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CTRI Number  CTRI/2022/02/040209 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On: 21/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ayurvedic Hair Oil]  
Study Design  Single Arm Study 
Public Title of Study   To determine safety and effect of the Ayurvedic Hair Oil in management of Hair Fall Control in healthy adult human subjects with hair fall.  
Scientific Title of Study   A Safety and Efficacy study of an Ayurvedic Hair Oil in Management of Hair Fall (Khalitya) Control in Healthy Adult Human Subjects with Hair Fall (Khalitya). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NB210008-VPL Version 01 Date 24Jan22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office No. A-206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  Office No. A-206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar


GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office No. A-206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar

Gandhinagar
GUJARAT
382421
India 
Phone  91-79-48983895  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Private Limited Office No. A-206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar 382421, Gujarat, India 
 
Primary Sponsor  
Name  Vedistry Private Limited 
Address  501-A, Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018, Maharstra, India  
Type of Sponsor  Other [FMCG Manufacturer, Distributer, Selling] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maheshvari Patel  NovoBliss Research Private Limited  Office No. A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat, India
Gandhinagar
GUJARAT 		 91-79-48983895

maheshvari@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adult Human Subjects with complaints of Hair Fall (Khalitya) 
Patients  (1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Apply Ayurvedic hair oil thrice a week for continuous 60 days (8 weeks) to hair and scalp, massage the scalp after oil application for 10 mins with fingertips in a circular motion and leave for an hou, Ritucarya: Not Applicable, Acara Rasayana:Not Applicable, Other:Not Applicable , Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 45 years (both inclusive) at the time of consent.
2) Sex: Healthy males and non-pregnant/non-lactating females.
3) Females of childbearing potential must have a self-reported negative pregnancy test.
4) Subjects are generally in good health.
5) Females with 40-50 counts and males with 25-30 counts of hair fall from the hair combing method (60-sec hair count) at the screening visit 1 before treatment.
6) Subject has mild to moderate dandruff on scalp determined by ASFS score 24 to 48 with itching and flaking at the screening visit.
7) Subjects have unwashed and untreated scalp for 5 days.
8) All hair colors except grey hair.
9)  Subject has hair length long enough to pluck the hairs.
10) The subject who does head massage.
11) Subjects with self-proclaimed nonpathological thinning of hair.  
12) Subjects willing to give written informed consent and willing to follow study procedure.
13) Subjects who have used other marketed products for hair fall control in past.
14) Willing to refrain from any other treatment for the main indications for which the study test product is being given during the study.
15) Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-hair fall agents) or any other hair growth, hair fall treatment, hair products other than the test product for the entire duration of the study.
16) Willing to use test products throughout the study period. 
 
ExclusionCriteria 
Details  1) Subjects with a history of severe hair fall due to any clinically significant problems/s like anemia, thyroid problems, etc.
2) History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3) History of prior use of scalp hair growth treatment within 3 months.
4) History of any prior hair growth procedures (e.g., hair transplant or laser).
5) Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
6) History of alcohol or drug addiction.
7) Subjects using other marketed hair fall control and/or hair growth products during the study period.
8) Subjects who have plans of shaving of scalp hair during the study.
9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
11) Subjects having a history or present condition of an allergic response to any cosmetic products.
12) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
13) Pregnant or breastfeeding or planning to become pregnant during the study period.
14) History of chronic illness which may influence the cutaneous state.
15) Subjects participating in other similar cosmetics, device or therapeutic trials or hair / scalp care products within the last four weeks  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Mean Percentage change in hair fall (Khalitya) reduction after 4 and 8 weeks of the application using 60 seconds hair count technique
2) To assess the effect of test treatment in terms of change in hair growth on the scalp using CASlite nova
3) To evaluate the effectiveness of test product on reduction in Adherent scalp flaking score  		 1) Baseline on Day 1 before application to Day 30 and Day 60 after applications
2) Baseline visit (04 days before Day 01) and Visit 2 (Day 01) before application to Visit 03 (Day 27) - Visit 04 (Day 30) and Visit 05 (Day 57) - Visit 06 (Day 60) after application
3) Baseline on Day 01 before application to Day 30 and Day 60 after application 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of test treatment in terms of change in the general appearance of hair (Hair volume, hair density, hair plasticity, hair smoothness, hair oiliness, shininess)
Hair Volume: Full - Medium - Small
Hair Density: Dense - Thinned/Shed
Hair Plasticity: Waved - Flat
Hair Smoothness: Poor - Average - Good
Hair Oiliness: None - Mild - Moderate - Excessive
Hair Shininess: Poor - Average - Good 		 Baseline on Day 1 before application to Day 30 and Day 60 after applications 
To assess the effect of the test treatment in terms of hair Strength (poor, average, good)   Baseline on Day 1 before application to Day 30 and Day 60 after applications 
To assess the effect of test treatment in terms of product perception   Baseline on Day 1 before application to Day 30 and Day 60 after applications 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2022 
Date of Study Completion (India) 10/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
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, single-centre, safety and efficacy, a clinical study of ayurvedic hair oil in the management of hair fall (Khalitya) control in Healthy Adult Human Subjects with Hair Fall (Khalitya) after usage of consecutive 8-weeks.


In this study, a detailed sample size calculation has not been performed. Considering proof of concept study and based on the sponsor’s recommendations 30 completed subjects (32 enrolled) are kept.


A total of up to 32 subjects will be enrolled to get 30 evaluable subjects [preferably equal number of males and females] in the study.


The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.

There will be 06 visits during the conduct of the study. The duration of the study will be 60 Days (+2 days) from enrolment.

Visit 01 (Day -04): Screening Visit (Within 4 days before enrolment on Day 01), Enrollment,  & Tattoo on Scalp, Hair Growth Measurement, 60s Combing test

Visit 02 (Day 01): Hair Growth Measurement, Evaluation Visit, Treatment Phase start

Visit 03 (Day 27): Treatment Phase, Evaluation Visit (Day 27 i.e., 03 days before visit 04), Hair Growth Measurement

Visit 04 (Day 30): Treatment Phase, Evaluation Visit, Hair Growth Measurement [Week 4]

Visit 05 (Day 57): Treatment Phase, Evaluation Visit (Day 57 i.e., 03 days before visit 04), Hair Growth Measurement

Visit 06 (Day 60): Evaluation Visit, Hair Growth Measurement, End of Study [Week 8]


 
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