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CTRI Number  CTRI/2025/03/083019 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Management of palitya (pre mature greying of hairs) through prapaundrikadi tail.  
Scientific Title of Study   Clinical Study of Prapaundrikadi Tail in Palitya Roga W.S.R.to Pre-Mature Greying of Hair . 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dimple Patidar 
Designation  MD Scholar 
Affiliation  Govt Ayurveda College and Hospital Nipaniya Rewa  
Address  Department of Samhita Siddhant Government Ayurveda College and hospital Nipaniya Rewa M.P

Rewa
MADHYA PRADESH
486001
India 
Phone  9685832025  
Fax    
Email  dimplepatidar4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S N Tiwari 
Designation  Asssociate Professor 
Affiliation  Govt Ayurveda College and Hospital Nipaniya Rewa  
Address  Department of Samhita Siddhant Government Ayurveda College and hospital Nipaniya Rewa M.P Rewa Madhya Pradesh 486001 India

Rewa
MADHYA PRADESH
486001
India 
Phone  7581808285  
Fax    
Email  drsntiwari9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr pulsi pande 
Designation  Assistant Professor 
Affiliation  Govt Ayurveda College and Hospital Nipaniya Rewa  
Address  Department.of Samhita Siddhant Government.Ayurveda College and hospital Nipaniya Rewa M.P Rewa Madhya Pradesh 486001 India

Rewa
MADHYA PRADESH
486001
India 
Phone  9407042834  
Fax    
Email  pulsirewa@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Nipaniya Rewa 486001 Madhya Pradesh India  
 
Primary Sponsor  
Name  Govt ayurveda College Nipaniya Rewa  
Address  Department of Samhita Siddhant Government Ayurveda College and hospital Nipaniya Rewa 486001 Madhya Pradesh 
Type of Sponsor  Government 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 Dimple Patidar  Government Ayurveda College & Hospital, Rewa (M.P.)  Dept.of Samhita Siddhant Vibhag Govt.ayurveda college nipaniya rewa m.p Rewa MADHYA PRADESH 486001 India
Rewa
MADHYA PRADESH 
9685832025

dimplepatidar4@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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KESAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Prapaundrikadi Tail, Reference: ch.chi.26/277 , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.patient presenting with classical sign and symptom of palitya.2.Patirnt willing to sign the consent from.3.Patient fit for nasya karma. 
 
ExclusionCriteria 
Details  1.pragenant women and lactating mother.
2.Hereditary palitya disease.
3. Hormonal disease like thyroid disorder. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement In Subjective Parameters Like Kesha Varna Rooksha Sphutita Snigdha Sthoola Daaha  0 to 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assesse the effect of trial drugs in improving the sign ,symptoms as per assessment criteria  After 30 days  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3/ Phase 4 
Date of First Enrollment (India)   25/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Title - 
 CLINICAL STUDY OF PRAPAUNDRIKADI TAIL IN PALITYA ROGA W.S.R. TO PRE-MATURE GREYING OF HAIR.

Aim-
To Evaluate the efficacy of Charakokta Prapaundrikadi Tail in treatment of Palitya roga.

Objectives-

 1. To identify the probable mode of action of Prapaundrikadi tail in treatment of Palitya roga.
 2. To assess the efficacy of Prapaundrikadi tail in improving the signs and symptoms of Palitya roga.

Introduction-

 à¥‹à¤§à¤¶à¥‹à¤•मकतः शररोमा शरोगतः | प च कशान पचत प लतं तेन जायते || (Su.Ni.13/36)

  Ushma (Body heat) generated by anger, grief and fatigue, reaches head region and vitiated pitta changes the hair color and this has been described as Palitya.

  According to modern science factor affecting palitya are: 
Stress  
Improper dietry habits. 
Not following healthy life style & packaged food etc.
.
Modern review-
  Pre – mature greying of hair in ayurveda it is correlated with palitya under the heading of kshudraroga (minor disease) in Brihatrayi and laghutrayi. 

 Skin and hair color have been at the center of attraction in humans since ancient times.

 Greying of hair has major psychosocial & socioeconomic progressing old age, ill health bodily decline especially in today’s world where humans are confronted with increasing pressure to stay “forever young & vital” .

 It is a burning problem as larger percent of population especially young men & women in present time.
 
  The prevalence of premature graying of hairs (PMGHs) was found to be 27.3%. Binary logistic regression analysis showed that a paternal history of PMGH, history of smoking, maternal history of PMGH, sunlight exposure, and body mass index were significant predictors of PMGH.
  
The color of human hair depends on melanogenesis, through a process of synthesis of melanin and its subsequent distribution from the melanocyte to keratinocyte.

  The human hair follicles contain two types of melanin: -the black brown pigment eumelanins mainly present in black and brown hair.
 The yellow or red pheomelanins in red and blonde hair.

Need of research-
 In the present era of hush and rush due to improper diet and mental disturbance have led to increased prevalence of hair related problem, like greying of hair.

Now a days pre mature greying of hair affects cosmetic concern of person.
 
  Patients are often seen in dealing with mental and social problems regarding to with self-esteem, self-confidence, social withdrawal, depression etc due to palitya.

  This research will be helpful in treatment and prevention of palitya. 

  And also helpful in relieving of mental stress and in prevention of further stage. 

  In modern science, there is only local application like dye and symptomatic treatment, so this will be providing removal of root of disease.

 Study design-
Study type-  Interventional
Purpose- Treatment 
Masking -Open labelled, Clinical trial 
Direction -Prospective
End Point- Efficacy
No of groups -Single group
Sample Size- 50 patient

PROBABLE MODE OF ACTION OF PRAPAUNDRIKADI TAILA-

  Almost all of these Dravya have sheeta virya,keshya and pitta shamaka property by which the effect of the prapaundrikadi tail on palitya is considerable.
 
  Prapaundrik taila has snigdha,laghu,sheeta and Sukshma properties.Snigdha guna composed of prathvi and apya mahabhut .charaka said that kesha is Parthivbhava predominant ,so snigdha guna increase kesha because of samanya vishesh Siddhant

.  Sheeta guna act on pitta dosha,which is main causative factor of palitya.The obstruction of srotas is clear by the Sukshma guna ,which affects the varna Utpatti.
 
 Prapaundrik contains tannis, sponins and nymphayol which helps in giving colour to the hair.

  Raktachandan contains pigment santalin (santalic acid), Which acts as dye giving colour to the hair.

  Pippali has piperine which act anti-oxidant, anti-apoptotic and restorative ability against cell damage.

 Also, the antioxidants present in amalaki helps in reducing canities (greying of hair)
.
Treatment regimen-

  Drug: - Prapaundrikadi tail 
  Mode of administration: - pratimarsh Nasya 
  Dose: - 4 drops of prapaundrikadi tail in each nostril (2-2 Drops)
  3 courses of nasya: - Each course of 7 days with 3 days of rest between each course.
  Time of administration: - pratah kaal (Morning on Empty Stomach) 
  Duration: - 30 Days 
  Follow up: - 6 months 
 Diet: - Patient advice to avoid stress, excessive grief, anger and pitta vaardhak aahar.
 

 

 
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