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CTRI Number  CTRI/2025/04/084651 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   It is a study to see how much effective is Ayurvedic Medicine Lakshadi guggulu and NIlikadi taila if disease Akala palitya with special reference to early age Graying of hairs  
Scientific Title of Study   Single arm clinical study to assess the efficacy of Lakshadi Guggulu and Nilikadi taila in the management of Akala Palitya with special reference to early age Graying of hairs  
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 Pravin Somnath Khedkar  
Designation  PG Scholar  
Affiliation  LRP Ayurvedic medical college and hospital, PG institute and Research center, uran islampur  
Address  LRP Ayurvedic medical college and hospital ,PG institute and Research center, kaumarbhritya deparment, OPD2, uran islampur

Sangli
MAHARASHTRA
415409
India 
Phone  9511928090  
Fax    
Email  khedkarpravin222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr jyotsna Ahir  
Designation  Professor 
Affiliation  LRP Ayurvedic medical college and hospital, PG institute and Research center, uran islampur 
Address  LRP Ayurvedic medical college and hospital ,PG institute and Research center, kaumarbhritya deparment, OPD2, uran islampur

Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr jyotsna Ahir  
Designation  Professor 
Affiliation  LRP Ayurvedic medical college and hospital, PG institute and Research center, uran islampur 
Address  LRP Ayurvedic medical college and hospital ,PG institute and Research center, kaumarbhritya deparment, OPD2, uran islampur

Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic medical college and hospital ,PG institute and Research center, kaumarbhritya deparment,OPD2,islampur taq. walava dist.sangli state. Maharashtra country India pin code.415409 
 
Primary Sponsor  
Name  Dr Pravin Somnath Khedkar  
Address  LRP Ayurvedic medical college and hospital ,PG institute and Research center, kaumarbhritya deparment, OPD2, uran islampur  
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 Jyotsna Ahir   LRP Ayurvedic medical hospital and research center uran islampur.  Kaumarbhritya department OPD number2.Balrugna division.room number 2
Sangli
MAHARASHTRA 		 9511928090

drjyotsnaahir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- LRP Ayurvedic medical college and hospital ,PG institute and Research center, uran islampur   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: AKALAPALITAH/PALITAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Lakshadi guggulu and Nilikadi taila , Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -oral drug lakshadi guggulu and topical Nilikadi taila
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Patient with the complaint of early age graying of hairs. 2. Patients irrespective of sex, age and socio-economic status willing to give concent for study. 3. Patients with mild anemia and normal. 
 
ExclusionCriteria 
Details  1.Patients with known case of genetic disease like albinsim and in born error of metabolism.2. Patients with malnutrition like marasmus and kwashiorkar. 3. Immunocompromised patients like HIV etc and steroid dependent patinets.4. Patinets with moderate and severe anemia  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
How much percentage of lakshadi guggulu and nilikadi taila are effective in the management of Akala palitya with special referance to early age gray hairs in children?  90 Days  
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the akalapalitya in ayurveda view. 2. To studya lakshadi guggulu in detail.3. To study nilikaditaila in detail.4. To study the early age graying of hair in modern view   90 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   12/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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  
  • Aim To study the effect of lakshadi guggulu and nilikadi taila in the management of akala palitya with special reference to early age gray hairs in children.
  • Primary Objective To study the effect of lakshadi guggulu and nilikadi taila in the management of akala palitya with special reference to early age gray hairs in children.
  • Secondary Objective 1To study the akala palitya in ayurveda view.  2 To study the lakshadi guggulu in detail. 3 To study nilikadi taila in detail. 4 To study the early age graying of hair in modern view.
  • Type of Study Design  Single Arm Clinical Study.
  • Study Settings All the clinical studies will be carried at our Ayurveda hospital OPD with Age group between 6 to 16 year and Pathological investigation.
  • Study Population Patients having Sign and symptoms of Akala Palitya of age group 6 to 16 year and inclusion criteria .
  • Study Duration  1 Duration of entire study- 18 months. 2 Duration of treatment - 90 days
  • Follow up  Follow up on 10th  30th 60th and 90th day
  • Diagnostic Criterion Patients will be diagnosed on the basis of clinical sign and symptoms of early age graying of hairs with respective grading 
  • Assessment Criteria a Subjective Criteria 1 Color of hair. 2 Structure of hair.   b Objective Criteria 1 Numbers of grey hairs. 2 Site of gray hair patch on scalp. 3 Blood investigation.
  • Observation and Results The observed Clinical Efficacy of treatment will be observed and recorded. 
  • Discussion Results will have discussed on the basis of collected data and statistical analysis.
  • Conclusion  It will be drawn strictly on the basis of statistical analysis. 
  • Summary  The research study will be summarized in brief. 
  • Ethical Consideration  The study will be conducted in accordance with ethical guidelines and informed consent from participant.
 
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