those rated as no improvement (no change to greatly worsened) for each question. Among those randomized to active treatment, 21 (80.8%) reported significant improvement in thickness of hair body compared with 6 (46.2%) of placebo-treated subjects (x2=4.88, df=1. P equals .027). Furthermore, among those randomized to active treatment, a significant number of subjects improved in overall hair growth, overall hair volume, hair color, amount of noticeable new hair, hair growth rate, stress levels, anxiety levels, sleep quality, overall well-being, skin smoothness, and overall skin health (all P less than .05). Percentage improvement in the active group is summarized in Table 4.
Subject Ease of Use Questionnaire
At the end of study, 84.6% of the active subjects found it easy to add the capsules to their daily routine and found it more convenient to take capsules vs using a topical application. 88.5% preferred taking a natural supplement. 73.1% would recommend it to their friends suffering from hair loss.
Women’s Hair Loss Quality of Life Questionnaire
There were no significant differences between the 2 groups for the total score. In order to examine the improvement, the percentage of subjects who rated themselves as improved (a lot to very much) and those who rated no improvement (not at all to a little) was computed for each item. At the end of the study (day 180) there were significant improvements compared with baseline for the active group subjects on 5 out of 15 items, including how the condition impacts self-esteem, self-consciousness, and feelings of unattractiveness. There were strong trends for 3 more items. None of these changes were significant for the placebo group. These results are summarized in Table 5.
No treatment-related AEs were reported during the study.