None listed
Conditions
Interventions
Intervention1: 1.Test Oil: Dose:5-8ml, depending on the length of hair.
Frequency:Once Daily
Route of administration: Topical Application
Duration of therapy: 90 days for each subject
Control Interv
Sponsors
Dabur Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjectsâ?? in general good health. 2.Subjects in the age group 18-45 years (both the ages inclusive). 3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit. 4.Subjects with hair fall- above 20 hair fall in comb test (with bulb+ without bulb) 5.Subjects with follicular density above 100-200 6.Subjects complaining of hair fall 7.Subjects complaining about hair thinning 8.Subjects who have not participated in a similar investigation in the past three months. 9.Healthy volunteers with no known allergy as established by medical history. 10.Subjects who do not smoke or drink 11.Subjects who are not crash dieting. 12.Subjects who agree to refrain from using hair dye / hair color during the study period. 13.Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration. 14.Subjects with regular oiling habits
Exclusion criteria
Exclusion criteria: 1.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 2.Subjects who have had hair transplant. 3.Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia 4.Subjects who have undergone hair growth treatment within 3 months before screening into the study. 5.Subjects having any active scalp diseasewhichmayinterfere in the studydermatologistâ??sjudgement. 6.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study. 7.Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania. 8.Subjects consuming alcohol and smoking 9.Subjects on oral medications which will compromise the study. 10.Subjects who are pregnant or lactating or nursing as established with medical history. 11.Under medical treatment for hair problems 12.Undergoing any chemical hair salon treatment- straightening / perming / colour 13.Menopausal female subjects as determined by medical history. 14.Pregnant female subjects as determined by UPT test 15.Chronic illness which may influence the cutaneous state. Subjects participating in other similar cosmetic or therapeutic trial within last three months 16.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant improvement in hair fall reduction, improvement in hair growth, improvement in hair density, hair thinning, thickness and hair strength in comparison to baseline and observational group Equivalence or superiority of efficacy in hair fall reduction improving hair growth, improvement in hair density, thickness and hair strength in comparison to comparator group. Timepoint: Approximately 108 days for each subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant product tolerance in terms of local intolerance and product related AE reported during the studyTimepoint: Approximately 108 days for each subject | — |
Countries
India
Contacts
Public ContactRitambhara
MS Clinical Research Pvt Ltd
Outcome results
None listed