None listed
Conditions
Interventions
Intervention1: Vispo: Oral administration of single dose of Vispo 400mg capsule everyday for 112 days
Intervention2: Vispo: 5ml lotion once a day for 112 days
Control Intervention1: Placebo: Oral admi
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: l Healthy subjects, as determined by the investigator. 3. Presence of androgenetic alopecia In male: Norwood Hamilton Scale grade II to VA with vertex involvement. In females: Sinclair scale for female pattern hair loss: Grade II to IV. 4. Agrees not to use products with the same end benefit during the entire study period. 5. Willingness to be photographed and provide consent for photographic release. 6. Subjects who agree to refrain from using hair dye / hair colour/ hair treatment (like perming, straightening etc.) during the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects having conditions like alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa. 2. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving. 3. Subjects with history of any chronic health conditions, Endocrine abnormalities, Pychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Bariatric surgery/ eating disorder such as bulimia or binge eating. History of any other major surgery 4. Use of the following during the 6 months prior to screening: Minoxidil (oral or topical) Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketocnazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months. Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens), Anabolic steroids, Lithium and phenothiazines. Use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the study. Use of isotretinoin, light therapy, radiation to the scalp, or chemotherapy within the past year. 5. Subjects allergic to herbal products or any component of the study product 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 7. Subjects who have had hair transplant. 8. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 9. Menopausal female subjects as determined by medical history 10.Known HIV or Hepatitis B positive or any other immuno-compromised state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hair fallTimepoint: Day 1, Day 56 and Day 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BiomarkersTimepoint: Day 1,Day 112;Mean change in Hair density and Questionnaire based assessmentsTimepoint: Day 1, Day 56 and Day 112;Over all SafetyTimepoint: Day 1, Day 56 and Day 112 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bioservices Pvt. Ltd
Outcome results
None listed