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CTRI Number  CTRI/2024/05/067471 [Registered on: 16/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Effect of Marichadi Taila And Vidangadi Guggulu On Pama Kustha W.S.R. To Scabies 
Scientific Title of Study   Pharmaceutico Clinical Study Of Marichadi Taila And Vidangadi Guggulu On Pama Kustha W.S.R To Scabies 
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 Jayanta Bag 
Designation  MD Scholar(Ay.) Department of Rasa Shastra And Bhaishajya Kalpana 
Affiliation  Government Ayurvedic College And Hospital 
Address  Department of Rasa Shastra And Bhaishajya Kalpana,Government Ayurvedic College And Hospital Patna Kadamkuan Patna Bihar

Patna
BIHAR
800003
India 
Phone  9937824007  
Fax    
Email  drjb007rsvd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neetu Singh 
Designation  Assistant Professor Rasa Shastra And Bhaishajya Kalpana Government Ayurvedic College And Hospital 
Affiliation  Government Ayurvedic College And Hospital 
Address  Department of Rasa Shastra And Bhaishajya Kalpana Government Ayurvedic College And Hospital Patna Kadamkuan Patna Bihar

Patna
BIHAR
800003
India 
Phone  7091141115  
Fax    
Email  singhneetu17@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neetu Singh 
Designation  Assistant Professor Rasa Shastra And Bhaishajya Kalpana Government Ayurvedic College And Hospital 
Affiliation  Government Ayurvedic College And Hospital 
Address  Department of Rasa Shastra And Bhaishajya Kalpana Government Ayurvedic College And Hospital Patna Kadamkuan Patna Bihar

Patna
BIHAR
800003
India 
Phone  7091141115  
Fax    
Email  singhneetu17@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College And Hospital, Patna, Bihar 
 
Primary Sponsor  
Name  Dr Jayanta Bag 
Address  Department of Rasa Shastra & Bhaisajya Kalpana, Government Ayurvedic College And Hospital ,near budhmurti,Patna, Bihar-800003, India 
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 Jayanta Bag  Government Ayurvedic College And Hospital Patna  Departament of Rasa SHastra & Bhaishajya Kalpana, OPD room No-10 ,Kadamkuan Patna-800003, Bihar.
Patna
BIHAR 		 9937824007

drjb007rsvd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: PAMA (KACCU),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: MARICHADI TAILA , Reference: Sarangadhar Samhita madhyam khanda 9/148-152, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: VIDANGADI GUGGULU, Reference: Chakradatta vrana sotha chikitsa 44/74, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient willing for trial.
Selected sign and symptoms based on both Ayurvedic & modern context.
Age group between 08-70 year 
 
ExclusionCriteria 
Details  Age above 08 year and below 70 years.
Patients having any systemic illness like - T: B, Hepatitis -B, AIDS etc.
Pregnant women and lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Marichadi tails & vidangadi Guggul on Pama Roga w.s.r to scabies in clinical trail.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To see the preparation of safe, effective, and quality drug and standardization.  30 days  
 
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)   25/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drjb007rsvd@gmail.com].

  6. For how long will this data be available start date provided 25-04-2025 and end date provided 15-03-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
All the patients will be evaluated on the basis of their age, sex, religion, climatic condition,socio-economic status, education status, occupation, nature of work, economical status, marital status, Prakriti, Dosha, Agni, kostha, and subjective and objective parameters of an open label interventional prospective trail to study the pharmaceutico clinical study of Marichadi tails and vidangadi guggul on Pama kustha w.s.r to scabies in 2 groups each containing 30 patients. This study will be conducted in Government Ayurvedic College and Hospital, Patna, Bihar in the department of Rasa Shastra evam Bhaishajya Kalpana. After 07 days of intervention three  follow up will be done every 07 days for total duration of study i.e of 30 days.
 
 
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