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CTRI Number  CTRI/2021/03/031648 [Registered on: 01/03/2021] Trial Registered Prospectively
Last Modified On: 22/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   AYURVEDIC TREATMENT FOR HAIRFALL 
Scientific Title of Study   “OPEN LABLE CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIPHALADI TAILA NASYA AND SHIROABHYANGA IN THE MANAGEMENT OF KHALITYA” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnnapurna Behera 
Designation  PG scholar 
Affiliation  Shree Jagadguru gavisidheswar ayurveda college and hospital  
Address  Room no 01 department of shalakya tantra Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231

Koppal
KARNATAKA
583231
India 
Phone  8763194964  
Fax    
Email  dr.annapurnabehera123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVeerayya R HIremath 
Designation  Professor and Hod & guide 
Affiliation  Shree Jagadguru gavisidheswar ayurveda college and hospital  
Address  Room no 01 department of shalakya tantra Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrVeerayya R HIremath 
Designation  Professor and Hod & guide 
Affiliation  Shree Jagadguru gavisidheswar ayurveda college and hospital  
Address  Room no 01 department of shalakya tantra Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Source of Monetary or Material Support  
DrAnnapurna behera PG scholar Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231 
 
Primary Sponsor  
Name  Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal 
Address  PG scholar Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231 
Type of Sponsor  Research institution and hospital 
 
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 
DrAnnapurna behera  Shree Jagadguru gavisidheswar ayurveda college and hospital   department of pg studies in shalakya tantra Shree Jagadguru gavisidheswar ayurveda college and hospital gavimutt campus koppal-583231
Koppal
KARNATAKA 
8763194964

dr.annapurnabehera123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL CLINICAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Triphaladi taila  Shiroabhyanga with Triphaladi taila QS 14 days Nasya with Triphaladi taila 8drops 14 days.  
Comparator Agent  Yastimadhu taila  Shiroabhyanga with Yastimadhu taila QS 14 days Nasya with Ystimadhu taila 8drops 14 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) Patients aged between 18-45years of either sex.
2) Patients having sign symptoms of khalitya
 
 
ExclusionCriteria 
Details  1)Patients who have disease like Alopecia Totalis, Tinea Capitis.
2) Patients of Arunshika, Indralupta.
3)Patients suffering from any systemic disease like Hormonal disorders, Anemia, Cancer etc.
4)Patients who are unfit for nasya karma & shiro abhyanga.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduced hairfall   14 days 
 
Secondary Outcome  
Outcome  TimePoints 
complete absence of hair fall  28th day 
 
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 2 
Date of First Enrollment (India)   01/03/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hair has significant role in beauty and personality for both male and female. Hair loss is one of the most common problems faced by people across all age groups and has been estimated to affect nearly 2% of the world’s population. This is why hair fall remedies are billion-dollar industry.

The term Alopecia means nothing than loss of hair and is a sign rather than a diagnosis. Thinning, loss or involution of hair. Cicatrical and non cicatrical alopecia. cicatrical alopecia associated with scarring and thus destruction of hair follicles, hence irreversible. It has been regarded as geriatric physiological phenomena and generally after the mid-forties. Each hair grows in three cyclic phase i.e Anagen, Catagen, Telogen. Anagen is growing phase hairs. Catagen is involution phase. Telogen is the resting phase.  Corticosteroids, scalp surgery and autologous hair transplants are the modern managements.

In Ayurveda, hair loss problem has been described as khalitya with detail treatment modalities. Acharya charaka describes that tejas combining with vata adi dosha reaches the shira kapala and causes hair fall by dahana of romakupa . Acharya sushruta also mentioned the same nidana and samprapti as charaka but under kshudra roga. The treatment modalities include nasya, shiroabhyanga, shiro lepa and sodhana chikitsa.

           Hormonal therapy and hair transplant are not free from side effects and are costlier, Ayurveda has safe, effective and cost-effective treatment for it. Hence present study Triphaladi taila shiroabhyanga and nasya in management of khalitya has been taken up. Yastimadhu taila  shiroabhyanga and nasya is the control group.

 
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