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CTRI Number  CTRI/2013/11/004161 [Registered on: 21/11/2013] Trial Registered Retrospectively
Last Modified On: 18/02/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [External Hair Oil]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the efficacy of herbal hair oil. 
Scientific Title of Study   A randomized controlled study comparing Herbal hair oil with coconut oil for the promotion of Hair growth in healthy adult volunteers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Brindha 
Designation  Associate Dean & Co-ordinator 
Affiliation  SASTRA University 
Address  Centre for Advanced Research in Indian System of Medicine SASTRA University

Thanjavur
TAMIL NADU
613401
India 
Phone  09443330487  
Fax    
Email  brindha@carism.sastra.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr P Brindha 
Designation  Associate Dean & Co-ordinator 
Affiliation  SASTRA University 
Address  Centre for Advanced Research in Indian System of Medicine SASTRA University

Thanjavur
TAMIL NADU
613401
India 
Phone  09443330487  
Fax    
Email  brindha@carism.sastra.edu  
 
Details of Contact Person
Public Query  
Name  Dr C Savariraj Sahayam 
Designation  Assitant Professor 
Affiliation  SASTRA University 
Address  Centre for Advanced Research in Indian System of Medicine, SASTRA University

Thanjavur
TAMIL NADU
613401
India 
Phone  09443661936  
Fax    
Email  drsagay@gmail.com  
 
Source of Monetary or Material Support  
Kaleesuwari Refinery Pvt. Ltd. 
 
Primary Sponsor  
Name  SASTRA University 
Address  Centre for Advanced Research in Indian System of Medicine, SASTRA University, Thanjavur 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Kaleesuwari Refinery Pvt Ltd  #53, Rjasekaran street, (opp Radhakrishnan Salai), Chennai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Vinnarasan  Thanjavur Medical College Hospital  Dermatology OPD, Thanjavur Medical College Hospital, Thanjavur
Thanjavur
TAMIL NADU 		 09443173632

deva.ayur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Thanjavur Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hair growth/Hair fall control  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coconut oil  10 ml per day for 3 months topically 
Intervention  Herbal Hair Oil  10 ml per day for 3 months topically 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  36.00 Year(s)
Gender  Both 
Details  1. be informed of the nature of the study and will be asked to give a written consent
2.To have body weights within 25% of the appropriate weight range,
3. Must be free from significant diseases or clinically significant abnormal laboratory values during screening,
4. Normal ECG
5. Should not be taking any other treatment for hair growth
6. Must be able to communicate effectively with study personnel
7. hair fall due to chemotherapy 
 
ExclusionCriteria 
Details  1. Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
2. History of allergic conditions – asthma, urticaria, eczema.
3. History of autoimmune disorders – lupus erythematosis (SLE)
4. History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
5. History of psychiatric disorders.
6. Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
7. Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period.
8. Androgenic alopecia
9. Presence of clinically significant abnormal laboratory results during screening.
10. Use of any recreational drugs or a history of drug addiction.
11. History of Anaemia
12. History of Dandruff, Head lice and pediculosis
13. History of irregular menstruation and PCOD
14. History of Hypo and Hyper Thyroidism.
15. History of Diabetes 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase in hair length, reduction of hair loss and promotion of new hair growth  Increase in hair length, reduction of hair loss and promotion of new hair growth 
 
Secondary Outcome  
Outcome  TimePoints 
Marketing of Evidence based Herbal hair oil for personal care  one year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   19/11/2013 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
STUDY OBJECTIVES:
To investigate the efficacy of Herbal hair oil in healthy adult volunteers by assessing the gross hair growth and counting the number of active hair follicles on the scalp.
STUDY DESIGN:
  A randomized study over a 3-months period.  Volunteers will be screened and eligible subjects during Visit 1 will be randomized to either Herbal hair oil b.i.d or Coconut oil b.i.d of similar appearance. Visits 2, 3, 4, 5 and 6 (final) will be scheduled at monthly intervals. Safety tests will be repeated at each of the study visits (except visit 2).  Patients will enter adverse events and daily use of study medication in a subject diary. This will serve as a measure of compliance.

Efficacy Assessment:

Overall efficacy assessment of hair oil is based on four point scale (i.e. bad, average, good & excellent) for hair & scalp related ailment. Patient will be undergoing monthly follow up for 3 months on the basis of following criteria:

a.       Effectiveness – Hair growth/Hair fall control

b.      Promotion of  hair growth will be measured using trichoscopy
c.       Hair strength: tensile strength will be measured using Uni axial mechanical testing machine collecting hair of 5 cm long
Analysis of scalp photograph: Trichoscopy data of all subjects from each group will be compared to check the efficacy of treatment along with tensile strength.  
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