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CTRI Number  CTRI/2025/03/082218 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 23/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of khaskhas beej lepa in dandruff. 
Scientific Title of Study   Randomised controlled clinical study to evaluate the efficacy of dried seeds of ahiphen papaver somniferum linn in the management of Darunaka. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VINOD BALKRUSHNA BHOIR 
Designation  PG SCHOLAR 
Affiliation  Dr.G.D.Pol foundations Y.M.T. Ayurvedic Medical College Kharghar  
Address  Room no.211 second floor Dr.G.D.Pol Founadtions YMT Ayurvedic Medical College, Institutional area,Sector 4,Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  07887645378  
Fax    
Email  vinodbhoirayurved@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrDipti Kadam 
Designation  Associate Professor 
Affiliation  Dr.G.D.Pol foundations Y.M.T. Ayurvedic Medical College Kharghar  
Address  Room no.211 second floor Dr.G.D.Pol Founadtions YMT Ayurvedic Medical College, Institutional area,Sector 4,Kharghar, Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  9773794332  
Fax    
Email  drdiptimore@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DrDipti Kadam 
Designation  Associate Professor 
Affiliation  Dr.G.D.Pol foundations Y.M.T. Ayurvedic Medical College Kharghar  
Address  Room no.211 second floor Dr.G.D.Pol Founadtions YMT Ayurvedic Medical College, Institutional area,Sector 4,Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9773794332  
Fax    
Email  drdiptimore@yahoo.co.in  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Vinod Bhoir 
Address  2nd floor Department of Dravyaguna Vigyan room no 2 Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital P G Institute Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India 410210 
Type of Sponsor  Private medical college 
 
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 Vinod Bhoir  YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL KHARGHAR  2nd floor dravyaguna department room no. 2 YMT Ayurvedic medical college and hospital Institutional area sector4 kharghar navi mumbai 410210
Raigarh
MAHARASHTRA 		 07887645378

vinodbhoirayurved@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Y.M.T. AYURVEDIC MEDICAL COLLEGE ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L308||Other specified dermatitis. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Ketoconazole one percent shampooketoconazole one percent shampoo is used for hair wash once in a week
2Intervention ArmDrugClassical(1) Medicine Name: Ahiphen beej, Reference: Sharangdhar samhita chapter 11 shloka number 19, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: local application in the form of lepa,the paste is made up from soaking the ahiphen beeja in godugdh for half hour then apply over scalp region.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group from 18years to 50 years irrespective of gender.
Complaints of dandruff.
No any medical comorbodities.

 
 
ExclusionCriteria 
Details  Patient having other skin diseases such as psoriasis,eczema,tinea.
Patient with other medical comorbidities such as DM HTN.
patient who develops hypersensitivity reaction to given drugs in skin sensitivity test. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Dried seeds of ahiphen is effective in the management of darunaka.  Baseline,7days,14days,21days,28days 
 
Secondary Outcome  
Outcome  TimePoints 
Standardization of ahiphen seeds  Baseline,7days,14days,21days,28days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3/ Phase 4 
Date of First Enrollment (India)   19/03/2025 
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="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   Increasing trend of use of chemical based cosmetics like antidandruff shampoo resulting in various hair disorders,the synthetic chemical drug are very effective but long term use shows resistance and side effects.
there  are so many polyherbal preparations used in dandruff for local application.in sharangdhar samhita there is one reference for darunaka treatment in the form of lepa. so we are doing our study with regarding this reference for dandruff i.e. lepa ahiphen beeja lepa prepared by ahiphena beeja and milk for local application. in this study we are taking comparative arm as ketoconazole 1% shampoo for dandruff. 
In this study we are applying our sample for twice in a week for 4weeks with 7days intervals of followup.skin sensitivity test should be carried out befire application to scalp.
Standardisation of given drug should be done before study.
 
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