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CTRI Number  CTRI/2025/04/085558 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Other (Specify) [external theraphy through nostril]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   one taila name Prapaundarikadi taila mentioned in Ayurveda Classic to see effect in Hairfall. The Population taken are normal healthy people having hairloss because due to Life style reasons. Assessement include some question and one image of head scalp to see any growth 
Scientific Title of Study   To assess the effect of Prapaundarikadi taila nasya in the management of Khalitya- Acontrolled Clinical study  
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 Shreekala PV 
Designation  pg scholar,Dept of Swasthavritta and Yoga 
Affiliation  KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi 
Address  OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi
OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  08157940284  
Fax    
Email  shreekala97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev S Tonni 
Designation  professor, dept of swasthavritta and yoga 
Affiliation  KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi 
Address  OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi
OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  9448543858  
Fax    
Email  sanjeevtonni@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjeev S Tonni 
Designation  professor, dept of swasthavritta and yoga 
Affiliation  KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi 
Address  OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi
OPD 2, Department of Swasthavritta and Yoga KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi

KARNATAKA
590003
India 
Phone  9448543858  
Fax    
Email  sanjeevtonni@yahoo.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research Center,JNMC NEHRU NAGAR, BELAGAVI, KARNATAKA, 590010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research Center 
Address  KLE Academy of Higher Education and Research Center,JNMC NEHRU NAGAR, BELAGAVI, KARNATAKA, 590010 
Type of Sponsor  Other [Deemed to be University] 
 
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 Shreekala PV  Shri BM Kankanawady Hospital  OPD2, Dept of Swasthavritta and Yoga,KLE Shri BMK Ayurveda Mahavidyalaya, Belagavi, 590003
Belgaum
KARNATAKA 
08157940284

shreekala97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHERs Shri BMK Ayurveda College, Institutional ethical Commitee For Research in Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: shatbindu taila, Reference: bhaishajya ratnavali shiroroga adhikara shloka 49-51, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -it is taila given as nasya for 14 days as a prathimarsha that is 2 drops
2Intervention ArmDrugClassical(1) Medicine Name: Prapaundarikadi taila, Reference: Ashtanga Hridya Uttarastana Shiroroga Adhikara, 44 shloka, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -it is taila nasya given 2 drops daily till 14 days as a prathimarsha nasya
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  individual of both sexes ranging from 16 years to 60 years. individual with symptoms of itchy scalp, hairfall, keeshabhoomi daha, burning and dryness of scalp 
 
ExclusionCriteria 
Details  individual less than 16 years and above 60 years, no history of hair loss due to surgery, hereditary, systemic disorder 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Prapaundarikadi Thailam Nasya in the management of ‘Khalitya’   10 months  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Prapaundarikadi Thailam Nasya with Shadbindu Tailanasya in
the management of ‘Khalitya’ (Hair fall). 
18 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 4 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Review of literature 
Khalitya is mentions in several ancient Ayurvedic texts. It has been included in Shiroroga by 
Acharya Charaka and Ashtanga Hridayakar, indicating its classification within diseases of the 
head and scalp. This classification is based on the location of the disease and its 
etiopathogenesis. 
According to Ashtanghridaya, nine diseases occurring on the outer part of the head over the scalp 
are categorized as shiroroga, among which Khalitya finds its place. Additionally, other classical 
Ayurvedic texts such as Sushrut Samhita, Ashtangasamgrah, Yoga Ratnakar, and Madhav Nidan 
have also included Khalitya under kshudra roga, or minor diseases. 
This categorization in kshudra roga is attributed to the mildness of Khalitya compared to other 
major diseases. While Khalitya may not pose life-threatening risks, its impact on physical 
appearance and mental well-being can still be significant, underscoring the importance of 
understanding and addressing this condition within the broader context of Ayurvedic medicine. 
Khalitya, according to Ayurveda, is primarily considered a Pitta-dominant Tridoshjanya Vyadhi. 
This classification suggests that it involves an imbalance of all three doshas—Vata, Pitta, and 
Kapha—along with the involvement of Rakta dosha. 
In this context, vitiated Pitta, specifically Bhrajaka Pitta, plays a significant role. When it 
becomes aggravated or imbalanced, it can lead to weakening of the hair from the roots. This 
weakening can result in hair fall and other related issues. 
Additionally, the involvement of vitiated Vata worsens the condition by further weakening the 
hair roots. Vata dosha, when imbalanced, is known to disrupt the natural stability and 
nourishment of the hair follicles, making them more susceptible to damage and loss. 
Moreover, vitiated Kapha, along with Rakta dosha, contributes to Khalitya by obstructing the 
hair roots (Romakupa). Kapha dosha, when deranged, can lead to excessive buildup and 
congestion, which may impede the nourishment and growth of hair follicles. Rakta dosha, which 
represents the blood and its components, can exacerbate this obstruction by causing stagnation or 
blockages in the microcirculation around the hair roots.Prapaundarikadi taila is mentioned by 
Ashtanga hridya as prathimarsha nasya for shiroroga. The ingerdients of this taila having 
properties of Tridosha hara,balya,cakshushya and having rasayana properties.This study aims to 
evaluate the effect of i Prapaundarikadi taila nasya in khalitya 

 
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