A single arm, exploratory and pilot study to evaluate the efficacy of a multi-component water-based herbal supplement in hair growth, density, follicle strength and hair fall in healthy male and female subjects

2021 ◽  
Vol 7 (3) ◽  
pp. 249-255
Author(s):  
C.S Janaki ◽  
Mukta Sachdev ◽  
Ritambhara
Keyword(s):  
Hair Growth ◽  
Inflammatory Factors ◽  
Herbal Supplement ◽  
Healthy Male ◽  
Open Label ◽  
Entire Study ◽  
Male And Female ◽  
Regular Consumption ◽  
Study Population ◽  
Female Subjects

Most available therapeutics to address alopecia are based on singular targets and mechanism of action based on the assumption of sub-classification to reflect morphological or etiological sub-classes such as hereditary vs acquired factors, anti-inflammatory vs. non-inflammatory factors or scarring vs. non-scarring factors. Impact of oral consumption of Diabliss Hair Water, a multi-component herbal water supplement (HWS) on hair fall reduction, hair growth, hair density, hair thickness was investigated in a single arm, exploratory, pilot open label clinical study among healthy male and female subjects of age group between 35-50 years, with hair fall and hair thinning concerns. The study was conducted under dermatological control and included hair fall by comb test, hair pull test, hair thinning measurement using photo numerical scale (modified Norwood and Ludwig scale) and assessment for hair quality along with the phototrichogram assessment using Trichoscan® with Cutiscope. The Diabliss HWS was efficacious in improving hair growth rate and density as per TrichoScan® assessment, improvement in hair thickness as per Caslite-Nova software. The Diabliss HWS was also efficacious in improving the hair tensile strength (break force by Chatillon Force gauge), reducing hair fall and improving the hair quality. By the end of the study the Diabliss HWS was found to show an improvement in the entire study population in all of the assessments parameters. Dermatologist assessment parameters of hair texture and hair shine also showed improvements in the entire study population. The Diabliss HWS was found to be efficacious in providing hair fall control and hair growth benefits as per the dermatological and instrumental evaluations using TrichoScan®. The product was well tolerated with no product related AE or SAE with regular consumption for 06 months.

scholarly journals Efficacy of an Anthocyanin and Prebiotic Blend on Intestinal Environment in Obese Male and Female Subjects

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Shelly N. Hester ◽  
Angela Mastaloudis ◽  
Russell Gray ◽  
Joseph M. Antony ◽  
Mal Evans ◽  
...  
Keyword(s):  
Intestinal Inflammation ◽  
Inflammatory Marker ◽  
Fecal Calprotectin ◽  
Health And Wellness ◽  
Open Label ◽  
Open Label Study ◽  
Male And Female ◽  
Regular Consumption ◽  
Nonsignificant Decrease ◽  
Obese Male

Background. Anthocyanins and prebiotics impact overall health and wellness, likely through modulation of the microbiota and the intestinal ecosystem. Objectives. An 8-week open-label study in male and female volunteers with uncomplicated obesity was designed to study the efficacy of an anthocyanin and prebiotic blend in modulating intestinal microbiota and intestinal inflammation. Results. After 8 weeks of daily supplementation, participants had a significant decrease in Firmicutes (p<0.001) and Actinobacteria (p<0.001) and a significant increase in Bacteroidetes (p<0.001). Bowel habits were improved as evidenced by reductions in the severity of bloating (p<0.05), gas (p=0.035), and abdominal pain (p=0.015) as well as significant improvements in stool consistency (p<0.05). Finally, a nonsignificant decrease in the inflammatory marker fecal calprotectin was seen (p=0.107). The supplement was safe and well tolerated. Conclusions. The results suggest that regular consumption of the anthocyanin-prebiotic blend positively modulated the intestinal ecosystem and provided insights into the mechanisms of action and its impact on health benefits.

Ipragliflozin Does Not Prolong QTc Interval in Healthy Male and Female Subjects: A Phase I Study

2013 ◽  
Vol 35 (8) ◽  
pp. 1150-1161.e3 ◽  
Author(s):  
Wenhui Zhang ◽  
Ronald Smulders ◽  
Anura Abeyratne ◽  
Albert Dietz ◽  
Walter Krauwinkel ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Qtc Interval ◽  
Healthy Male ◽  
Male And Female ◽  
Female Subjects

A phase I study to evaluate the pharmacokinetics of a new oncology nce, apatinib mesylate tablets, with and without food following single and multiple doses in healthy subjects.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14049-e14049 ◽  
Author(s):  
Luana Pesco Koplowitz ◽  
Barry Koplowitz ◽  
Cheol Hee Park ◽  
Arlo N. McGinn
Keyword(s):  
Food Effect ◽  
Dose Proportionality ◽  
Metabolic Effects ◽  
Open Label ◽  
Male And Female ◽  
Study Section ◽  
Delayed Initiation ◽  
Dosing Regimens ◽  
Intermediate Metabolizers ◽  
Female Subjects

e14049 Background: Apatinib Mesylate (YN968D1) is a selective inhibitor of VEGFR-2 being developed for the treatment of advanced gastric cancer. Objectives: 1. Evaluate single- and multiple-dose PKs 2. Evaluate food effect on bioavailability 3. Evaluate dose-proportionality 4. Determine CYP3A4 and 2C19 metabolic effects on the PKs Methods: Single ascending-dose (SAD), open-label, crossover of 2 oral doses of apatinib mesylate tablets (100 mg and 250 mg, [81 mg and 201 mg apatinib]) in healthy male and female volunteers with a minimum 3-day washout between dosing, plus a multiple ascending-dose (MAD), open-label, crossover study of the same doses. Both doses were administered with and without food in a crossover for the SAD and MAD parts. PK blood samples were collected for each dosing period. Subjects were genotyped for CYP3A4 and CYP2C19. WinNonlin 6.4 used for analysis. Results: 24 male and female subjects completed the SAD study section. They were extensive or intermediate metabolizers of CYP2C19, and 23/24 were normal metabolizers of CYP3A4. 22 male and female subjects completed the MAD study section. Most were extensive, intermediate or ultra-rapid metabolizers of CYP2C19; 21/22 subjects were normal metabolizers of CYP3A4. Conclusions: For the 100 mg dose in the SAD and MAD parts of the study, there was no significant food effect. For the 250 mg dose in SAD and MAD parts, food appeared to increase bioavailability by 20–30% in the SAD part, and 30–40% in the MAD part. Noncompartmental PK analysis of the SAD and MAD showed medium tmaxvalue delayed at 2 doses when apatinib was administered with food. Compartmental PK analysis showed food delayed initiation in absorption and reduced first order absorption rate constant. Dose proportionality was confirmed only for the AUC0-∞ value from the SAD-fasted cohort but inconclusive for Cmax and AUC parameters under other dosing regimens. Visual inspection of the effect of CYP2C19 genotype on the clearance of apatinib did not show correlation. Inspection of CYP3A4 genotype on the calculated clearance values was tenuous given the intermediate metabolizers (N = 1), compared to extensive metabolizers.

The Gender Effects of Heart Rate Variability Response during Short-Term Exercise using Stair Stepper from Statistical Analysis

2016 ◽  
Vol 2 (2) ◽  
pp. 359 ◽  
Author(s):  
Nor Aziyatul Izni Mohd Rosli ◽  
Mohd Azizi Abdul Rahman ◽  
Malarvili Balakrishnan ◽  
Takashi Komeda ◽  
Saiful Amri Mazlan ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Nervous System ◽  
Gender Effects ◽  
P Value ◽  
Healthy Male ◽  
Short Term ◽  
Male And Female ◽  
Males And Females ◽  
Female Subjects

This study is aimed to explore the Heart Rate Variability (HRV) response during short-term exercise by stair stepper and to compare the finding between young healthy male and female subjects. The responses were statistically analyzed by applying independent-samples t-test statistical method. The calculation of Coefficient of Variation (CoV (%)) and the slope of the linear regression is used to assess the steadiness of the HRV. Furthermore, the results also demonstrated that female subjects had greater significant p-value of RMSSD feature and significance p-value in a LF feature is greater in male. Thus, the ongoing results demonstrated that males have the sympathetic drive and females have predominant parasympathetic drive using short-term exercise by stepper. Thus, the experiment results indicate the suitability of developing rehabilitation devices in the field of Autonomic Nervous System (ANS), research, control system and rehabilitation enginering, which may help to isolate males and females.

scholarly journals A Study of Antithrombin III Levels in Healthy Male and Female Subjects Tested Monthly for Eleven Months by Four Methods

1977 ◽  
Author(s):  
M.S. Sirridge ◽  
R. Shannon
Keyword(s):  
Standard Deviation ◽  
Functional Activity ◽  
Antithrombin Iii ◽  
Normal Subjects ◽  
Healthy Male ◽  
Male And Female ◽  
Serum Pool ◽  
Coefficients Of Variation ◽  
Activity Method ◽  
Female Subjects

Because of the increased interest in the role of Antithrombin III as a physiologic coagulation inhibitor and because of some previous problems we encountered in sequential measurement of this protein, the present study was designed to answer 3 questions: 1) Which of four methods (2 functional activity methods and 2 immunologic methods) is the most practical, accurate and reproducible? 2) Do normal subjects have relatively constant levels when tested sequentially by these methods? 3) What is the range of Antithrombin III levels in young healthy male and female subjects? A serum pool was tested by each of the 3 serum methods at least 20 different times throughout the study. The von Kaulla functional activity method gave the lowest standard deviation and coefficient of variation. In the group of 29 subjects this method proved to be the most practical and also gave very low coefficients of variation for individual subjects when they were tested from 11 to 16 times (range .023-.054). The other methods did not give such low coefficients of variation for individual subjects. The range of levels was 77 to 110% on 344 samples tested by the von Kaulla method With a mean of 92.8% and a standard deviation of 6.4%. The standard deviations for the pool and for individual subjects were greater but quite satisfactory for all methods.

scholarly journals Innervation Zones of the External Anal Sphincter in Healthy Male and Female Subjects

Digestion ◽  
2004 ◽  
Vol 69 (2) ◽  
pp. 123-130 ◽  
Author(s):  
P. Enck ◽  
H. Franz ◽  
F. Azpiroz ◽  
X. Fernandez-Fraga ◽  
H. Hinninghofen ◽  
...  
Keyword(s):  
Anal Sphincter ◽  
External Anal Sphincter ◽  
Healthy Male ◽  
Male And Female ◽  
Female Subjects
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