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CTRI Number  CTRI/2024/10/075962 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To improve skin colour by Shatavari. 
Scientific Title of Study   Assessment of Varnya Karma (Complexion enhancer) of Shatavari in individual with skin phototype 3 to 5 on Fitzpatrick scale -A randomized clinical study. 
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 Anjali Shantaram Patil 
Designation  PG scholar 
Affiliation  Govt Ayurvedic Medical College 
Address  Department of Dravyagun vigyan Shri Narayan Prasad Awasthi Government Ayurvedic College RAIPUR, CG.

Raipur
CHHATTISGARH
492001
India 
Phone  9172478060  
Fax    
Email  anjalipatil7890@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin Kumar Joshi 
Designation  HOD & PROFESSOR in Department of Dravyagun vigyan 
Affiliation  Govt Ayurvedic Medical College 
Address  Department of Dravyagun vigyan Shri Narayan Prasad Awasthi Government Ayurvedic College RAIPUR, CG.

Raipur
CHHATTISGARH
492001
India 
Phone  9407649488  
Fax    
Email  pravinkumarjoshi7000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Singh 
Designation  Lecturer in Department of Dravyagun vigyan 
Affiliation  Govt Ayurvedic Medical College 
Address  Department of Dravyagun vigyan Shri Narayan Prasad Awasthi Government Ayurvedic College RAIPUR, CG.

Raipur
CHHATTISGARH
492001
India 
Phone  9827085023  
Fax    
Email  vdrajeshsingh12@gmail.com  
 
Source of Monetary or Material Support  
Special Clinic 1 of Dravyagun Vigyan Shri Khudadad Dungaji Government Ayurved Hospital GE Road ,Raipur CG,PIN-492001  
 
Primary Sponsor  
Name  Shri Khudadad Dungaji Government Ayurvedic Hospital 
Address  Shri Narayan Prasad Awasthi , Government Ayurved College Raipur , GE Road opposite NIT , Raipur , CG -India PIN-492010 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Department of Dravyagun Vigyan   Shri Narayan Prasad Awasthi Government Ayurved College,GE Road,Raipur Chhattisgarh India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPravin Kumar Joshi  Shri Khudadad Dungaji Government Ayurved Hospital ,Raipur  Department of Dravyagun Vigyan Special clinic room no.1 Shri Khudadad Dungaji Government Ayurved Hospital ,Raipur ,PIN-492001
Raipur
CHHATTISGARH 		 9407649488

pravinkumarjoshi7000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee Shri Narayan Prasad Awasthi Government Ayurved College , Raipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  both male and female between the ages of 20-40 yrs. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatavari, Reference: Shaligram Nighantu Bhushanam , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: Shaligram nighantu Bhushnam Part-7-8,Page no.-292
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Healthy individual who has given consent for clinical trial. 
 
ExclusionCriteria 
Details  1. With the history of any skin disease like psoriasis, dermatitis, herps, eczema, SLE,
ringworm .
2. History of hypersensitivity to drugs, sunlight, cosmetics.
3. Known hyper pigmentation since birth.
4. Female on OCP, pregnant women and lactating women.
5. Who were on any hormonal therapy.
6. Any other condition with the course of the treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
There will be significant effect of shatavari to improve skin complexion.  60 Days. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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
Modification(s)  		 N/A 
Date of First Enrollment (India)   10/12/2024 
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="1"
Months="6"
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   Complexion is a subject of social importance. It is most obvious external manifestation of our overall well being. Complexion is major criteria to assess beauty. All human being especially young generation desire to look good but due to there low complexion individual feel moral breakdown and lack of confidence hence facing depression in life which hampers day to day productivity in professional and personal life too. Ayurveda mention a lot of herbs in its treatise .These ayurvedic herbs give natural care to skin and also protect it from harmful side effects caused by chemicals present in modern beauty products . 
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