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CTRI Number  CTRI/2020/04/024824 [Registered on: 23/04/2020] Trial Registered Prospectively
Last Modified On: 22/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Siddha 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the Safety and Efficacy of Investigational Hair oil in comparison with coconut oil and comparator Hair oil in subjects with mild to severe Hair fall 
Scientific Title of Study   A Prospective study to evaluate the Safety and Efficacy of Investigational Hair oil in comparison with coconut oil and comparator Hair oil in subjects with mild to severe 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 M S Ramasamy 
Designation  Trail Coordinator 
Affiliation  Sanjeev Biomedical Research Center 
Address  Sanjeev Biomedical Research centre No 3/S1 Amudham Flats,Herbal department,ayurvedic division department , Keelkatalai Chennai
Sanjeev Biomedical Research centre Herbal department,ayurvedic division,No 3/S1 Amudham Flats, Keelkatalai Chennai
Chennai
TAMIL NADU
600117
India 
Phone  9176049309  
Fax    
Email  director@sanjeevbiomed.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh sharma 
Designation  Medical Writer 
Affiliation  I5 Clinical Research Pvt Ltd 
Address  IDD Research solutions Pvt Ltd Research Department No 15, Viswasa Nagar, First Floor Maduravoyal Chennai
IDD Clinical Research solutions Pvt Ltd Research Department No 15, Viswasa Nagar, First Floor Maduravoyal Chennai
Chennai
TAMIL NADU
600095
India 
Phone  9717832255   
Fax    
Email  yogesh@iddresearch.com  
 
Details of Contact Person
Public Query  
Name  Keerthica C 
Designation  Study Manager 
Affiliation  I5 Clinical Research Pvt Ltd  
Address  IDD Research Solutions Pvt Ltd No 15, Viswasa Nagar, Research department , First Floor Maduravoyal Chennai
IDD Research solutions Pvt Ltd No 15, Viswasa Nagar, Research department, First Floor Maduravoyal Chennai
Chennai
TAMIL NADU
600095
India 
Phone  8056271368  
Fax    
Email  keerthica.chandrasekar@iddresearch.com  
 
Source of Monetary or Material Support  
Thai Herbals No. 9 Fifth Cross St, Vijaya Ragavapuram, Saligramam Post Chennai - 600093  
 
Primary Sponsor  
Name  Thai Herbals 
Address  No. 9 Fifth Cross St, Vijaya Ragavapuram, Saligramam Post Chennai - 600093  
Type of Sponsor  Other [Ayurvedic Cosmetic company] 
 
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 Radha K R  Singhvi Health center  Singhvi Health center No 127 Mint Street, Research department, clinical division Sowcarpet Chennai
Chennai
TAMIL NADU 		 9176049309

drradhakr770@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ashwin Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hairfall 
Patients  (1) ICD-10 Condition: L63||Alopecia areata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ayurvedic Hair Oil  Ayurvedic Hair oil Study duration - 6 weeks Regular Usage 
Comparator Agent  Coconut Oil  Coconut oil Study duration - 6 weeks 
Intervention  Pramika Hair Oil  Pramika Hair oil (A Siddha Proprietary Formulation) Study duration - 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Willingness to give written informed consent
2.Subjects with mild to severe hair fall. (Severe -50 percent, moderate-30 percent,mild- 20 percent)
3.Subjects with no skin allergies to any cosmetic products
4.Willingness to discontinue any hair care product other than the IP throughout the study.
5.Subjects who is not willing to color their hair throughout the treatment period
6.Subjects willing to discontinue all the hair care treatments such as hair spa,straightening, curling, hair perming, etc. throughout the treatment period
7.Willingness to follow the protocol requirements as evidenced by written
informed consent
8.Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure
9.In addition, female subjects selected for the study must be able to use a
medically acceptable form of birth control during the study or be surgically sterile or be post menopausal for at least 1 year
 
 
ExclusionCriteria 
Details  1.Subjects with known hypersensitivity to any specific ingredients of IP’s
2.Subjects below the age of 18 years and subjects above 50 years
3.Subjects not willing to participate in the study
4.Subjects who have previously undergone hair transplantation procedures
5.Subjects with other skin diseases.
6.Subjects are being treated for hair fall or severe active infection of any type.
7.Presence of any underlying significant uncontrolled medical illness involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic,immunologic, hematological, endocrine, or nervous systems or psychiatric disease, HIV.
8.Subjects with pre-existing scalp disorder such as scalp psoriasis, lichen planus, lichen planopilaris, DLE-Discoid lupus erythematosus, sebopsoriasis will be excluded from the study.
9.A female subject who is breast-feeding, pregnant or intends to become pregnant during the study.
10.Participating in a clinical research trial within 30 days prior to screening.
11.Subjects who are cognitively impaired and/or who are unable to give informed consent
12.Any other health or mental condition that in the Investigator’s opinion may adversely affect the ability to complete the study or its measures or that may pose significant risk to the subject.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Hair fall Reduction
2.Hair growth stimulation
3.Growth of existing hair
4.New hair growth
5.Hair damage protection
6.Shine and health of hair
7.Cooling effect
8.Dandruff control
 		 Visit1 day1
Visit2 day7
Viist3 day10
Visit4 day15
Visit5 day21
Visit6 day28
Visit7 day42 
 
Secondary Outcome  
Outcome  TimePoints 
1.Visible hair fall reduction
2.Hair growth improvement -length and thickness

3.Reduction of hair damage -split ends and breakages

4.Improvements in hair strength and elasticity of hair
5. Texture and appearance softness, smoothness and shine

6.Scalp itching and dandruff

7.Product lightness and non-stickiness

8.Feedback on product smell and smell retention on hair
 		 Visit7 day 42 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   05/06/2020 
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="1"
Days="12" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   At screening on day 1 (Visit 1), Volunteers after giving written informed consent, will be given screening numbers and subjected to screening procedures. Eligible volunteers will be enrolled in the study and Medical History along with physical examination and demography will be collected.

All selected 40 subjects will be provided with  Investigational Hair Oil or Coconut oil or Comparator Hair Oil in 2:1:1 ratio (as per randomization chart). In each arm, the subjects will be instructed to use the oil (quantity depending upon the length of hair) daily after hair wash.

Subjects will be asked to massage the scalp and comb hair, shake the bottle well to evenly distribute the medicinal content. They will be instructed to do the following:
1.   Take 5ml of oil on palm and rub together, apply the oil onto scalp and from root to tip of hair.
2.   Massage well for 3-5 minutes and leave on. Use a mild shampoo once in every 3 days to wash hair.
3.   On other days wash hair with water alone if required

The subjects will be advised to stop the usage of any routine hair oil or any other hair care products for the entire study duration and  use  only the provided  IP  during  these  6  weeks  of study duration.

Assessment of the hair fall reduction, hair growth stimulation (both existing hair growth and new hair growth), hair damage protection, shine and health of hair , Cooling effect and dandruff control will be done by investigator during all the follow up visits in primary assessment sheet. (PAS). Adverse event recording will be done during all the visits.
Hair Test to analyze the tensile strength, porosity and cuticle alignment of hair strands, tug test, float test and slide test will be performed during each visit.
Assessment of visible hair fall reduction, hair growth in length and    thickness,    reduction    in    breakages    and    split    ends, improvements in hair strength (elasticity), hair shine, smoothness, texture and appearance, scalp itching, scaling, product lightness and non-stickiness will be filled during final visit in subject assessment sheet (SAS) by subjects.
Assessment of visible hair fall reduction, hair growth in length and thickness, reduction in breakages and split ends, improvements in hair strength (elasticity), hair shine, smoothness, texture and appearance, scalp itching and scaling will be assessed during final visit in investigator assessment sheet (IAS) by investigator.

Subject’s feedback on product smell, smell of hair after applying the product, existence of smell on the hair will be done using subject feedback sheet during final visit by subject.
On the follow up visits (Day 7, Day 10, Day 15, Day 21, Day 28 and Day 42), the subjects will be asked to inform the investigator in case they take any medication for any condition during the study term/Period.

 
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