Health Condition 1: L659- Nonscarring hair loss, unspecified
Conditions
Interventions
Intervention1: SESA AYURVEDIC OIL WITH 18 HERBS: Mode of Usage: The test treatment will be applied topically to the scalp using approximately 5-10 mL, ensuring even distribution by parting the hair. I
Sponsors
Sesa Care Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 45 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant or non-lactating females (preferably equal number of males and females). 3) Females of childbearing potential must have a self-reported negative urine pregnancy. 4) Participant is in good general health as determined by the Investigator on the basis of medical history. 5) Participants with alopecia characterized by daily hair shedding greater than 100 and less than or equal to 150 strands/day, confirmed at screening through investigator assessment using the standardized 60-second combing test and participant feedback. (set maximum limit of shedding per day as well to establish grade capping of alopecia) 6) Participants who are on contraceptive or hormonal therapy must be able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 7) If the participant is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 8) Participants are willing to give written informed consent and are willing to follow the study procedure. 9) Participants who commit not to use any other medicated or prescription shampoos or hair care treatments (containing Minoxidil), any other hair growth treatments or hair colour or dye, other than the test treatments for the entire duration of the study. 10) Willing to use test treatments throughout the study period. 11) Participant is willing and able to follow and allow study staff to performed study test methods. 12) Participant is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 13) Participant must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Participant have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems. 2) Participant have history of any dermatological condition of the scalp other than hair loss and dandruff. 3) Participant have history of any prior hair growth procedures done (e.g. hair transplant or laser). 4) Participant who had taken topical treatment of hair loss for at least 4 weeks before enrolment. 5) Participant who had taken any systemic treatment for any illnesses for at least 3 months. 6) History of alcohol or drug addiction. 7) Participant having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease. 8) Participant having history or present condition of an allergic response to any cosmetic treatments, any other condition which could warrant exclusion from the study. 9) Pregnant or breast feeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state. 11) Participant have participated any clinical research study related to hair care treatments. 12) Participant have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months. 13) Participant is currently undergoing prescription based treatment involving consumption of medicines and/or non-prescription based self-induced health supplement treatment of any kind.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test treatment in terms of change in number of new hair strands count evaluated by Image pro-analysis 2.To evaluate the effectiveness of the test treatment in terms of change in hair growth rate evaluated through CASLite Nova 3.To evaluate the effectiveness of the test treatment in terms of change in anagen and telogen ratio evaluated through Trichogram and using the pluck test performed by a Dermatologist-trained evaluator or Dermatologist 4.To evaluate the effectiveness of the test treatment in terms of change in hair fall (from scalp root & due to hair breakage) evaluated through 60-second hair combing test performed by a Dermatologist-trained evaluator or DermatologistTimepoint: 1. Baseline on Day 01, Day 30, Day 45 and Day 90. 2. Day -04, Baseline on Day 01, Day 27, Day 30, Day 87 and Day 90. 3. Baseline on Day 01, Day 30, Day 45 and Day 90. 4. Baseline on Day 01, Day 30, Day 45 and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test treatment in terms of change in hair thickness, hair density evaluated through CASLite NovaTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in hair shaft diameter evaluated through magnus microscopeTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair dryness, hair strength evaluated by a Dermatologist-trained evaluator or DermatologistTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in general appearance of scalp i.e. Itchiness, redness, roughness, scaliness and dryness evaluated by a Dermatologist-trained evaluator or DermatologistTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in tensile strength of hair evaluated by TESTRONIX tensile tester of hairTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in hair strength evaluated by a Dermatologist-trained evaluator or Dermatologist by hair pull testTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in follicular miniaturization evaluated through CASLite NovaTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;To evaluate the effectiveness of the test treatment in terms of change in participant perception questionnaire using 5- point Likert scaleTimepoint: Baseline on Day 01, Day 30, Day 45 and Day 90.;Safety will be determined by treatment emergent adverse events such as irritation, redness, scaliness, roughness, erythema, itching from baseline before usage and after usage of the Test treatmen | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed