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CTRI Number  CTRI/2025/06/089566 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety, Efficacy Study]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to assess safety and effectiveness of three different hair growth oils in subjects with baldness. 
Scientific Title of Study   A prospective, multi-centre, randomized, double-blind, placebo-controlled, three-arm interventional study to evaluate the safety, efficacy, and in-use tolerability of Hair Growth Oil(s) in subjects with mild to moderate androgenic alopecia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/CPD/027/2025 , 1.0 13June 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Sub Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad Ahmedabad, Gujarat, India - 382481. Gandhinagar GUJARAT 382421 India

Ahmadabad
GUJARAT
382481
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Sub Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad Ahmedabad, Gujarat, India - 382481. Gandhinagar GUJARAT 382421 India

Ahmadabad
GUJARAT
382481
India 
Phone  09909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshwari N Patel 
Designation  Director Operations and Strategic Management  
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
NovoBliss Research Pvt. Ltd.
Ahmadabad
GUJARAT
382481
India 
Phone  09909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Makali, Bengaluru 562 162, India 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Makali, Bengaluru 562 162, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alka Makvana MD   ARISTA SKIN CLINIC   F 16 Shukan Status Apartments Near Satyam Hospital Gota
Ahmadabad
GUJARAT 		 79489 83895

consultant@novobliss.in 
Dr Apeksha Merja MD   ENLIVEN SKIN MD CLINIC   2nd floor B Block Shakti ETC Pantaloons
Ahmadabad
GUJARAT 		 79489 83895

dermatology@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 male and female participants  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HHO   Mode of Usage: Apply the oil directly on the scalp using a comb applicator. Leave it on for a minimum of 30 minutes or can be left overnight. Rinse off with a gentle shampoo. Storage Conditions: Store at room temperature 15°C to 30°C, away from sunlight. Frequency: For effective results use 3 times a week for 3 months Route of administration:Topical Duration: 90 Days  
Intervention  IHO   Mode of Usage: Apply the oil directly on the scalp using a comb applicator. Leave it on for a minimum of 30 minutes or can be left overnight. Rinse off with a gentle shampoo. Storage Conditions: Store at room temperature 15°C to 30°C, away from sunlight. Frequency: For effective results use 3 times a week for 3 months Route of administration: Topical Duration: 90 Days 
Comparator Agent  Nil   NA 
Intervention  PHO   Mode of Usage: Apply the oil directly on the scalp using a comb applicator. Leave it on for a minimum of 30 minutes or can be left overnight. Rinse off with a gentle shampoo. Storage Conditions: Store at room temperature 15°C to 30°C, away from sunlight. Frequency: For effective results use 3 times a week for 3 months Route of administration:Topical Duration: 90 Days  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Age: 25 to 50 years and above (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4) Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Subjects having mild to moderate androgenic alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification for male and Ludwig pattern scale for female.
6) Subjects who are on contraceptive/hormonal therapy must be able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
8) Subjects are willing to give written informed consent and are willing to follow the study procedure.
9) Subjects who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
10) Willing to use test products throughout the study period.
11) Subject is willing and able to follow and allow study staff to performed study test methods.
12) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
13) Subject must be able to understand and provide written informed consent to participate in the study.


 
 
ExclusionCriteria 
Details  1) Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
2) Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
3) Subject have history of any prior hair growth procedures done (e.g. hair transplant or laser).
4) Subject who had taken topical product of hair loss for at least 4 weeks before enrolment.
5) Subject who had taken any systemic product for any illnesses for at least 3 months.
6) History of alcohol or drug addiction.
7) Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8) Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
9) Pregnant or breast feeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state.
11) Subject have participated any clinical research study related to hair care products.
12) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or product of any type of cancer within the last 6 months.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of the test products from baseline in both the affected target area of the scalp and the healthy scalp tattoo-marked area, within each product arm and across product arms.
1. Hair Growth Rate
2. Hair Density and Hair Thickness
3. Anagen: Telogen Ratio  		 1. Improvement in hair growth rate evaluated through CASLite Nova or TrichoScanDB 5.0 at four time points — 4 days prior to Day 01, on Day 01, Day 87, and Day 90 (i.e., 3 days post Day 87).
2. Improvement in hair thickness, density and anagen: telogen ratio evaluated through CASLite Nova or TrichoScanDB 5.0, from baseline (Day 01, prior to product usage) to post-product usage time points on Day 30 (±2 days), Day 60, and Day 90 (±2 days).
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of the test products by assessing the change in hair fall (from scalp root & due to hair breakage) from baseline before & after usage of the test products arm & across product arms.  Baseline, Day 30, Day 60, Day 90. 
To assess the efficacy of the test products by evaluating changes in the total hair count on the vertex (head crown) region of the scalp using standardized digital photography captured at a 90° angle & analyzed through image analysis, from baseline to post-product, within each product arm & between product arms.  Baseline, Day 30, Day 60, Day 90 
To evaluate the efficacy of the test products in terms of change in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair dryness, hair strength from baseline before & after usage of the test products arm & across product arms.  Baseline, Day 30, Day 60, Day 90 
To evaluate the efficacy of the test products in terms of change in general appearance of scalp i.e. Itchiness, redness, roughness, scaliness & dryness from baseline before & after usage of the test products arm & across product arms.  Baseline, Day 30, Day 60, Day 90 
To evaluate the efficacy of test products in terms of change in tensile strength of hair from baseline before & after usage of the test products arm & across product arms across product arms.  Baseline, Day 30, Day 60, Day 90 
To evaluate the efficacy of test products in terms of change in hair strength from baseline before & after usage of the test products arm & across product arms.   Baseline, Day 30, Day 60, Day 90  
7. To assess the absorption (for Non-sticky & non-greasy hair) of the test products following application, both within each product arm & comparatively across product arms.  Day 01 T20min 
To evaluate the efficacy of the test products in terms of product perception questionnaire from both within product arm & between product arms.   Baseline, Day 30, Day 60, Day 90 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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   N/A 
Date of First Enrollment (India)   07/07/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, three-arm interventional study designed to evaluate the safety, efficacy, and in-use tolerability of hair growth oil(s) in subjects diagnosed with mild to moderate androgenic alopecia.

A total of 165 healthy male and non-pregnant/non-lactating female subjects (preferably in an equal gender ratio), aged between 25 to 50 years (inclusive), will be enrolled across the three arms (55 subjects per arm). Of these, 132 subjects (44 per arm) are expected to complete the study.

·         CASLite Nova or TrichoScanDB 5.0: Measures Hair density, hair thickness, hair growth rate

·         TESTRONIX tensile tester: Tensile strength of single Hair strand/subject

·         60 Secs Hair Combing Test – Hair fall from scalp root and hair fall due to breakage

·         Hair Pluck Test: Measures Anagen : Telogen Ratio

·         Hair Pull Test: Measures Hair Strength 

·         Dermatologist Assessments:

-      Norwood and Hamilton Scoring for males, Ludwig Scoring for females

-      General Appearance of Hair à Hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair dryness, hair strength.

-      General Appearance of Scalp à Itchiness, redness, roughness, scaliness

·         Digital Photographs of Head Crown using Nikon Digital D3300 Camera or equivalent

·         Image Pro Software – Head crown photography image analysis for number of new hair, baby hair etc.

·         Subject perception questionnaire

 
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