FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047115 [Registered on: 07/11/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the efficacy of Bibhitaki siddha tail shiroabhyanga in the management of Khalitya with special reference to Hairfall  
Scientific Title of Study   Randomized clinical trial to study the efficacy of Bibhitaki Siddha Tail Shiroabhyanga in the management of Khalitya with special reference to hairfall.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghavi Suresh Gharde 
Designation  Pg Scholar 
Affiliation  Vidarbha Ayurved Mahavidyalaya Amravati 
Address  OPD NO-12 Department of Swasthavritta and Yoga Vidarbha Ayurved Mahavidyalaya Chhatri Talao road near farshi stop Amravati

Amravati
MAHARASHTRA
444601
India 
Phone  9545483161  
Fax    
Email  meghavisurgharde03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay K Chopkar 
Designation  Guide and HOD Department of Swasthavritta and yoga 
Affiliation  Vidarbha Ayurved Mahavidyalaya Amravati 
Address  Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati
vidharbh ayurved mahavidyalaya amravati dastur nagar farshi stop
Amravati
MAHARASHTRA
444601
India 
Phone  9423105104  
Fax    
Email  skchopkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meghavi Suresh Gharde  
Designation  Pg Scholar 
Affiliation  Vidarbha Ayurved Mahavidyalaya Amravati 
Address  Vidarbha Ayurved Mahavidyalaya Chhatri talao road near farshi stop Amravati
vidharbh ayurved mahavidyalaya amravati dastur nagar farshi stop
Amravati
MAHARASHTRA
444601
India 
Phone  9545483161  
Fax    
Email  meghavisurgharde03@gmail.com  
 
Source of Monetary or Material Support  
Vidarbha Ayurved Mahavidyalaya Amravati 
 
Primary Sponsor  
Name  Vidarbha Ayurved Mahavidyalaya Amravati 
Address  chhatri talao road near farshi stop Amravati 
Type of Sponsor  Research institution and hospital 
 
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 
Meghavi Suresh Gharde  Vidarbha Ayurved Mahavidyalaya and Hospital Amravati  OPD no 12 Department of swasthavritta and yoga Vidarbha Ayurved Mahavidyalaya and Hospital chhatri talao road near farshi stop Amravati
Amravati
MAHARASHTRA 		 9545483161

meghavisurgharde03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S H V P M Vidarbha Ayurved Mahavidyalaya Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KHALITYAM/KHALATI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-. Siro~aBya~ggaH िशरोरऽ"ंग (Procedure Reference: Ashatang Hrudya, Procedure details: Purvakarma- The patient was made to sit on knee high chair, the body of the patient was wrapped by cloth. The procedure was followed by standing behind the patient. Pradhan karma- The technique included smearing of oil to the scalp above the neck with specific strokes were placed. Gharshan Hasta- After smearing the oil massages the whole head and the neck moving the palmar surface of the hand from front to backwards applying gentle pressure. Mridvanguli Tadana- Fingers of the both hands moved .)
(1) Medicine Name: Bibhitaki siddha taila, Reference: Bhavprakash, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 120 Days
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Hair care counselling and coconut oil for daily application, Pathya/Apathya:yes, Pathya: Aahar-Madhur ras pradhan aahar Vihar-Combing of hairs, Shiroabhyanga, Bath, Ushnivdharan, Apathya:Aahar- Amla and Lavan ras pradhan aahar, Kshara Vihar- Vegadharan, Ratrijagaran,Diwaswap,Atiushnajalshirsnana
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Subject having sign and symptoms of Khalitya
2 Subject ready to give informed conset 
 
ExclusionCriteria 
Details  1 Subject having history of any other general systemic illness
2 Subject taking any other treatment for same complaint at the same time
3 Subject having alopecia arreta alopecia totalis Traction alopecia Alopecia due to systemic disease
4 Patient suffering from Malignancy
5 ANC and PNC  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
75-100% Relief in sign and symptoms- Cured
More than 50% relief in sign and symptoms- Markedly cured
25to30% Relief in sign and symptoms - Improved
 		 0th day
15th day
30th day
45th day
60th day
75th day
105th day
120th day 
 
Secondary Outcome  
Outcome  TimePoints 
Remission in symptoms of Darunaka
Remission in symptoms of Kesharukshata
Remission in symptoms of Keshakathinya
Improvement in sleep pattern
Improvement in eyestrain
Relief in mental stress 		 0th day
45th day
90th day
120th day 
 
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 2/ Phase 3 
Date of First Enrollment (India)   10/11/2022 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A Randomized clinical trial will be conducted to study the effect of Bibhitaki siddha tail Shiroabhyanga in the management of Khalitya with special reference to Hairfall. Trial will be conducted in our institute.Total 120 patients with inclusive criteria having sign and symptoms of Khalitya will be selected and divided into two groups.One group will be advised Bibhitaki siddha tail Shiroabhyanga and other group will be advised Hair care counselling and application of plain coconut oil. Obsevation will be done and Result will be compared. Primary outcome will be about effect  of Bibhitaki siddha tail Shiroabhyanga and Secondary outcome will be about assessment criteria of effect of therapy.And result will be noted. 
Close