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CTRI Number  CTRI/2023/08/056216 [Registered on: 07/08/2023] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Purification of Conch Shell by Two Different Media and Its Effect in Pimples 
Scientific Title of Study   A Comparative Pharmaceutico-Clinical Study of Shankha Bhasma Shodhita by Two Different Media and Its Effect in Yuvanapidika With Special Reference To Acne Vulgaris 
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 VIJAY LAXMI DEVI 
Designation  M.D. Scholar, Rasa Shastra and Bhaishajya Kalpana Department 
Affiliation  Government P.G. Ayurvedic College And Hospital, Varanasi 
Address  Government P.G. Ayurvedic College And Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8736953347  
Fax    
Email  drvijaylxmi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VIJAY LAXMI DEVI 
Designation  M.D. Scholar, Rasa Shastra and Bhaishajya Kalpana Department 
Affiliation  Government P.G. Ayurvedic College And Hospital, Varanasi 
Address  Government P.G. Ayurvedic College And Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8736953347  
Fax    
Email  drvijaylxmi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VIJAY LAXMI DEVI 
Designation  M.D. Scholar, Rasashastra and Bhaishajya Kalpana Department 
Affiliation  Government P.G. Ayurvedic College And Hospital, Varanasi 
Address  Government P.G. Ayurvedic College And Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8736953347  
Fax    
Email  drvijaylxmi@gmail.com  
 
Source of Monetary or Material Support  
Government P.G. Ayurvedic College And Hospital, Varanasi 
 
Primary Sponsor  
Name  Government PG Ayurvedic College And Hospital Varanasi 
Address  Department of Rasashastra and Bhaishajya Kalpana, Government P.G. Ayurvedic College And Hospital, Varanasi 
Type of Sponsor  Research institution and hospital 
 
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 ANKIT KUMAR GUPTA  Government P.G. Ayurvedic College and Hospital, Varanasi  OPD of Department of Rasashastra And Bhaishajya Kalpana and Department of Kayachikitsa, Government P.G. Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH 		 8299778299

drankitg01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Government Ayurveda College and Hospital, Varanasi U.P, Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Individuals of acne vulgaris having Pidika with clinical symptoms.
2. Patients having history of yuvanpidika within 6 months.
3. Uncomplicated cases with classical symptoms of Yuvanpidika were selected irrespective of cast, religion and profession.
 
 
ExclusionCriteria 
Details  1. Patients having Pidika other than face and other Kshudraroga and Kustharoga.
2. Pidika produced due to side effect of any drug applied earlier.
3. Patients below 16 yrs and above 45 yrs of age.
4. Individuals suffering from systemic pathologies like SLE, cancer, severe hormonal imbalance etc.
5. Patients on medication of hormonal therapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction In Growth of New Acne Vulgaris  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Complete Relief from Acne Vulgaris  12 weeks 
 
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 2 
Date of First Enrollment (India)   15/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2023 
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)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

This Study is a randomized, parallel group study trial comparing the efficacy of Shankha Bhasma shodhita by two different media. Patients were randomly be selected from OPD of Department of Rasashastra and Bhaishajya Kalpana and Kayachikitsa, Government PG Ayurveda College and Hospital, Varanasi. 60 Patients were studied under 2 groups having 30 patients in each group:

Group 1: 30 Patients were  treated with oral administration of Shankha Bhasma Shodhita by Chaulayi Swarasa along with Shalmali Kantaka Lepa over affected part of the face.

Group 2: 30 Patients were  treated with oral administration of Shankha Bhasma Shodhita by Nimbu Swarasa along with Shalmali Kantaka Lepa over affected part of the face.

Follow up was done after every 15 days of treatment in each group

Statistical method of Analysis: The parameters of baseline data was compared with the follow up status for assessment of results. All result analysis will be done by using SPSS latest version, and obtained result was analysed clinically & scientifically by employing some statically test between the group & also within the groups such as paired t-test.

 
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