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
|
|
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
|
|
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. |