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CTRI Number  CTRI/2024/12/077703 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical study to see the effect of Ayurvedic taila locally in the management of khalitya with reference to hairloss 
Scientific Title of Study   A Randomized Controlled clinical study to evaluate the efficacy of Dhurdhuradi taila topically in the management of khalitya with W.S.R to hairloss 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankit Haribhau Mahajan  
Designation  MD kayachikitsa scholar 
Affiliation  Dr VJD gramin ayurvedic mahavidyalaya College  
Address  OPD no 3 Department of Kayachikitsa,Dr VJD gramin ayurvedic mahavidyalaya near renuka matta mandir , Patur, District - Akola, state - Maharashtra , Country - India

Akola
MAHARASHTRA
444501
India 
Phone  7972939765  
Fax    
Email  ankithmahajan444@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish Keche  
Designation  Associate Professor  
Affiliation  Dr VJD gramin ayurvedic mahavidyalaya College  
Address  OPD no 3 Department of Kayachikitsa Dr VJD gramin ayurvedic mahavidyalaya near renuka matta mandir , Patur, District - Akola, state - Maharashtra , Country - India

Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Keche  
Designation  Associate Professor  
Affiliation  Dr VJD gramin ayurvedic mahavidyalaya College  
Address  OPD no 3 Department of Kayachikitsa Dr VJD gramin ayurvedic mahavidyalaya near renuka matta mandir , Patur, District - Akola, state - Maharashtra , Country - India

Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya Patur Akola  
 
Primary Sponsor  
Name  Department of Kaya chikitsa,Dr VJD gramin Ayurved Mahavidyalaya  
Address  Dr VJD gramin ayurvedic mahavidyalaya near renuka matta mandir , Patur, District - Akola, state - Maharashtra , Country - India 
Type of Sponsor  Private medical college 
 
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 Ankit Haribhau Mahajan   Dr.VJD Gramin Ayurved Mahavidyalaya  OPD no 3 Department of Kayachikitsa Dr VJD Gramin Ayurvedic Mahavidyalaya near renuka mata mandir Patur Dist Akola Maharashtra
Akola
MAHARASHTRA 
7972939765

ankithmahajan444@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Akola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L639||Alopecia areata, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical
2Comparator Arm (Non Ayurveda)-Minoxidil Minoxidil 5%
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients with signs and symptoms of Hairloss (Khalitya) will be selected.
2. Age group 18-40 years.
3. Chronicity less than 1 year.
4. Patients will be selected who are willing to give informed consent and ready to
comply with the protocol. 
 
ExclusionCriteria 
Details  1. Subjects with severe Hair fall due to any clinically significant disorders like
anemia, thyroid disorders ,DM disorders ,cancer etc.
2. Subject with severe dermatological disorders of the scalp that might interfere
with the study evaluation.
3. Subjects with recent disease history like malaria, typhoid, jaundice & scalp
diseases.
4. Patients who have been diagnosed to have local disease like Alopecia totalis,
Tinea capitis , folliculitis decalvans and in Ayurvedic terms patients of Arunshinka,
Indralupta.
5. Subjects who have regularly used anti-hair fall treatment with hair oils over the
last 6 months.
6. Subjects who have previously undergone hair transplantation procedures. 7.
Menopausal Women.
8. patients below 18 and patients above 40 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Hairfall ( Khalitya)
2. Itching ( Kandu )
3. Roughness (Rukshata)
Symptoms will be decreased  
1. Hairfall ( Khalitya)
2. Itching ( Kandu )
3. Roughness (Rukshata)
Symptoms will be decreased  
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms of Khalitya  18 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   16/12/2024 
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="6"
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   Healthy, long and vibrant hair helps lot in improvement of personality. A
Therefore, to keep hair in healthy state is entirely duty of human being,
because just like face, hair is also a mirror of healthy state of body. In this
advanced modernized era, the humans are gifted with lot of sophistication,
luxuries but at the same time left with sedentary life style, stress induced hectic
schedules along with faulty dietary habits. These all habits influences the
homeostasis of the body and with many other health problems, fall is one of
them. Problem of falling of hair is progressively increasing in society which is also
affecting quality of life. Many years of hair loss have impact on mental healt
 The concept of beauty (Soundarya) is gaining more and more attention
globally and hair plays an important role in it, as it has been said that hair is a
parameter of one’s beauty. Healthy, beautiful, long and attractive hairs add
charm to the personality. It adds a great aesthetic value and it is the crowning
glory of any person. Not only has that hair had protective function also. Head
hair protects the scalp against the burning sun and helps hold in body heat. Hair
gives insulation, protection from external factors friction buffer, differentiation
and beautification and redirect sweat and water.
 Hair is one of the defining characteristics of mammals. A human has around
more than 2 million hair follicles which have both positive as well as negative
effect on skin health. It is one of the vital parts of our body which is derived from
the ectoderm of the skin; it is work as a protective appendage for the body. Hair
loss is silent but devastating problem which may occur to a healthy person also.
It has been regarded as geriatric physiological phenomena, generally after the mid-forties. Early hair fall has been attributed to be the result of varied factors
like hormonal imbalance, faulty hair care, pollution etc.
 Hair fall is a universal problem, having affected both sexes of all races to
different extents for as long as mankind has existed. For thousands of years, men
and women of all countries and races have shared the tragedy of pre-mature hair
loss. Various factors contribute to hair fall/loss. Genetic predisposition and
hormonal factors predominantly contribute to the above. Apart from hormonal
factors, other reasons for hair loss in both the sexes can be stress, improper
nutrition (A common reason for hair loss in women of all ages is improper
nutrition), especially a lack of iron and protein, which are essential for
maintaining healthy hair growth. Underlying medical conditions
like diabetes or lupus, diseases such as typhoid, malaria, jaundice etc,also cause
hair fall. The use of chemotherapeutic agents also causes hair fall.
 In Ayurvedic approach, loss of hair is coined out as in term of “Khalitya”
under the broad heading of Shiroroga .
 The changes in hair follicle density, size and/or changes to the hair growth
cycle are the fundamentally causes of hair disorders. Hair loss, also known as
alopecia is a loss of hair from the head or body.
 
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