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CTRI Number  CTRI/2025/05/087073 [Registered on: 19/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of Yashtimadhu churna with Anu tail nasya in the management of Khalitya vyadhi 
Scientific Title of Study   Randomised open controlled Clinical study to evaluate the efficacy of Yashtimadhu churna with Anu tail nasya in Khalitya  
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 Pooja Ashok Khote  
Designation  PG scholar  
Affiliation  Yashwant ayurvedic college post graduate training and research centre Kodoli  
Address  Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India 
Phone  9503704923  
Fax    
Email  poojaak2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasundhara Borakhade 
Designation  Reader  
Affiliation  Yashwant ayurvedic college post graduate training and research centre Kodoli  
Address  Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India 
Phone  9822885710  
Fax    
Email  vasudha.borakhade@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Ashok Khote  
Designation  PG scholar  
Affiliation  Yashwant ayurvedic college post graduate training and research centre Kodoli  
Address  Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur Kayachikitsa department second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India 
Phone  9503704923  
Fax    
Email  poojaak2021@gmail.com  
 
Source of Monetary or Material Support  
S G phytopharma Adress B-53/D-21,MIDC Gokul shorgaon, S G phytopharma pharmaceutical ltd Kolhapur 416237 
 
Primary Sponsor  
Name  Dr Pooja Ashok Khote  
Address  opd no 17 kayachikitsa department second floor Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala dist Kolhapur pincode 416114 country India 
Type of Sponsor  Other [ Self] 
 
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 Pooja Ashok Khote   Yashwant ayurvedic college post graduate training and research centre Kodoli   Opd no 17 department of Kayachikitsa second floor
Kolhapur
MAHARASHTRA 		 9503704923

poojaak2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Yashwant ayurvedic college PGT and RC kodoli   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Nasya (Procedure Reference: Charak sutrasthan5/57-59, Procedure details: Instill 2 drops of medicated oil in each nostril 2 times at morning & at evening per day for 3 months )
(1) Medicine Name: Anu tail, Reference: Charak chikitsa 20, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: bd, Duration: 3 Months
2Intervention ArmDrugClassical(1) Medicine Name: Yashtimadu churna , Reference: Charak sutrasthan25, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -godugdha ), Additional Information: -
3Comparator ArmProcedure-Nasya (Procedure Reference: Charak sutrasthan5/57-59, Procedure details: Instill 2 drops of medicated oil in each nostril 2 times at morning & at evening per day for 3 months)
(1) Medicine Name: Yashtimadu tail, Reference: Sharangadhar samahita 9/155, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: bd, Duration: 3 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  The patients of khalitya will be selected irrespective of occupation religion and prakriti
Patient who are fit for nasya karma procedure  
 
ExclusionCriteria 
Details  Patients who are contraindicated for nasya karma procedure
Patients having alopecia areata, alopecia totalis, tinea capitis, traction alopecia
Patients on chemotherapy
Patients of HIV and TB
Serious ill patient  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Yashtimadhu churna internalywith Anu tail nasya in khalitya vyadhi
To decrease the keshapatan
To decrease keshbhumi kandu
To decrease keshrukshata 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study etiopathogenesis of khalitya in ayurveda & modern literature
To study the growth of hair
To study the decrease in dryness of hair 		 1month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/05/2025 
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   My title is Randomised open controlled Clinical study to evaluate the efficacy of Yashtimadhu churna with Anu tail nasya in khalitya. Included the patients of classical signs and symptoms of khalitya keshapatan, keshbhumikandu,kesharukshata, visibility of scalp, hair pull test, no.of fallen hairs approximately. Treatment given Yashtimadhu churna 3gm twice a day internally for 3 months with Anu tail nasya 2 drops twice a day for 3 months to study the changes in sign and symptoms of khalitya vyadhi. 
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