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CTRI Number  CTRI/2020/10/028698 [Registered on: 28/10/2020] Trial Registered Prospectively
Last Modified On: 15/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Clinical trial of Nutraceutical product Power Gummies : hair and nail vitamin. 
Scientific Title of Study   A parallel arm clinical trial to evaluate safety and efficacy of Power Gummies : hair and nail vitamin; in hair fall reduction, accelerated hair growth, strengthening of hair with overall hair and scalp health improvement in healthy female and male. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/20-21/004 Version 1.0 dated, 21st July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umesh Gajare  
Designation  Consultant  
Affiliation  Jyoti Clinic and Research Centre  
Address  OPD 1, Ground floor, B-3 Saipritam , kaliwadi- Rahatni link Road, Kalewadi, Pune-17 Pune MAHARASHTRA 411017 India

Pune
MAHARASHTRA
411017
India 
Phone  8796739140  
Fax    
Email  dr.gajareumesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu  
Designation  Managing Director  
Affiliation  Mprex Healthcare Pvt. Ltd.  
Address  501, Crossroads, Wakad, Pune Pune MAHARASHTRA 411057 India

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax    
Email  gayatri.mbgindia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Kapil Mittal  
Designation  Chief Strategic Officer  
Affiliation  Aesthetic Nutrition Pvt. Ltd.  
Address  M 31 , M Block Market, Greater Kailash 2, New Delhi

South
DELHI
1100048
India 
Phone  9910666670  
Fax    
Email  cso@powergummies.com  
 
Source of Monetary or Material Support  
Aesthetic Nutrition Pvt. Ltd. 
 
Primary Sponsor  
Name  Aesthetic Nutrition Pvt Ltd  
Address  M 31 , M Block Market, Greater Kailash 2, New Delhi- 1100048 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarita Tippannawar  Renaissance Derma Clinic  Office No. 504, Crossroads, Opposite Hotel Ginger, Bhumkar Chowk, Wakad Pune-411057 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9370665436

saritatippannawar17@gmail.com 
Dr Umesh Gajare  Skinovate Laser & Cosmetic Surgery Center LLP  Office Number 302 & 303, 3rd Floor, Royal Avenue Landmark: Next to Hotel Shivar Garden, Pimple Saudagar, Pune Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9422420986

dr.gajareumesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Lokmanya Medical Research Centre  Approved 
Royal Pune Independent Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Scalp, hair and nail health. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Power Gummies: Hair and Nail Vitamin  1 Power Gummy per day for 90 days after each meal.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Male and Female subjects in general good health, subjects in the age group 18-40 years, subjects willing to to give written informed consent and agree to come for a regular follow up visit, subjects not participated in a similar investigations in the past two weeks, subjects complaining of hair fall and damage, subjects who are not on crash dieting, subjects who agree to not to change the brand of currently used hair color, dye, treatment etc., if during the study term, subjects willing to refrain from any type of hair treatment like head massage, oil application, perming, etc. during the study duration, subjects with at least of two of following complaints- dry damaged hair, brittle and thin hair, premature greying of hair, scalp related complaints like itching, dandruff or irritation 
 
ExclusionCriteria 
Details  Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
Subjects having any active scalp disease which may interfere in the study.
Subjects on treatment for active acne
Subjects with history or active phase of malignancy and chemotherapy therefore.
Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
Subjects who have had hair transplant.
Subjects who take pharmaceutical product which cause hirsutism.
Subjects on oral hair growth medications which will compromise the study.
Subjects who are pregnant lactating or nursing as established with medical history.
Chronic illness which may influence the study.
Subjects participating in other similar cosmetic or therapeutic trial within last two weeks
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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the number of terminal hairs and vellus hairs in the target area of the scalp from baseline to end of study identified by Phototrichograms.
Reduction change in the shedding range of the hair in the “60 Second Hair Comb test” from baseline to end of the study. (Hair strength)
Change in folliscopic measurement of hair density and hair diameter (Hair Density), Change in nail growth and satisfaction scale on nail health
 		 Baseline, day 30, day 60 and day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the Hair Assessment Questionnaire, Improvement in the Modified hair wash test (Brittleness and hair loss after washing), Improvement in quality of hair, VAS- Visual analog scale scalp related complaints like itching, dandruff or irritation (Scalp health),Premature graying, Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period, Assessment of Global evaluation of overall improvement in scalp and hair.

 		 Baseline, day 30, day 60 and day 90 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   31/10/2020 
Date of Study Completion (India) 01/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The results of this study showed that the administration of Power Gummies: hair and nail vitamin was safe and effective in hair fall reduction, accelerated hair growth, strengthening of hair with overall hair and scalp health improvement in healthy females and males in 90 days.

The results showed a sig­nificant increase in the hair density, number of the terminal, vellus hair counts at 90 days in a gradual way.

There was an increase in terminal hair count from baseline to day 90. There was an increase in vellus hair count, it is possible that vellus hair get converted in terminal hair to improve the hair density.

The beneficial effects of Power Gummies were observed in both male and female hence it’s an efficacious product for both genders.

Power Gummies presented excellent compliance and tolerability with no adverse events related to its long term consumption.

These measurements were accompanied by significant and progres­sive visible clinical improvement in hair growth and hair quality for the treatment group, as determined by the investi­gator.

These outcomes demonstrated a steady improvement from baseline to day 90, suggesting that improve­ment may progress with continued treatment. There was also a strong trend in reducing hair breakage and improving hair density as well as hair diameter hence making hairs stronger and may improve hair length as well.

The hair with the consumption of Power Gummies was less brittle and strong from roots that there was decreased hair fall in the hair comb and wash test. It is suggestive of the improved strength of the hair.

There was satisfactory around 10% in female and 5% in male the enhanced growth rate of nails.

It was observed from the study that there was improved satisfaction through augmented stronger and longer nails in subjects.

 
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