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CTRI Number  CTRI/2021/10/037338 [Registered on: 14/10/2021] Trial Registered Prospectively
Last Modified On: 14/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Shwadanshtradi rasayan for post covid -19 syndrome  
Scientific Title of Study   A Randomized Open Label Single Group Clinical Trial to Evaluate the Efficacy of Shwadanshtradi Rasayan in Rasakshay of Post Covid-19 patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chinmayee Pravin joshi 
Designation  PG Scholar 
Affiliation  Smt.K.C.Ajmera ayurved mahavidyalay dhule. 
Address  Department of Swasthavrutta Room No 12 Smt.KC Ajmera Ayurveda College Agra Road Dhule Maharashtra
15,Shriram Nagar Wadi Bhokar Road Deopur Dhule Maharashtra
Dhule
MAHARASHTRA
424002
India 
Phone  8669154827  
Fax    
Email  vdchinmayeejoshi05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajesh Shah 
Designation  Associate Professor 
Affiliation  Smt.K.C.Ajmera ayurved mahavidyalay dhule. Maharashtra 
Address  Department of Swasthavrutta Room No 12 Smt.K.C.Ajmera ayurved mahavidyalay dhule.Maharashtra

Dhule
MAHARASHTRA
424002
India 
Phone  8669154827  
Fax    
Email  ashtang.ayur.pharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chinmayee Pravin joshi 
Designation  PG Scholar 
Affiliation  Smt.K.C.Ajmera ayurved mahavidyalay dhule. Maharashtra 
Address  Department of Swasthavrutta , Room no 12 , Smt.K.C.Ajmera Ayurved Mahavidyalay Dhule , Maharashtra.
15, Shri Ram nagar wadi bhokar road deopur Dhule, Maharashtra.
Dhule
MAHARASHTRA
424002
India 
Phone  8669154827  
Fax    
Email  vdchinmayeejoshi05@gmail.com  
 
Source of Monetary or Material Support  
Ashtang Ayurved Pharmacy, E- 46 Avadhan MIDC, Dhule, Maharashtra. 
 
Primary Sponsor  
Name  Ashtang Ayurved Pharmacy Dhule 
Address  E- 46 Avadhan MIDC dhule. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Chinmayee Pravin Joshi  Smt.K.C.Ajmera Ayurved college , Dhule.  Department of Swasthavrutta ,Room no 12,Smt.K.C.Ajmera Ayurved college , Agra Road Deopur Dhule.
Dhule
MAHARASHTRA 		 8669154827

vdchinmayeejoshi05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Smt.K.C.Ajmera ayurved mahavidyalay dhule.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: Jwarottar Rasakshay, (2) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: Jwar Upadrava,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shwadanshtradi Rasayan, Reference: Ashtanghriday Uttarsthan chapter 39-rasayn adhyay verse no. 160, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i) Patients of Post Covid-19 came under duration of > 21 days to 1 year after RTPCR report.
ii) Patients of Post covid – 19 showing classic
feature of Rasakshay[23].
iii) Patients between age group of 18-70 years will be included.
iv) The patients will be included after Shodhana.
 
 
ExclusionCriteria 
Details  Patients with serious life threatening diseases will be
Excluded.
ii) Patients with age group below 18 and above 70 will be excluded.
iii) Pregnant women , children will be Excluded.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rasakshay in post covid -19 syndrome  day 0 and day 21 
 
Secondary Outcome  
Outcome  TimePoints 
Functional status Scale in post covid -19 patients  day 0 and day 21 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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/ Phase 3 
Date of First Enrollment (India)   21/10/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vdchinmayeejoshi05@gmail.com].

  6. For how long will this data be available start date provided 21-10-2021 and end date provided 21-10-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   After clearance from institutional ethical committee of Smt.K.C.Ajmera Ayurved College Dhule , A randomised open labelled single group clinical trial will be conducted on 35 patients with post covid -19 syndrome as per CONSORT statment and GCP guidelines.  Patients will be recruited after proper consent from opd, ipd and casulty of institute with history of RTPCR positive >21 days upto 1 year. Assesment of symptoms will be done by using Rasakshay scale and post covid functional status scale.
. quetions from rasakshay scale quesstionaire will be asked to the pateints and analyasis of the symptoms will be done. Shwadanshtradi rasayan, A classical Ayurvedic formulation mentioned in Vagbhat  which will be  prepared as per GMP guidelines will be given orall in dose of 5 gm morning empty stomach. follow up will be done on 7th , 14th day. same questions from the rasakshay quesstionaire and functional status scale quesstionaire will be asked on the follow up days. final assement will be done on 21st day.  
 
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