None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed