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CTRI Number  CTRI/2022/10/046699 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy of Dhurdhurapatradi hair oil with or without Amrabeej and Haritaki Churna head aplication(shirolepa) in the treatment of Dandruff. 
Scientific Title of Study   A Randomized comparative study to compare the efficacy of Dhurdhurapatradi Tailam Shiroabhyanga with or without Amrabeej and Haritaki churna Shirolepa in the treatment of Darunaka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
no  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakhi Mithun Maniyar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre Nigadi Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor, Shalakya department Sector no. 25 Nigdi Pradhikaran, Pune. MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9309599428  
Fax    
Email  rkhmaniyar70@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manisha Pravin Pingale 
Designation  Associate professor 
Affiliation  PDEAs College of Ayurved and Research Centre Nigadi Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor, Shalakya department Sector no. 25 Nigdi Pradhikaran, Pune. MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9028360353  
Fax    
Email  manishapingale.mp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakhi Mithun Maniyar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre Nigadi Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor, Shalakya department Sector no. 25 Nigdi Pradhikaran, Pune. MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9309599428  
Fax    
Email  rkhmaniyar70@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre, sec.no.25 Pradhikaran Nigdi Pune 411044  
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research centre Nigadi Pune 
Address  PDEAs College of Ayurved and Research centre sec.no.25 Pradhikaran Nigdi Pune 411044 
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 Rakhi Mithun Maniyar  Ayurved Rugnalay and Sterling multispeciality Hospital, Nigdi pradhikaran Pune  Vitthal Rukmini road, sector no 27, Shalakya OPD no 122 ,Nigdi Pradhikaran Pune 411044 MAHARASHTRATRA
Pune
MAHARASHTRA 		 9309599428

rkhmaniyar70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male female with moderate to Severe dandruff 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Charak sutrasthan , Procedure details: Siroabhyanga daily in the morning for 21 days with 3 follow up (7th,14th and 21st day))
(1) Medicine Name: Dhurdhurpatradi tailam, Reference: Yogratnakar, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days
2Intervention ArmProcedure-lepaH (viShopakramaH), लेपः (विषोपक्रमः) (Procedure Reference: Sushrut samhita sutrasthana, Procedure details: Shirolepa in morning after semidry it will be washed with water daily for 21 days)
(1) Medicine Name: Amarbeej and Haritaki churna, Reference: Sahastra yoga, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are having three or more following signs and symptoms
1.Itching in scalp
2.Hair-fall due to dandruff
3.Dryness in scalp
4.Dandruff in scalp
5.Cracking of scalp skin 
 
ExclusionCriteria 
Details  1. Alopecia areata
2. Seborrheic dermatitis
3. Scalp Psoriasis
4. Contact Eczema
5. Patient not fit for Abhyanga
6. Pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
-To identify the difference of treatments for the management of dandruff.
-To compare the effectiveness of treatments over the period of time.
-To compare the Efficacy of
Dhurdhurapatradi Tailam Shiroabhyanga with or without Amrabeej and
Haritaki Churna Shirolepa in the Management of Darunaka. 		 Total 21 days treatment.
Baseline (0 Day), 7th Day, 14th day and 21 day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the efficacy of Amrabeej and Haritaki churna shirolep
2.To assess the efficacy of Dhurdhurpatradi tailam Shiroabyanga
3.To find the effect on hair fall.
4.To assess the adverse effect of treatment, if any
 		 21 days treatment with 3 follow up 7th,14th,21st day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/10/2022 
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 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
    Response -  Analytic Code

  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 [rkhmaniyar70@gmail.com].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 31-12-2028?
    Response (Others) -  As per journal requirement

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a randomised comparative study to compare the efficacy of Dhurdhraptradi Tailam shiroabhyanga with or without Amrabeej and Haritaki churna shirolepa in treatment of Darunaka. Darunaka  is a skin disease which affect the scalp.It is amongst the nine types of Kapalgata rogas in shirorogas explained in samhitas like Ashtang sangrahas Ashtang Hrudayas. Generally as per literature about 50% human were exposed ,being at puberty showed peak occurrence  and harshness at 20 years of age and not found frequently after 50 years of age.The aim of treatment to controlling Darunaka (dandruff )and prevent hair fall.In the present Dhurdhurpatradi tailam shiroabhyanga daily with or without Amrabeej and Haritaki churna shirolepa with dugdha on alternate days in the management of Darunaka.The  Dhurdhraptradi tailam sheroabhanga reference came in Sahastra yoga literature. The Amrabeej and Haritaki churna shirolepa  reference taken from Ayurvedic samhitas like yogratnakar,sharangdhar samhitas. Dhurdhupatradi tailam is well known for anti dandruff activity and Amrabeej and Haritaki churnas  with dugdha mentioned in shlokas for treatment of Darunaka. Hence it is propose to evaluate the efficacy of Amrabeej and Haritaki churnas shirolepa with dugdhain contrast to Dhurdhurpatradi tailam  shiroabhyanga in darunaka (dandruff). 
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