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CTRI Number  CTRI/2024/12/078122 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 17/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Treating dandruff with Hair pack using herbal medicine 
Scientific Title of Study   An observational clinical study to evaluate Upashayatmaka effect of Shivamrabijachurna Lepa in Darunaka vis-a-vis Pityriasis Capitis(Dandruff) 
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 Chanagoud Patil 
Designation  MD Scholar 
Affiliation  HASSs Ayurveda Mahavidyalaya and Hospital, Hubballi 
Address  OPD 4 Department of Roganidana evum Vikruti Vigyana Ayurveda Mahavidyalaya and HospitalHeggeri extension old Hubballi Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  8310109454  
Fax    
Email  chanagoudmp5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Y Thimmapur 
Designation  Professor and Head of the Department 
Affiliation  HASSs Ayurveda Mahavidyalaya and Hospital 
Address  Department of Roga Nidana evum Vikruti Vigyana Ayurveda Mahavidyalaya and HospitalHeggeri extension old Hubballi Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  9886054574  
Fax    
Email  drrajut@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Chanagoud Patil 
Designation  MD Scholar 
Affiliation  HASSs Ayurveda Mahavidyalaya and Hospital, Hubballi 
Address  OPD 4 Department of Roganidana evum Vikruti Vigyana Ayurveda Mahavidyalaya and HospitalHeggeri extension old Hubballi Hubballi

Dharwad
KARNATAKA
580024
India 
Phone  8310109454  
Fax    
Email  chanagoudmp5@gmail.com  
 
Source of Monetary or Material Support  
Ayurveda Mahavidyalaya and Hospital, Hubballi, Dharwad district, Karnataka, India 580024 
 
Primary Sponsor  
Name  Dr Chanagoud Patil 
Address  Department of Roganidana Ayurveda Mahavidyalaya and Hospital, Hubballi Karnataka 580024 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 Chanagoud Patil  Ayurveda Mahavidyalaya and Hospital  Room No:04, Department of Roganidana, Ayurveda Mahavidyalaya and Hospital, Heggeri extension, Old Hubli, Hubballi
Dharwad
KARNATAKA 		 8310109454
122
Chanagoudmp5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurveda Mahavidyalaya and Hospital Hubli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shivamrabeeja Churna, Reference: Sharangadhara Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Quantity sufficient churna was taken, mixed with luke warm milk and applied on scalp, left for 20 mins and washed off using water
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects presenting with signs and symptoms of Darunaka/Pityriasis Capitis over scalp
Subjects irrespective of gender, religion, occupation and socioeconomical status 
 
ExclusionCriteria 
Details  Subjects having Hypersensitivity and scalp disorders like scalp psoriasis, tinea capitis, trichotillomania, and traumatic alopecia, and other systemic scalp disorders
Psychological diseases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the scales over the scalp
Reduction in scalp itching, dryness 		 base line, 7th day, 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Hairfall  base line, 7th day and 15th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/12/2024 
Date of Study Completion (India) 25/05/2025 
Date of First Enrollment (Global)  30/12/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
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 - Proposals should be directed to [Chanagoudmp5@gmail.com].

  6. For how long will this data be available start date provided 30-11-2025 and end date provided 31-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Trial titled  An observational clinical study to evaluate Upashayatmaka effect of Shivamrabijachurna Lepa in Darunaka vis-a-vis Pityriasis Capitis(Dandruff), is a Non-randomized active control study which will be conducted on subjects fulfilling the subjective and objective criteria, Shivamrabijachurna lepa on scalp will be advised for 15 days, follow up will be taken on 7th and 15th day, and parameters will be assessed based on the grading before and after treatment. 
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