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CTRI Number  CTRI/2021/07/035015 [Registered on: 20/07/2021] Trial Registered Prospectively
Last Modified On: 12/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Nasya]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Nasya Therapy in Premature Graying of Hair 
Scientific Title of Study   Study to evaluate the efficacy of Vibhitaka Majja Taila Nasya in Premature Graying of Hair (Akaala Palitya) 
Trial Acronym  pavan 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reshma Shekh 
Designation  MD Scholar, Swasthavritta Department 
Affiliation  Pt. Khushilal Sharma Govt. Ayurveda College, Bhopal 
Address  Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Science Hills Behind MANIT Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone    
Fax    
Email  reshmashekh93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Reshma Shekh 
Designation  MD Scholar, Swasthavritta Department 
Affiliation  Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal 
Address  Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Science Hills Behind MANIT Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone    
Fax    
Email  reshmashekh93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Reshma Shekh 
Designation  MD Scholar, Swasthavritta Department 
Affiliation  Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal 
Address  Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Science Hills Behind MANIT Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone    
Fax    
Email  reshmashekh93@gmail.com  
 
Source of Monetary or Material Support  
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt Autonomous Ayurveda College Institute 
Address  Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute 
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 
Dr Nitin Marwaha  Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal  OPD No 8, Department of Swasthavritta, Pt. Khushilal Sharma Govt. Ayurveda College & Institute, Bhopal
Bhopal
MADHYA PRADESH 
9425377177

marwahaayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal (M.P)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E538||Deficiency of other specified B group vitamins. Ayurveda Condition: AKALAPALITAH/PALITAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline Water Nasya  2-2 drops of Normal Saline Water Nasya twice a day preferably in morning and evening time 
Intervention  Vibhitaka Majja Taila Nasya [Pratimarsha Nasya]  2-2 drops of Vibhitaka Majja Taila Nasya [Pratimarsha Nasya] twice in a day preferably in morning and evening time 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients who has not used hair dye / mehndi for last 6 months.
Patients who are willing to sign the written consent form.  
 
ExclusionCriteria 
Details  Patients with age below 15 years and, above 25 years.
Patients with pernicious anemia and any other autoimmune disease.
Known cases of hormonal , hepatic and renal disorder.
Patients on chemotherapy.
Patients using dyes and mehndi regularly.
Pregnant and Lactating women.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
20% of grey hair changes to natural color  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Marked improvement in grey hairs  3 months 
 
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 
Date of First Enrollment (India)   26/07/2021 
Date of Study Completion (India) 31/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/02/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Ø  In present study Randomly selected 40 patients of Akaal Palitya were allocated into two group (20 patients in each group).As group A ( Experimental ) and (Group B) . Total duration of study was 90 days.

Ø  In A Group, Vibhitaka majja taila nasya  had  administer 2-2 Drops of each nostril [Pratimarsha Nasya] twice a day preferably in the morning and evening time. In  group B,  Normal saline water had administered in the dose of 2-2 drop of each nostril twice a day preferably in the morning and evening time.

Ø  Out of registered 40 patients of Akaal Palitya all 40 patients completed the study.

Ø  In Group “A” (20 patients) who were treated with Vibhitaka Majja Taila Nasya had shown significant improvement in all subjective parameters (clinical symptoms) like colour of Hair,dry spllited hair,burning on scalp and objective parameters like GSS score, Serum Ferritine.

Ø  In Group “B” patients (20 patients) who were advised Normal saline water nasya have shown the insignificant improvement in all subjective parameters  as well as objective parameters.

Ø   On inter group comparison, Group A patients had shown the better improvement than Group B in all subjective and objective parameters.

Ø  The overall effect, in Group A, 1 (5%) patients showed moderate improvement while (10%) shows mild improvement, 17(85%) patients showed unchanged

Ø  result, whereas none(0%)of patients showed marked improvement.

Ø  In Group B, 1(5%) patients showed mild improvement, 19 (90%) patients showed unchanged result and none (0%) of patients showed moderate improvement and marked improvement.

Ø  From the above observation it is obvious that Vibhitaka Majja Taila Nasya provided better relief in all parameters as compare to Group B.

 
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