FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044809 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 04/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A study of Chewable Gummies for Hair-fall. 
Scientific Title of Study   An Open Label, Single-Arm, Clinical Study to Evaluate Efficacy and Safety of Chewable Gummies in healthy adult subjects with Hair fall. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C3B02404; Version: 01, Dated 02 Aug 22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parth Joshi 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  8000085049  
Fax  917966219549  
Email  pjoshi@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parth Joshi 
Designation  Principal Investigator 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India


GUJARAT
380054
India 
Phone  8000085049  
Fax  917966219549  
Email  pjoshi@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Sethi 
Designation  Director - Consumer Research 
Affiliation  Cliantha Research  
Address  Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9825784942  
Fax  917966219549  
Email  ssethi@cliantha.com  
 
Source of Monetary or Material Support  
Cliantha Research, Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India 
 
Primary Sponsor  
Name  Ikaria Wellness Pvt Ltd 
Address  412-B, The Capital, Bandra Kurla Complex, Mumbai – 400051 Maharashtra  
Type of Sponsor  Other [Health and Hygiene] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parth Joshi  Cliantha Research   Consumer Research Department, Garden View Corporate House No 7, Opp Auda Garden, Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT 		 8000085049
917966219549
pjoshi@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects with 50 to 100 hair fall and thin hair will be included in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Nyumi Happy Hair Gummies  Simply chew and swallow 2 gummies together after dinner for 90 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Subjects having 50 to 100 hair fall per day.
2.Females with at least 50 count of hair fall and Males with 30-50 count of hair fall from hair combing method. (60-sec hair count)
3.Subjects with thin hair.
4.Male subjects with minimum hair length of 2 inches will be included. 
 
ExclusionCriteria 
Details  1.History of any dermatological condition of the scalp other than hair loss and/or dandruff.
2.Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
3.Subjects who have undergone hair growth treatment within 3 months before screening.
4.Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Anagen and telogen ratio (A:T ratio) by hair pluck test and microscopic evaluation   baseline i.e., Day 01 and after treatment on Day 90 (plus 2 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Hair thickness, Hair density and Hair growth by CASlite Nova  baseline on Day 01 and after treatment on Day 50 (plus minus 2 Days) and Day 90 (plus 2 days). 
Hair Fall Reduction by counting no. of hair break after 60 second combing method   screening visit, baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)  
Hair Strength by Hair Pull Test   baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Hair Gloss by Glossymeter  baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Change in general appearance of scalp hair i.e. Hair Volume (Full – Medium – Small), Hair Density (Dense – Thinned/Shed) and Hair Shininess (Poor – Average – Good) by Dermatologist   baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Change in general appearance of scalp skin i.e., itchiness, redness, roughness and scaliness of scalp by Dermatologist  baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Nail brittleness on the basis of Global improvement rating performed by the Dermatologist  baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Nail growth and nail health satisfaction by using 0-10 VAS scale   baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Product perception   Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
Subject Satisfaction Questionnaire  Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days) 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/08/2022 
Date of Study Completion (India) 14/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="2" 
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  

This is an open label, single arm, clinical study to evaluate efficacy and safety of Chewable Gummies in healthy adult subjects with Hair Fall.

Study will consist of total (08) visits.

Visit 01: Screening Visit (07 days prior to Day 01)

Visit 02: For Shaving of Test Area (03 days prior to Day 01)

Visit 03: Enrolment Visit – Baseline Assessment i.e., Day 01

Visit 04: Evaluation Phase i.e., Day 25 (+ 2 Days)

Visit 05: For Shaving of Test Area i.e., Day 47 (± 2 Days) (03 days prior to Day 50)

Visit 06: Evaluation Phase i.e., Day 50 (± 2 Days)

Visit 07: For Shaving of Test Area i.e., Day 87 (± 2 Days) (03 days prior to Day 90)

Visit 08: Evaluation Phase and End of Study i.e., Day 90 (+ 2 Days)

 
Close