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CTRI Number  CTRI/2021/01/030511 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 15/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management Of Alopecia  
Scientific Title of Study   A Comparative study to evaluate the added effect of Gokshuradi Lepa and Dhaturapatra Lepa after Prachanna in Indralupta 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soundarya N 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University Of Health Sciences, Bengaluru 
Address  Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560009
India 
Phone  9686681323  
Fax    
Email  soundaryareddy13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rathi S 
Designation  Associate Professor 
Affiliation  Rajiv Gandhi University Of Health Sciences, Bengaluru 
Address  Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560009
India 
Phone  8970779550  
Fax    
Email  drrathi.s@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soundarya N 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University Of Health Sciences Bengaluru 
Address  Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru
Bangalore
KARNATAKA
560009
India 
Phone  9686681323  
Fax    
Email  soundaryareddy13@gmail.com  
 
Source of Monetary or Material Support  
Dr.Soundarya.N 
Sri Jayachamarajendra Institute of Indian Medicine Hospital, Government Ayurveda Medical College Campus, Bengaluru-560009 
 
Primary Sponsor  
Name  Dr Soundarya N 
Address  Department of PG studies in Shalakya Tantra OPD,Room No-11.Government Ayurveda Medical College ,Dhanwantari Road Bengaluru 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Soundarya N  Sri Jayachamarajendra Institute Of Indian Medicine Hospital  Shalakya tantra OPD Room No-11, Government Ayurveda Medical College Campus, Dhanwantari Road Bengaluru
Bangalore
KARNATAKA 
9686681323

soundaryareddy13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Ayurveda Medical College,Bengaluru  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: KAPALA-ROGAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dhaturapatra Kalka lepa  Prachanna followed by Dhaturapatra kalka lepa once in 4 days for one month. 
Intervention  Gokshuradi lepa  Prachanna followed by Gokshuradi lepa once in 4 days for one month. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Alopecia areata [ Indralupta] anywhere in the scalp  
 
ExclusionCriteria 
Details  •Subjects with other form of Alopecia areata like Alopecia totalis and Alopecia universalis.
•Alopecia due to other scalp disorders like Tinea capitis, Trichotillomania, Tillogen effluvium and Traumatic alopecia.
•Subjectswith endocrine disorders eg: Hypothyroidism.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Gradings,
number of patches
measurement of patchy hair loss
skin texture over patchy hair loss 
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gradings
measurement of the patchy hair loss
number of patchy hair loss
skin texture over patchy hair loss 
3 months 
 
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   N/A 
Date of First Enrollment (India)   16/01/2021 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  soundaryareddy13@gmail.com

  6. For how long will this data be available start date provided 05-06-2021 and end date provided 05-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Alopecia areata is a dermatologic disease characterized in its limited form by circumscribed round or oval patches   of alopecia with well-demarcated borders between normal and affected scalp, there is no scale or induration of the scalp and no loss of follicular markings.1

As per the recent statistical data, Alopecia areata affects 0.1 to 0.2% of human population. It occurs in bothmale and female. It is most common in children and early adults.

It is seen that an incidence of Alopecia areata tends to be higher when associated with diseases affecting the immune system affecting like asthma, allergies, atopic dermal aliments and hypothyroidism.

In modern system of medicine, the treatment for hair fall has been showing less encouraging results, management is with corticosteroids internally and externally. Minoxidile, UVR, laser therapy,hormonal therapy and hair transplantation,etc.

Even though this type of conventional management is effective, it has got some side effects and also the cost of these treatments are high. This is an attempt to find outa better, affordable and cost effective treatment for Indralupta which is also free from side effects.

Alopecia areata is correlated with Indralupta in Ayurveda. It is characterized by sudden loss of hair from scalp.

Pitta associated with Vata gets localized in the Roma kupa and causes the hair fall, later onKapha doshais  associated with Rakta causes the obstruction to the hair roots and restricts their re growth.2

Prachanna helps in clearing the obstructed romakupas and vitiated rakta is expelled out. Prachanna drains out the vitiatedblood from the srotas and later when lepa is applied over the region it facilitates easy and faster absorption of the drug. Lepa applied over the scalp will be absorbed by the hair follicle which causes the pore’s to open up and helps in the growth of healthy hair.

 

Ashtangahrudaya explains Daturapatra lepa for Indralupta in Shiroroga pratishedha adyaya3and Madhava chikitsa explains gokshuradhi lepa.4both the drugs are readily available and cost effective, hence chosen for the study.



HYPOTHESIS:

NULL HYPOTHESIS

H0 : There is neither effect of Prachanna with Gokshuradi lepa nor Dhatura patra lepain the management of indralupta.


ALTERNATE HYPOTHESIS :

 

H1 : Prachanna with Gokshuradi lepa has significant effect than Dhatura patra lepa in the management of indralupta.

 

H2 : Prachanna with Dhatura patra lepa has significant effect than Gokshuradi lepa in the management of indralupta.


 

 
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