To determine and evaluate the percentage of hair fall reduction after 2% Minoxidil usage, after Anagen Grow usage, after combination therapy (2% Minoxidil plus Anagen Grow) over 12 weeks period.
- Conditions
- Health Condition 1: L659- Nonscarring hair loss, unspecified
- Registration Number
- CTRI/2022/02/040499
- Lead Sponsor
- Dr JRKs Research and Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1.Healthy male or female subjects
2.Subjects in the age group 22-40 years (both the ages inclusive).
3.Subjects willing to give written informed consent and agree to come for regular follow up visits.
4.Subjects willing to maintain the same hairstyle by abstaining from coloring, experimenting with newer shampoos and other types of hair care products during the study period.
5.Subjects willing to refrain from perming and straightening during the study period.
6.Subjects who are willing to avoid usage of oral medications for hair growth during the study period.
7.Subjects whose laboratory values during screening period are within normal limits or considered normal by the physician or Principal/Clinical Investigator and have no clinical significance.
8.Subjects who have no clinically significant abnormalities on the scalp during physical examination such as Tinea capitis, dandruff, Seborrheic dermatitis, Piedra, head louse and scabies.
9.Subjects with no clinical abnormalities during physical examination, which may interfere in the trial.
10.Female subjects with negative urine pregnancy test.
11.Female subjects willing to avoid conception of pregnancy during study period
1.Subjects with known hypersensitivity to minoxidil and allergic skin.
2.Pregnant or lactating females.
3.Subjects with history of hypotension (blood pressure less than 90/60 mmHg).
4.Subjects with untreated or uncontrolled hypertension.
5.Subjects with chronic dermatological conditions of the scalp (e.g., eczema, psoriasis, infection etc).
6.Subjects with inflammatory scalp conditions such as lichen planopilaris.
7.Subjects with current or prior use of oral hair regrowth medications (finasteride, other 5 alpha reductase inhibitors) within one year or the use of nutraceutical/botanical for the above purpose in last three months before enrolment.
8.Subjects with application of a topical minoxidil preparation, or any other topical over the counter or prescription medication for hair regrowth to the scalp for two weeks or more during the six months before enrolment.
9.Subjects using medications known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics.
10.Subjects with concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, cytostatics, etc,)
11.Subjects with prior hair transplant or hair weaves.
12.Subjects with serious androgenic alopecia.
13.Subjects with folliculitis.
14.Subjects with presence or history of cancer including skin cancer.
15.Subjects with presence or history of an immunocompromised disease.
16.Subjects known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
17.Subjects with history of severe cardiac, pulmonary, hepatic, renal, endocrine, neurologic disease or mental illness.
18.Subjects with any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation.
19.Subjects who have participated in a clinical study in the past 30 days or current participation in another clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the percentage hair fall reduction after 2% Minoxidil usage over 12 weeks period. <br/ ><br>To determine the percentage hair fall reduction after Anagen Grow usage over 12 weeks period. <br/ ><br>To determine the percentage hair fall reduction after usage of combination therapy (2% Minoxidil plus Anagen Grow) over 12 weeks periodTimepoint: Hair loss measured at Time points: Baseline, Week 4, 8 and 12 <br/ ><br>Proportion of anagen hair measured at time points: Baseline and Week 12
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Anagen Grow and combination therapy <br/ ><br>To study the overall organoleptic aspects of the above three lines of therapy. <br/ ><br>To access the concordance between the volunteers experience vis-� -vis clinical outcome <br/ ><br>Timepoint: 12 weeks