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CTRI Number  CTRI/2022/04/042180 [Registered on: 26/04/2022] Trial Registered Prospectively
Last Modified On: 03/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Local Application Of Ayurvedic Hair oil Shiroabhyanga in the darunaka patients.]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Study of the Shiroabhyanga (Head Massage) of an ayurvedic Hair oil as compared with coconut oil in Darunaka (Dandruff). 
Scientific Title of Study   A Randomized Controlled Clinical Study of the Shiroabhyanga (Head Massage) of an ayurvedic Hair oil as compared with coconut oil in Darunaka (Dandruff). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Indrayani Sunil Shrigiriwar 
Designation  PG Student 
Affiliation  Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune 
Address  Department of Swasthavritta OPD No 7 Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  8999288873  
Fax    
Email  shrigiriwar.indrayani95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh B Shinde 
Designation  Associate Professor 
Affiliation  Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune 
Address  Department of Swasthavritta OPD No 7 Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  9028383505  
Fax    
Email  yogesh.ayurved@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Indrayani Sunil Shrigiriwar 
Designation  PG Student 
Affiliation  Dr D Y Patil college of Ayurveda and Research Centre Pimpri Pune 
Address  Department of Swasthavritta OPD No 7 Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  8999288873  
Fax    
Email  shrigiriwar.indrayani95@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Ayurveda and Research Centre Pimpri Pune 
 
Primary Sponsor  
Name  Dr Indrayani Sunil Shrigiriwar 
Address  Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 
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 Indrayani Sunil Shrigiriwar  Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune  Department Of Swasthavritta OPD No 7 Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA 
8999288873

shrigiriwar.indrayani95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-shiro abhyanga (Procedure Reference: Charak and Sushrut Samhita, Procedure details: )
2Intervention ArmProcedure-shiro abhyanga (Procedure Reference: charak samhita and sushrut samhita, Procedure details: 10 ml of formulated ayurvedic hair oil application on the scalp as a head massage daily for 28 days at night for about 3-5 minutes. )
(1) Medicine Name: Ayurvedic hair oil, Reference: Bhavprakash nighatu book, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 28 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients of age between 20 to 50 years.
2. Patients showing symptoms of Darunaka.
3. Patients willing to participate in the study.

 
 
ExclusionCriteria 
Details  1. Patients with other major Physical illness
viz. IHD, Malignancy etc.
2. People having genetic diseases.
3. Patients not willing to participate in the study.
4.The person suffering from other hair and scalp diseases.
5. Psoriasis of scalp , eczema of the scalp , head injury in which head bath/wash is restricted ,fungal infection ,Ringworm infestation to scalp , patients with severe hairfall like Indralupta .
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
An ayurvedic hair oil shiroabhyanga (head massage) is effective in the management of darunaka.   Day 0 -14 -28

Day 0
1.Ayurvedic parameters of darunaka based on symptoms
2. Tichoscopic image examination.
3. scalp health study.

Day 14th - first follow up
1.Ayurvedic parameters of darunaka based on symptoms

Day 28 - second and last follow up
1.Ayurvedic parameters of darunaka based on symptoms
2. Tichoscopic image examination.
3. scalp health study 
 
Secondary Outcome  
Outcome  TimePoints 
Formulated Ayurvedic Hair Oil Shiroabhyanga is effective in the other conditions like scalp health and hair fall rate and follicular strength  Day 0-14-28

Day 0
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope.

Day 14th - First follow up
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope.

Day 28th - second and last follow up
1.Scalp health trichoscopic examination
2.Hair pull test
3.60 second hair count test
4.Follicular strength study by trichoscope. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) 19/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Primary objective - To study the effectiveness of the ayurvedic hair oil shiroabhyanga (head massage) in the  darunaka.
Secondary objective - To observe the other healthy changes in the scalp and hair like Hair fall rate (if present)

Ayurvedic hair oil will be prepared from  total 10 keshya drugs which were given in the Bhawprakash Nighantu. The base of the oil will be black sesame oil. An oil will be prepared by the ancient ayurvedic technique of oil preparation known as Sneha pak vidhi with its given standard  proportion of 1:4:16.
Study will be in two groups 

Group A-  38 patients - Trial group- Ayurvedic hair oil 
Local application of formulated ayurvedic hair oil shiroabhyanga(head massage) , daily with 10 ml definate quantity , at night  for total 28 days .

Total enrollment number will be 38 + 38 = 76 . 

Group B - 38 patients - Control group - coconut oil
Local application of parachute coconut hair oil shiroabhyanga (head massage), daily with 10 mi definate quantity , at night for total 28 days.

Follow uo schedule - total two followups with intervals of 14 days.

 Duration  - 28 days 

Observation and Conclusion - will be drawn on the basis of proper statistical methods



 
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