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CTRI Number  CTRI/2021/09/036485 [Registered on: 14/09/2021] Trial Registered Prospectively
Last Modified On: 13/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of vishaghna mahakashaya tablet and lodhradi lepa in the acne cosmetica 
Scientific Title of Study   Role of vishaghna mahakashaya ghanvati and lodhradi lepa in the clinical management of aalepa janya mukhdooshika w.s.r. to acne cosmetica 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Upadhyay 
Designation  Pg scholer 
Affiliation  Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh 
Address  Department of Agada tantra Evum Vidhi Ayurved, Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  8770344869  
Fax    
Email  drpariupadhyay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S R Inchulkar 
Designation  Guide 
Affiliation  Shri Narayan Prasad Awasthi government ayurved college Raipur Chhattisgarh. 
Address  Department of Agada tantra Evum Vidhi Ayurved, Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr S R Inchulkar 
Designation  Guide 
Affiliation  Shri Narayan Prasad Awasthi government ayurved college Raipur Chhattisgarh. 
Address  Department of Agada tantra Evum Vidhi Ayurved, Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh

Raipur
CHHATTISGARH
492001
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Agada Tantra Evum Vidhi Ayurved, Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh 
 
Primary Sponsor  
Name  Dr Pooja Upadhyay 
Address  Shri Narayan Prasad Awasthi government ayurvedic College raipur chhattisgarh 
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 Pooja Upadhyay  Shri Khudadad Dungaji government ayurved hospital Raipur Chhattisgarh  OPD no. 2, Kayachikitsa(medicine department)
Raipur
CHHATTISGARH 		 8770344869

drpariupadhyay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee office of The Principal government ayurved college Raipur Chhattisgarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L708||Other acne. Ayurveda Condition: Mukhdushika,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vishaghna Mahakashaya Ghanavati, Reference: Charak Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Lodhradi Lepa, Reference: Sharangdhara samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: .
3Intervention ArmDrugClassical(1) Medicine Name: Vishaghna Mahakashaya Ghanavati and Lodhradi lepa, Reference: Charak Samhita and sharangdhara samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patient between the age of 18 to 40 years randomly included for study.
2. Patient using chemically prepared cosmetics regularly.
3. Sex- both male and female.
4. Diagnosed patient with clinical features of Acne Cosmetica acc. to ayurveda and modern. 
 
ExclusionCriteria 
Details  1. Patients having complaint for more than 5 years.
2. Patient below the age of 18 years and above age of 40 years.
3. Patient not using chemically prepared cosmetic regularly.
4 Any skin disease on face like Folliculitis, Rosacea other than Acne Cosmetica. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparing the effect of Vishaghna mahakashaya and Lodhradi lepa in Acne Cosmetica before and after intervention.  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in subjective and objective parameters after the treatment.  At the end of 2 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   20/09/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Study is multiple arm Open label prospective randomized clinical trial on Role of Vishaghna Mahakashaya Ghanvati and Lodhradi lepa in the clinical management of Aalepa janya Mukhdushika w.s.r. to  Acne Cosmetica . Patients will be selected from OPD dept. of kayachikitsa of Shri khudadad dungaji govt. ayurved hospital Raipur Chhattisgarh. Three groups A, B, C will be taken into clinical trial each containing 20 patients. where group A will receive Vishaghna Mahakashaya Ghanvati group B will receive Lodhradi lepa and group C will be given both for 28 days. Assessment will be done on the basis of subjective and objective parameters before and after intervention. 
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