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
|
|
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
|
|
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. |