Name
RDC Global Pty Ltd
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Address
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
Australia
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Secondary sponsor category [1]
298708
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Commercial sector/Industry
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Name [1]
298708
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Pharmako Biotechnologies Pty Ltd
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Address [1]
298708
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Campbell Ave Cromer
NSW 2099 AUS
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Country [1]
298708
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300322
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [1]
300322
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St Lucia QLD 4072
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Ethics committee country [1]
300322
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Australia
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Date submitted for ethics approval [1]
300322
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31/07/2018
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Approval date [1]
300322
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13/02/2019
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Ethics approval number [1]
300322
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Summary
Brief summary
Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either one of 2 placebo comparator groups or one of two investigational intervention groups. Prior to treatment, participants will undertake various hair assessments including photographs of scalp (unidentifiable), hair comb/count test, hair tug/pull test, densitometry (haircheck®) and also undertake a blood test. Participants will be asked to consume or apply the allocated product according to the dose prescribed and attend the clinic every month for a repeat of baseline measures excluding the blood test. At week 12 participants will be asked to attend the clinic for a final assessment including all measures undertaken at baseline, a final blood test and an exit interview.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
83294
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Dr David Briskey
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Address
83294
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RDC Global Pty Ltd
3B/76 Doggett St
Newstead, QLD, 4006
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Country
83294
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Australia
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Phone
83294
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+61 421 784 077
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Fax
83294
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Email
83294
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[email protected]
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Contact person for public queries
Name
83295
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Amanda Rao
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Address
83295
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RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
83295
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Australia
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Phone
83295
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+61 414 488 559
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Fax
83295
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Email
83295
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[email protected]
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Contact person for scientific queries
Name
83296
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Amanda Rao
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Address
83296
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RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
83296
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Australia
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Phone
83296
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+61 414 488 559
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Fax
83296
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Email
83296
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5527
Ethical approval
375059-(Uploaded-23-10-2019-12-59-25)-Study-related document.pdf
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.
Download to PDF