FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/016045 [Registered on: 16/10/2018] Trial Registered Prospectively
Last Modified On: 12/10/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Follicles Regen in treatment of excessive hair fall  
Scientific Title of Study   A randomized, double blind, active controlled comparative study to assess the efficacy and safety of a Follicles Regen in treatment of excessive hair fall 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shihiji Srivastava 
Designation  Cosmetic Phycian 
Affiliation  Elite Aesthetic and Cosmetic Clinic 
Address  E 311 Greater Kailash -2
E 311 Greater Kailash -2
South
DELHI
110048
India 
Phone  9205340090  
Fax    
Email  drelite27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nidhi Singh 
Designation  Head Clinical Operation 
Affiliation  Clinical Research Network India 
Address  Inox Tower, New Bridge Centre, Sector 16A Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7906261455  
Fax    
Email  nidhiray46@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi Singh 
Designation  Head Clinical Operation 
Affiliation  Clinical Research Network India 
Address  Inox Tower, New Bridge Centre, Sector 16A Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7906261455  
Fax    
Email  nidhiray46@gmail.com  
 
Source of Monetary or Material Support  
Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India 
 
Primary Sponsor  
Name  Gods Own Store LLP  
Address  A Amritpuri opp Iskcon Temple East of Kailash New Delhi India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Shihiji  Elite Aesthetic & Cosmetic Clinic  Room no 201, Clinical Research Unit, E 311 Greater Kailash -2
South
DELHI 		 9205340090

drelite27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good Society Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aromatic Amla oil   Subjects will be recommended to apply 5-10 mL of oil twice a week, for 3 months. 
Intervention  Follicles Regen oil   Follicles regen is primarily a unique blend of oils/extracts of Jojoba, Lavender, Rosemary, Carrot seed, Cedarwood, White Thyme, Frankincense. subjects will be recommended to apply 5-10 mL of oil twice a week, for 3 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants must be adults, aged 18-65 years old with complain of excessive hair fall or damage. At screening, subjects must complete questionnaires that would provide investigators with information on their medical and hair health history and demographics. Each subject’s hair length, styled layer length, average hair diameters, Hair Mass Index (HMI), Hair Breakage Index (HBI), and Healthy Hair Index (HHI) readings will be measured, calculated, and recorded.
2. Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
3. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
4. Participants must be willing to apply the test product and return for assessment visits for evaluation.
5. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications for hair fall or dandruff treatment.
6. Participants must agree to take healthy diet and life style.
 
 
ExclusionCriteria 
Details  1. Single or married subjects who are pregnant or have borne children in past one year.
2. Participants with a history of shampooing hair less than three times a week as part of their current hair care regimen.
3. Participants with a history of illness or fever in past few months OR greater than 20 percent weight loss in the past 12 months OR nutritional deficiency or being on a new diet in the past six months
4. Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders OR thyroid problems OR history of depression or severe anxiety in the past six months.
5. Participants with history of a scalp or hair loss disorder, such as alopecia, in the past 12 months
6. Patients reporting use of prescription or non-prescription drugs during the study period OR Willing to continue the use of their current hair oil.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. reduction in level of hair fall as measured by trichometer and subject self-assessment records as compared to the comparator
2. Improvement in the texture, shine and hair length.
3. Improvement in overall scalp health
 		 Baseline Day 0
Day 30
Day 60
Day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
Safety including documentation of all adverse events, clinically significant and serious adverse events (SAEs)   Baseline Day 0
Day 30
Day 60
Day 90 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="14" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Publication will be done post study completion as per Sponsor requirement. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study will enrol adults aged between 18-65 years that have been suffering from excessive hair fall. Eligible participants screened in baseline interview (assessment visit 1) will be randomized into two groups to be treated with either the test product Follicles Regen oil or comparator. The baseline interview will collect data such as age, level of dandruff, itching in scalp and Measurements of hair length, hair diameter, and Hair Mass Index. Hair Breakage Index and the Healthy Hair Index values will be calculated from the trichometer measurements, and subject self-assessment questionnaires. Subjects will be evaluated on first, second and third month (assessment visits) subsequent to the initiation of treatment. Safety analyses will be done at each visit.

 
Close