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CTRI Number  CTRI/2022/05/042945 [Registered on: 31/05/2022] Trial Registered Prospectively
Last Modified On: 01/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of Yashtimadhu Taila Nasya in the management of premature graying of hair 
Scientific Title of Study   A clinical study to evaluate the efficacy of Yashtimadhu Taila Nasya in the management of Akal Palitya W.S.R. to Premature Graying of Hair  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamalpreet Kaur Virdi 
Designation  PG Scholar 
Affiliation  Dayanand Ayurvedic College and Hospital  
Address  Department of Panchakarma, Dayanand Ayurvedic College and Hospital

Jalandhar
PUNJAB
144008
India 
Phone  8146295450  
Fax    
Email  kamal.kpk05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parveen Kumar 
Designation  Associate Professor 
Affiliation  Dayanand Ayurvedic College and Hospital 
Address  Department of Panchakarma, Dayanand Ayurvedic College and Hospital

Jalandhar
PUNJAB
144008
India 
Phone  7589303536  
Fax    
Email  drparv1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parveen Kumar 
Designation  Associate Professor 
Affiliation  Dayanand Ayurvedic College and Hospital 
Address  Department of Panchakarma, Dayanand Ayurvedic College and Hospital

Jalandhar
PUNJAB
144008
India 
Phone  7589303536  
Fax    
Email  drparv1@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Ayurvedic College and Hospital, Jalandhar 
Dayanand Ayurvedic Pharmacy 
 
Primary Sponsor  
Name  Dr Kamalpreet Kaur Virdi 
Address  Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, opp. Burlton Park, Jalandhar, Punjab, 144008  
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 Parveen Kumar  Dayanand Ayurvedic Hospital  Department of Panchakarma
Jalandhar
PUNJAB 		 7589303536

drparv1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L671||Variations in hair color. Ayurveda Condition: AKALAPALITAH/PALITAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushrut Samhita Chikitsa Sthan 40/22, Procedure details: Nasya will be given to patient as mentioned in ayurvedic texts with proper poorav, pradhan and paschata karma for a total of 30 days. Patient will be followed up twice at the interval of 15 days i.e. 15 days after completion of nasya and second follow up after 15 days of first follow up)
(1) Medicine Name: YASHTIMADHU TAILAM, Reference: Cakardatta, Netra roga Chikitsa, Ch.59/189, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Patient aged between 15-35 years with premature graying of hair.
2. Patient fit for Nasya
3. Patient of either sex
4. Patient willing to participate in the study



 
 
ExclusionCriteria 
Details  1. Patients with any systemic disorder
2. Patients with any skin disease like albinism, leucoderma or vitiligo
3. Patients with hereditary disorder (Werner’s syndrome: diagnosis will be done on clinical grounds through thorough history of patient)
4. Patients with hormonal imbalance like hyperthyroid or hypothyroid
5. Patient with Megaloblastic Anemia
6. Any autoimmune disease
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assessed on following criteria and their respective scoring

1.Kesha varna(color of hair) Natural color of hair 0
Ash colored 1
Yellowish 2
White hair 3

2.Ruksha sphuttita kesha(dry split ends)
Normal 0
Visible dryness 1
Dryness felt by touch 2
Split ends 3

3.Sanighad sthula (unctuous thick hair)
Normal 0
Unctuous visible 1
Unctuous felt by touch 2
Unctuous felt with
split hair 3

4.Daha over scalp
(burning sensation)
No burning sensation 0
Mild burning sensation 1 (localized)
Moderate burning sensation 2
Severe burning sensation 3 (all over the scalp)


 		 Day 0: At the time of enrollment of patient for study
Day 30: At the end of treatment
Day 45: At first Follow up
Day 60: At second Follow up
 
 
Secondary Outcome  
Outcome  TimePoints 
Random hair count will be done for counting number of gray hair. Scalp will be divided into five regions i.e. Frontal, Vertex, Right and Left Temporal and Occipital. One square centimeter area of scalp will be chosen where more gray hair are present, from this site gray hair would be counted randomly before and after the treatment.
Scoring of gray hair will be as follows:
Number of gray hair Score
a) Less than 10% 0
b) 10-20% 1
c) 20-30% 2
d) 30-40% 3
e) 40-50% 4
f) 50-60% 5
g) 60-70% 6
h) 70-80% 7
i) 80-90% 8
j) 90% and above 9
 		 Day 0: At the time of enrollment of patient for study
Day 30: At the end of treatment
Day 45: At first Follow up
Day 60: At second Follow up
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/06/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The face of an individual is a personal identity in which hair play a significant role. Healthy hair is a healthy sign of personality and youth. Everyone wants to look younger than their age and first thing they do is to hide their gray hair either by dyeing or some other ways. There is always a solution to every problem, same applies to canities (gray hair). So there is need to find a solution to make these canities to revert back to normal hair or stop the process of premature graying of hair. Akal Palitya or premature graying of hair is a disease pertaining to head and Nasya has been mentioned effective in Shiroroga. The information about the concept of Nasyakarma in Panchakarma and its importance is mentioned very well in Ayurvedic Samhita Granthas.  In ayurveda nose is considered as the gateway of the head . The process of giving medication through nose is called Nasyakarma. It is considered as the best route of medication for the ailments pertaining to head. Acharya Sushrut, while mentioning the guna and importance of Nasya, has mentioned that Nasya is effective in Palitya rog in Sh.Ch. 40/22 . Acharya Cakardatta has mentioned Yashtimadhu Taila  in 59th chapter, Netrarog Chikitsa. It has been told that taking nasya of this taila for one month will make vision clear and make  wrinkles and gray hair disappear. Therefore Nasya is selected as route of administration for medication in Akal Palitya for clinical study. So this study will answer these questions of reversibility, stagnation of canities along with effectiveness of Nasya in Akal Palitya shall also be tested.

 

 
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